Real Talk: Understanding Patient Perspectives and Real-World Data in Actinic Keratosis

Review the latest clinical and real-world data for current therapies for actinic keratosis (AK)

Identify appropriate therapies for AK treatment considering patient preferences

WCM25: Real Talk: Understanding Patient Perspectives and Real-World Data in Actinic Keratosis: An Online Activity

Define the various therapies available for the management of actinic keratosis

Describe expert recommended approaches for integrating combination AK therapies into practice

Identify approaches for delivering optimal patient-tailored AK therapeutic care 

FC24: Real-World Approaches to Actinic Keratosis Management: An Online Activity

Describe the key data on photodynamic therapy to manage actinic keratosis 

Identify patients with actinic keratosis for photodynamic therapy 

Discuss strategies to optimize care of patients with actinic keratosis with photodynamic therapy 

2023 Virtual Grand Rounds Session 10: September 6, 2023 - Case Conversations: Optimizing PDT In Your Practice One Patient at a Time

Describe the key data on photodynamic therapy to manage actinic keratosis

Identify patients with actinic keratosis for photodynamic therapy

Discuss strategies to optimize care of patients with actinic keratosis with photodynamic therapy

'HowTo' Incorporate PDT into Your Daily Practice: Microlearning CME Activity

Well, hello, I'm Dr. Neil Batia from San Diego. And I'm Dr. Jonathan Weiss in Atlanta, Georgia. And my good friend John and I are going to discuss how to incorporate photodynamic therapy into your daily practice. And we'd like to thank biofantera for supporting an educational grant for this CME activity. Activity has been planned and through the Fred education group, it's good for zero point 25 category one credits. And John and I are going to give you some nuts and bolts of how to make PGT part of the practice. And John, we just start off always with definitions, right? And how do we define aks? And I always take a minute to just poke fun at the word pre because we always use the word pre cancer. And is it really the right term for aks? And I just laugh about the prefix pre because kind of like boarding the plane. We're both frequent flyers. We know that pre boarding is still boarding. Everyone makes a joke of it. Pregame is still part of the game. And prediabetes doesn't exist. It's not really a real term, just from commercials, but precancers is how we talk about aks with patients. And we remind ourselves these are potentially going to turn into squam. What we forget is often anywhere from 80 to almost 100% of aks, I'm sorry, of squamous cells had an ak as a precursor, and we need to kind of emphasize that to patients thinking about that. But I'll ask you, I mean, if you look at this patient in the field, this is from the academy website. You look at the field and you see the aks with the arrows. Tell me what your thoughts are about. Who's your treatment patient regimen? Is it for BDT, topicals or liquid nitrogen? Yeah. I honestly feel that a patient like this can benefit from some sort of field therapy. This is a patient who has what we used to refer to as field cancerization. They've got a bunch of cancers waiting to happen, and so there's dna damage all over the place, and we need to use a field therapy. So I would go with PDT or another field therapy, a topical field therapy, depending on what the exact circumstances were with the patient, could they come into the office for it? Basically. So as we kind of drive the concept of patient selection, I'm just getting into what patients have done. What are their phobias? What are they interested in their outcomes for the long term? Tell me again what your thoughts are about someone who's had maybe a couple of skin cancers before or maybe this is their first AK. How do we make that conversation turn into a regimen that's successful? I think we need to look at them very carefully, Neil, and ask ourselves, is this a patient who would benefit from field therapy? And I think that's almost every patient with an AK, because where there's one, like you say, there's going to be more and there's likely to be a cancer, especially those with that intertwining disease, where you can see aks intertwining if they've had other history of other field therapies. I like to think about PDT because it's very different than the others. I do like it as initial therapy in some patients, and I like to combine it with other treatments, sort of as adjuvant therapy. And especially in those patients with history of nonmelanomal skin cancer. Yeah. And that's one thing that's important that we have to learn from ourselves, is there's no real single recipe of priming the skin or pretreatment. We can use any of the topicals, five fu, amicomod, turbinebulin, what have you, as pretreatment. We can even use retinoids as pretreatment and post treatment to maintain the gains. Think about in terms of PDT and who's a PDT candidate. We kind of have to choose not only the type of light, the strength of ALA, but actually who is that PDT candidate, like we saw with that patient on the cheeks. And if you can go over the kind of the subtle differences between blue and red, as well as 20 and 10%, what do you see here in terms of some of the major differences we should all be aware of? Yeah. So to answer your first question is, I think any patient who can sit up for ten to 20 minutes is a candidate for PDT. The main differences between blue and red light are largely in the formulations. One's a solution that is used with the blue light, the gel with the red light, and the amount of incubation time is key, because with the red light, it's optimal at 3 hours. With the blue light, it's 14 to 18 hours. There are differences there. For the blue light, you get to go home and then come in the next day to be treated, whereas with the red light, you generally stay in the office for the incubation period. Yeah. It's interesting, too, when you think about the Role of Occlusion. A lot of these studies came from Germany, where they actually did occlusion with a light plastic wrap over the forehead. And ears, which isn't something we typically do here, but we do use occlusion with wrap on the extremities and we have to actually get 3 hours of incubation time to really maximize the efficacy. And as you see at the bottom of the graph, there's understanding about the different wavelengths as well as the color of the light blue and red. But more importantly, it's thinking about how are we doing it correctly and what mistakes are commonly being made. We hear a lot about using steroids as a pretreatment moisturizer being enough cooling the skin. These are all misconceptions that have actually led to poor outcomes. And I'll bring everyone's attention to these two graphs. The best conversion of AlA to protoporphin nine actually comes from 2 hours incubation, where you see the logarithmic Conversion here and you see 60 minutes versus 120 minutes and how much difference there is in the fluorescence of actual protoporphin nine conversion. The other graph on the right actually shows how much change in promoting apoptosis there is with warmer temperatures. But what kind of strategies, John, do you think we need to incorporate to maximize these outcomes? Clearly to me what we do in our practice is we try to incubate as close to 120 minutes, 2 hours as absolutely possible. You want that maximal conversion to the protoporphin nine, and then you want to get the skin heated up with some help, which we'll talk about some cooling as best you can to as high a temperature close to that 42 degrees celsius that you can very important in order to get that apoptosis and get the best results. Neil. And we've seen where you can increase the temperature in the room. You can actually use warming blankets, things like that. But you want to be a little careful with the face. You can use a space heater even, but in the room itself, a mist, a good fan, you can actually cool the temperature in the room of the time in the light, and then of course make the patient as comfortable as possible. Which kind of leads to the next question. What else do we do pretreatment wise? Do you have a special regimen you like to pretreat the patients or kind of maintain the gains? So I actually like both of the chemical and physical sides. I like to use a pretreatment with a retinoid, a lactic acid or five fu even to get patients to get rid of a lot of the scale and maybe some of the more hypertrophic aspects. And then debridement is very key and just roughly abrading with gauze, but even with a little microdermabrasion or curitage if they need it, and if you need to, you can even anesthetize, as we've talked about, with a little lidocaine to get that good curitage on some of the lesions. Yeah. And that maximizes comfort, but also, again, maximizes efficacy. And also for reimbursement, you use the other code when curitage is actually involved. It's a CPT code that reimburses better. We've done some studies on microneedling, and there are a lot of published studies on pretreatments with all modalities, five fu retinoids, mechamod. There'll even be some information about turbinabulin down the road. And I think even more so is what we do afterwards. And you think about that patient whose discomfort is limiting. I'm sure we've had some older patients, for example, who have had a couple of treatments, they've got a little phobia of liquid nitrogen. They don't want to get under the light again. They think they're going to get burned. What kind of things do we do as far as maximizing their pain? Some would say change the interval between treatment. Some would say shorten incubation time. I look at what can we do on the day of and the day after treatment. Some of the topical preparations, things like antihistamines, both a day or two afterwards as well as a day of treatment. I've even given things like Xanax and a couple of things under the light. What kind of opportunities do we have here to maximize their comfort during the treatment? Well, I think it all starts, actually, when you first meet the patient and bring up the PDT, counseling them beforehand about what they can expect. A little bit, that there will be a little bit of pain, but there is a lot of gain at the back end of it. And the things that I like to do is have my staff coach them through the treatment, check in every few minutes to make sure they're doing okay. The cooling fans are absolutely important to us. Keeping them cool misted does not decrease the effect of the light. You don't want to use any direct cooling devices, like a Zimmer unit that we have for our lasers. You don't want to do that. That's getting it too cool. But just keeping them as comfortable as possible, letting them know you're there, and letting them know that if you need to, you can modify the treatment for that special patient who's had a bad experience. If they don't want to do it again, you can say, we can modify it, we can check in every three minutes or so and make sure. And we can turn the lights off and then turn them back on again for you when you've cooled down a little bit. So all of those are very good. And then post care is very important. Coaching them through the post care with sunscreens and moisturizers. Like you said, maybe a little light of cane cream, not too much, but that may help a lot as well. Yeah. And one of the biggest fallacies we've heard about is treating in the summer. And one thing I always think about is like, well, why would it be any different, right? We're still doing the light treatment. We're keeping the patients indoors for a day. But what do we tell our colleagues about scheduling in the summer months? Is there any real issue for that? I don't see any, but I'm sure we need to tell people something. Yeah, I really don't either, Neil. I mean, you and I both live in sunny climates, and so we have nine months of summer in Atlanta, maybe ten, and you have it year round. And this is something we do year round, just making sure we use great photo protection. It's really only two days that they have to be extra careful when the ALA may still be on their skin and might be activated by sunlight. And we just make sure that they use mineral based sunscreens. Good photo protective behavior, that's the most important thing. And that's good because we have a lot of good opportunities. There's good studies underway that have already built on what we've done. We're learning a lot about coding and reimbursement strategies, but I like the way you think about things. Have a champion in the office, right? Absolutely. That's the key. Make sure you've got enough patience for it. You probably do. Most of us do have enough patients for it. Make sure you understand the coding and reimbursement, have a good process for getting a patient into the treatment, and then make sure you've got that champion, both a dermatologist and a staff member who's going to remind everybody that you have this available for your patients and have the system down pat. But kind of a synopsis again. There's a lot of good data in the clinical trial arena for PDT. There's a lot of misconception about space. I mean, we talk about tying up rooms. Anything you'd want to advocate as far as just getting started, especially to our dermatologist colleagues in the first five years out. How do they get the ball rolling? I think the key is to research it for your own practice. You can figure out the number of patients for whom you've treated with field therapy through your EMR. Make sure you have just a little bit of space, understand the coding and reimbursement, then figure out the process before you get started so it's seamless for the patient. And you need two champions. You need a dermatologist champion in your office, and you need one staff champion to help remind people that this is a viable treatment for your patients and to keep it going on a regular basis. Yeah, well, John's always a pleasure. Even though we're three time zones apart, it's always feel like I'm sitting next to you. So thank. Absolutely. Absolutely. Neil, we've been doing this for a very long time, much longer than either of us would like to know, and we're going to keep doing it. Absolutely. Thanks. And this was how to. To incorporate PDT into practice. Take care, everybody.

2023 Virtual Grand Rounds Session 2: March 1, 2023 - Optimizing Photodynamic Therapy in Your Practice Today for Better Actinic Keratosis Outcomes Tomorrow

Actinic Keratosis

WEDNESDAY, Feb. 12, 2025 -- Use of immune checkpoint inhibitors (ICIs) for any cancer is associated with a significant reduction in actinic keratoses (AKs), according to a study published online Feb. 12 in JAMA Dermatology.Charlotte Cox, M.D., from the University of Queensland in Brisbane, Australia, and colleagues conducted a prospective cohort study to examine the association of ICIs with changes in field cancerization assessed by the number of AKs and keratinocyte carcinomas (KCs) at baseline versus 12 months after starting ICI therapy. Consecutive immunocompetent adults starting therapy with an inhibitor for programmed cell death 1 or programmed cell death ligand 1 for any active cancer with clinical AKs on their forearms were eligible; 23 participants were recruited, four of whom died due to disease progression.The researchers observed a significant decrease in the mean AK number, from 47.2 at baseline to 14.3 at 12 months. The likelihood of having a 65 percent or greater reduction in AK numbers was increased for younger patients and those with a history of blistering sunburn. In the 12 months before to the 12 months after starting ICI therapy, KC total numbers decreased from 42 to 17. In the same period, the number of cutaneous squamous cell carcinomas decreased from 16 to five."This pilot cohort study highlights the potential association of ICI therapy, originally used in cancer treatment, with significant reduction of clinical AKs," the authors write. "However, the observed reduction in cutaneous squamous cell carcinomas occurrence was not statistically significant."Several authors disclosed ties to the pharmaceutical and skin care industries.

Reduction seen in keratinocyte carcinoma total numbers from 42 to 17 in 12 months before versus after starting ICI therapy

Immune Checkpoint Inhibitors Appear to Reduce Actinic Keratoses

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</div>Watch as Dr James Del Rosso, DO, discusses the significance of the expanded indication, including the clinical efficacy, duration of treatment, and more&nbsp;Almirall has recently announced that the US Food and Drug Administration (FDA) has approved an expansion of the use of Klisyri (tirbanibulin) for the treatment of actinic keratosis (AK). Initially approved in December 2020 for smaller areas, this expansion will change the previous Klisyri dosing for surface area treatment from up to 25 cm2 to up to 100 cm2, allowing clinicians to treat a larger area of the face or balding scalp.&nbsp;This new approval significantly enhances the convenience and flexibility for both patients and dermatologists in managing more extensive manifestations of AK.&nbsp;Consistent safety and efficacy in larger treatment areas&nbsp;The FDA's approval was based on a robust Phase 3 clinical trial, which evaluated the safety and tolerability of applying Klisyri over an area of 100 cm2 on the face or balding scalp, which is 4 times larger than the initially approved 25 cm2. The study, conducted in multiple centers across the US, demonstrated that the safety and tolerability profiles of Klisyri in this expanded area are consistent with those observed in the original trials. Local skin reactions and adverse events remained in line with the initial findings.&nbsp;Availability and packaging&nbsp;Klisyri will be available in 2 package sizes to accommodate different treatment needs: a 250-mg package for treating up to 25 cm2 and a new 350-mg package for treating up to 100 cm2. This ensures that patients and healthcare providers have the appropriate resources to address varying degrees of AK.

The expanded indication increases the treatment area on the face and scalp from 25 cm2 to 100 cm2

LAUNCH ALERT: FDA Expands Approval of Klisyri for Broader Actinic Keratosis Treatment 

WEDNESDAY, Nov. 8, 2023 -- Medicare beneficiaries with actinic keratoses (AKs) have an increased risk for skin cancer, according to a study published online Nov. 8 in JAMA Dermatology.Cassandra Mohr, from The University of Texas MD Anderson Cancer Center in Houston, and colleagues calculated the absolute and relative risks for future skin cancer in a retrospective cohort study performed using a random sample of 4,999,999 fee-for-service Medicare beneficiaries from 2009 through 2018. Patients with treated AKs were included and compared to a group of patients with seborrheic keratoses (SKs). The analysis included 555,945 patients with AKs (mean age, 74.0 years) and 481,024 patients with SKs (mean age, 73.3 years).The researchers found that the absolute risk for skin cancer after a first AK was 6.3, 18.4, and 28.5 percent at one, three, and five years, respectively. Compared with patients with SKs, patients with AKs had an increased risk for skin cancer (adjusted hazard ratios, 2.17, 2.20, 2.63, 1.85, and 1.67 for any skin cancer, keratinocyte carcinoma, squamous cell carcinoma [SCC], basal cell carcinoma [BCC], and melanoma, respectively)."AKs may be valuable clinical markers of skin cancer risk, including SCC, BCC, and melanoma," the authors write. "Efforts to develop evidence-based recommendations for skin cancer surveillance in patients with AKs are paramount."

Increased risk seen for any skin cancer, keratinocyte carcinoma, squamous cell carcinoma, basal cell carcinoma, and melanoma

Is There an Increased Risk for Skin Cancer for Older Adults With Actinic Keratoses?

WEDNESDAY, May 24, 2023 -- Tirbanibulin is effective for treatment of actinic keratosis (AK), according to a study published in the May issue of SKIN.Todd Schlesinger, M.D., from the Clinical Research Center of the Carolinas in Charleston, South Carolina, and colleagues examined patient- and clinician-reported outcomes among 290 adults with AK on the face or scalp who were prescribed tirbanibulin in real-world clinical practice.The researchers found that at week 8, Skindex-16 quality-of-life scores improved in all domains (mean change from baseline, −14.3, −24.9, and −9.8 in symptoms, emotions, and functioning domains, respectively). High overall satisfaction with tirbanibulin was reported by clinicians and patients (mean scores, 78.8 and 74.5, respectively). From baseline to week 8, there was improvement in overall skin appearance (91.0 and 84.1 percent reported by clinicians and patients, respectively). Tirbanibulin had shorter skin reaction duration, milder skin reaction severity, and better daily activities impact compared with previous treatments and was easier to use. Overall, 73.8 percent of the patients achieved Investigator's Global Assessment success (0 to 1). From baseline to week 8, there was a reduction observed in skin photodamage severity (77.4 to 39.6 percent)."In real-world routine community practice, tirbanibulin treatment demonstrated effectiveness, as evidenced in Phase III clinical trials, highlighting the clinical and humanistic benefits associated with this novel therapeutic option for optimal management of AKs," the authors write.Several authors disclosed ties to pharmaceutical companies, including Almirall, which manufactures tirbanibulin and funded the study.

Improvement seen in Skindex-16 quality-of-life scores in symptoms, emotions, functioning domains at week 8 with tirbanibulin

Is Tirbanibulin Effective for Treating Actinic Keratosis?

Nearly three in 10 Medicare beneficiaries have at least one actinic keratosis diagnosis encounter over five years of follow-up, according to a research letter published online July 27 in
 
 JAMA Dermatology
 
 .




 Lucy J. Navsaria, M.B.B.Ch., from University of Texas MD Anderson Cancer Center in Houston, and colleagues used Medicare claims data (2009 to 2018) to identify beneficiaries without Medicare Advantage coverage (fee-for-service only) but with continuous Parts A, B, and D coverage. The authors sought to examine incidences and treatment patterns associated with actinic keratosis.




 The researchers found that 29.3 percent of beneficiaries had one or more actinic keratosis diagnosis encounters. Of 8.18 million actinic keratosis diagnosis encounters (mean of 5.59 per patient), most occurred with dermatologists (78.6 percent) and physician assistants or nurse practitioners (10.4 percent). Topical fluorouracil was used in 2.3 percent of encounters. The raw incidence rate of actinic keratosis diagnosis encounters with treatments was higher for men versus women and for White patients versus all other race and ethnicity groups.




 "Actinic keratosis is a major public health problem for U.S. older adults," the authors write. "The findings demonstrated high incidence rates and suggested an opportunity for squamous cell carcinoma prevention through increased use of topical fluorouracil."




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Authors say increased use of topical fluorouracil may be warranted

Actinic Keratosis Diagnosed in Almost One-Third of Older Adults

For patients with actinic keratosis (AK) lesions, the risk for invasive cutaneous squamous cell carcinoma (cSCC) is increased for those with severe AK and especially for those who require additional treatment, according to a study published online April 27 in
 
 JAMA Dermatology
 
 .




 Shima Ahmady, M.D., from Maastricht University Medical Center in the Netherlands, and colleagues examined the risk for invasive cSCC and factors that may contribute to increased risk among patients with multiple AKs. Participants included 624 patients with a minimum of five AKs within an area of 25 to 100 cm
 
 2
 
 on the head, who were randomly assigned to treatment with 5 percent fluorouracil, 5 percent imiquimod cream, methylaminolevulinate photodynamic therapy, or 0.015 percent ingenol mebutate gel.




 The researchers found that during follow-up, 26 patients were diagnosed with a histologically proven invasive cSCC in the target area. The total four-year risk was 3.7 percent for developing cSCC in a previously treated area of AK and varied from 2.2 to 5.8 percent for patients treated with fluorouracil and imiquimod, respectively. The risk was 20.9 percent in patients with severe AK (Olsen grade III) and was especially high (33.5 percent) for those with severe AK who needed additional treatment.




 "The risk of invasive cSCC was highest in patients with Olsen grade III AK lesions and was substantially increased in patients who received additional treatment," the authors write. "We therefore recommend close follow-up of these patients."




 One author disclosed financial ties to the pharmaceutical industry.




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Risk increased in patients with Olsen grade III lesions and especially for those who needed additional treatment

Does Invasive cSCC Risk Increase With Severe Actinic Keratosis Lesions?

For patients with actinic keratoses (AK), high-dose oral vitamin D3 (VD3) significantly improves response to photodynamic therapy (PDT), according to a study published online March 18 in the
 
 Journal of the American Academy of Dermatology
 
 .




 Noting that VD3 combined with PDT can improve clearance of AK in mouse skin cancer models, Taylor A. Bullock, M.D., from the Lerner Research Institute in Cleveland, and colleagues examined whether oral VD3 can improve clinical efficacy of a PDT regimen in humans with AK. Twenty-nine patients received gentle debridement and 15 minutes of 5-aminolevulinic acid preincubation, followed by blue light (30 minutes; 20 J/cm
 
 2
 
 ; group 1) and 29 patients took oral VD3 daily (10,000 IU daily for five or 14 days) prior to debridement/PDT (group 2).




 The researchers found that the mean clearance rates of facial AK were lower in group 1 for patients with VD3 deficiency (25 hydroxyvitamin D3 [25OH-D3], &lt;31 ng/dL) compared with those with normal 25OH-D3 levels (clearance rate, 40.9 ± 42 percent versus 62.6 ± 14.2 percent). Compared with group 1, overall AK lesion response was significantly improved with high-dose VD3 supplementation (group 2; 72.5 ± 13.6 versus 54.4 ± 22.8 percent). Side effects did not differ between the groups.




 "Despite remaining biological unknowns, the practical value of this new VD3/PDT regimen is that practitioners can use it immediately to benefit patients with widespread facial AK," the authors write.




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Patients receiving high-dose oral vitamin D3 prior to photodynamic therapy had improved clearance rates of facial AK

Does Oral Vitamin D3 Improve Response to PDT in Actinic Keratoses?

In this episode of The Spot Check, host Jamie Restivo, MPAS, PA-C, welcomes Fabrizio Galimberti, MD, PhD, dermatologist and Medical Director at Conway Medical Center, for an engaging discussion on one of the most common yet deceptively complex conditions seen in clinical practice, actinic keratoses (AKs).Dr Galimberti emphasizes the importance of distinguishing AKs from “dry skin,” reminding listeners that these are pre-cancerous lesions with the potential to progress to squamous cell carcinoma, which is responsible for more deaths annually than melanoma. Together, he and Restivo unpack the art and science of combining cryotherapy and field therapy, with data showing a reduced burden of both pre-cancerous and cancerous lesions when these treatments are paired. “This is a chronic condition,” Dr Galimberti notes. “We need to treat for now and for the future.”The conversation explores how photodynamic therapy (PDT) fits into the AK treatment paradigm, offering controlled, in-office precision with cosmetic benefits and no risk of scarring. Dr Galimberti outlines his evolving patient-selection criteria, insights on optimizing incubation times, and the growing promise of painless PDT. He also shares pragmatic workflow pearls, like scheduling PDT and follow-up appointments simultaneously, to improve adherence and outcomes.Listeners will gain a grounded, practice-ready framework for treating AKs holistically: balancing efficacy, tolerability, and patient experience while addressing both visible and subclinical disease.&nbsp;

Fabrizio Galimberti, MD, PhD

The Spot Check

Let There Be Light: Integrating PDT into Clinical Practice for Actinic Keratoses

In Episode 21 of Derms and Conditions, our host James Q. Del Rosso, DO speaks with Mark Lebwohl, MD, Dean for Clinical Therapeutics and&nbsp;Chairman Emeritus at Icahn School of Medicine at Mount Sinai. Dr. Lebwohl discusses field treatments of actinic keratosis (AK).

In Episode 21 of Derms and Conditions, our host James Q. Del Rosso, DO speaks with Mark Lebwohl, MD, Dean for Clinical Therapeutics and&nbsp;Chairman Emeritus at Icahn School of Medicine at Mount Sinai. Dr. Lebwohl discusses field treatments of actinic keratosis (AK). He also discusses the benefits and disadvantages of imiquimod, 5-FU and tirbanibulin. Specifically, the anticipated reactions of topical AK treatments are highlighted. Advice on medication coverage is discussed next. After the patient receives the medication, Dr. Lebwohl ends the episode by giving some tips on treatment with topical AK therapies. FINANCIAL DISCLOSURES: JAMES DEL ROSSO, DO: CONSULTANT/ADVISOR Abbvie, Aclaris, Almirall, Amgen, Arcutis, Bausch Health (Ortho Dermatology), BioFrontera, BioPharmX, Bristol-Myers-Squibb, Cassiopea, Dermata, Dermavant, Encore, EPI Health, Evommune, Ferndale, Galderma, Incyte, JEM Health, Leo Pharma, La Roche Posay, Lilly (Dermira), MC2, Novan, Pfizer, Regeneron, Sanofi-Genzyme, SolGel, Sonoma (IntraDerm), Sun Pharma, Trevi, UCB, Verrica, Vyne (Foamix; Menlo) SPEAKER BUREAU Aclaris, Almirall, Amgen, Arcutis, Bausch Health (Ortho Dermatology), EPI Health, Ferndale, Galderma, Genentech, JEM Health, Leo Pharma, La Roche Posay, Lilly (Dermira), Pfizer, Regeneron, Sanofi-Genzyme, Sun Pharma, UCB, Verrica, Vyne (Foamix; Menlo) RESEARCH INVESTIGATOR Aclaris, Almirall, Amgen, Anaptys Bio, Arcutis, Athenex, Bausch Health (Ortho Dermatology), BioPharmX, Biorasi, Botanix, Brickell, Cara Therapeutics, Cassiopea, Dermavant, EPI Health, Ferndale, Galderma, Incyte, Leo Pharma, Lilly (Dermira), Novan, Pfizer, Ralexar, Regeneron, SolGel, Sun Pharma, UCB, Verrica, Vyne (Foamix; Menlo). Mark Lebwohl, MD Mark Lebwohl is an employee of Mount Sinai and receives research funds from: Abbvie, Amgen, Arcutis, Boehringer Ingelheim, Dermavant Sciences, Eli Lilly, Incyte, Janssen Research &amp; Development, LLC, Leo Pharmaceuticals, Ortho Dermatologics, Pfizer, and UCB, Inc. Dr. Lebwohl is also a consultant for Aditum Bio, Allergan, Almirall, Arcutis, Inc., Avotres Therapeutics, BirchBioMed lnc. BMD Skincare, Inc., Boehringer-Ingelheim, Bristol-Myers Squibb, Cara Therapeutics, Castle Biosciences, Corrona, Dermavant Sciences, EMD Serono, Evelo Biosciences, Facilitation of International Dermatology Education, Foundation for Research and Education in Dermatology, Helsinn Therapeutics, Inozyme Pharma, Kyowa Kirin, LEO Pharma, Meiji Seika Pharma, Menlo, Mitsubishi, Neuroderm, Pfizer, Promius/Dr. Reddy's Laboratories, Theravance, and Verrica.

Derms and Conditions Podcast

When Cryotherapy Alone Gets Too Cold: Topical Field Therapy for Actinic Keratoses

This episode is sponsored by Almerals and Conditions podcast. Hello, everyone, and welcome today to another edition of Derms and Conditions. And I'm very excited. We have a powerhouse in dermatology today, a colleague and great friend, Dr. Mark Leball, who's a leader in dermatology, practicing dermatology, teaching dermatology. So we're going to have a great program today. And Mark is dean for clinical therapeutics at the Icon School of Medicine at Mount Sinai in New York City and chair emeritus of dermatology. So, Mark, emeritus means you're pretty smart, right? So we'll have a good program. Mean, it's the first time I've been introduced as a powerhouse, but that's probably because I'm here in my sweatsuit lifting, you know, you're pumping up. So we're going to talk about actinocaratosis today, Mark, and obviously, I know you've been involved in research over the years. Everybody thinks about you with psoriasis and skin turnal medicine and that sort of thing. But you've done a lot, did a lot of teaching and publications on ectenocytosis. So how do you look at the landscape right now with where we are with field therapies? Because we obviously know we have targeted therapies and directed therapies like cryotherapy, which treats a lesion that we can see. But let's focus more on field therapies for actinocaritosis, how you integrate them and how you see the landscape. Sure. Let me say by way of introduction, even though psoriasis is my main area of research, probably the diagnosis I see most often is actinocaratosis. It's just incredibly common. And, in fact, decades ago, we were the first to treat actinocaratosis with Amikamod. It was one of my early publications, and I vividly remember I was actually the first patient to use it for an actinocaratosis on myself. And I told our dean at the time, who gave me permission to tell the story and use his name, but he know lots of actinocarotosis and many squamous cell carcinomas, and he would have multiple squamous cells a year. And he asked me for some samples. And back then at Mount Sinai, we could give out samples. We still actually can. We figured out how to do that. But I gave him some samples, and he calls me four weeks later and he know, I think you better take a look at that. And he was using it every day as I was as well. And it worked quickly. When you use it every day. But his whole scalp was one boggy, oozing crust and he did not get another squamousil or actinic for five years. And so we knew we were onto something. We then did a bilateral comparison trial, showed dramatic differences, and ultimately published a multicenter trial, which then led to approval for AKS. The pharmaceutical company that made it three m at the time had sales and its use for genital warts had sales of about, I think it was twelve and a half million dollars a year. A year after it got approved for aks, it was 250,000,000. So it was really a boon to them, but really a boon to our patients. Very good treatment for aks. We then published the New England Journal article on picato. Ever since then, we've had a major interest in aks. So you asked me about field therapies, and as you know, the most common field therapy used is not a field therapy, it's a treatment of individual lesions, and that's cryotherapy. And I don't think that it is just because it's reimbursed extra by Medicare. I think it's because it's easy. It's in everybody's office, it takes a few seconds and you focus on a single lesion so you don't have to warn the patient about some bad reaction they're going to get all over. The problem with field therapy is with individual lesion therapy, is that you are getting rid of that lesion temporarily. The recurrence rate is very high and the patient's going to crop up with a new AK right next to it. So I think my use of cryotherapy is perhaps a little more limited than most, but I use cryotherapy like everybody else does. The field therapies that we use are a couple of the ones we just mentioned. Picado is not available anymore because there are a number of reasons, but I think there was a somewhat unfair New England Journal of Medicine article which almost said it didn't work. Compared to Amicomod, PDT and five fu, the treatment used most widely, although not by much more than a Michel mod, is five fu. It's used twice a day, it's approved for four weeks and I use it for four weeks. If you use it for two weeks, you're not going to get as good a response. And what those patients have in common is an awful reaction. And when you get that awful reaction, the patients actually do well. The recurrence rate know, certainly in my experience, not what the New England Journal reported. But they cheated in that article because they allowed the patients to spot treat with cryotherapy and other treatments in the follow up period for that study. But the recurrence rates, in my view, are similar between five fluorior, amiquamod, which also gives a bad reaction. And the two have in common the amiquamod and the five fu, is that they go on for many weeks. So the patients are always kind of irritated and not doing well. Diclofenac, which has the brand name solarase, is much gentler. It's used twice a day for three months, but it's less effective. I think that PDT has a major advantage in that it's given once the patients get a bad reaction, which lasts a week or maybe a little longer than a week, but then that's gone and you're done with it. And it also has a very good response. Many of the people who use it repeat it several times a year to maintain that response. But it is a treatment I use often as well. And most recently we have turbinibulin, which is a treatment I really like because it is much less irritating than, for example, picado, or five fu, actually, than all of the treatments that we have, except diclofenac, which is very gentle but less effective. It has efficacy rates that are as good as any of the treatments I just mentioned, but with much less irritation. So the patients are over it in five days and are pretty happy with it. They use it, they apply it for five days. They have usually milder reactions because it's more of an effect on the apoptosis, not as much cytokine release and stimulating inflammation. I mean, we know with five fu being chemotherapeutic, you expect to get that reaction because of the mechanism, and it tends to be more painful than the other treatments. I agree with you. If you sure change, and there's data to show if they use it for less of a duration, they don't go the full four weeks, their response rate goes down. So I had a patient too, like yours, mark, that when I first saw him, he had such extensive involvement on his scalp with ectinocaratosis, had some thicker areas. I first was going to biopsy, thinking, oh, some of these might be SCC, incitu or something. Then I thought about it and said, what am I going to do with it? Anyway, there's no end to this. I treated them with the michelamod and he came back, and that time it was three times a week. I had him do it. He did it for about a month, and he had such a brisk reaction. It wasn't extremely painful. It was uncomfortable. But once he cleared, he didn't have anything for the few years after that that I saw him. So getting that reaction with a mikamot is helpful. It's just a lot for people to go through, and you have to have the downtime, especially if it's an exposed area. With tuberenobulin, the reactions are seen maybe after about seven days, and they're usually gone within one to two weeks, similar to ingen almebutate picado, which you mentioned. But I think Picado got some more brisk reactions than to Beolin. What's your feeling about that? Yeah, I'm actually giving a lecture on that, where we line up the phase three results of the two drugs. And, in fact, ingenl mebutate, which was a favorite drug of mine, I used it a lot, and the reason I liked it was you got it over with quickly. So a lot of my patients who work in public positions or some of them are on television or they interact with people every day, can't take six weeks off or four weeks off to go through imicomat or five fluorocyl. And so ingeal mebutate was a perfect drug for them. Turbinibulin has even less irritation than ingenl mebutate, and that comes across very clearly when you line up the local skin reactions from the two, phase three pivotal trials. It's a very well tolerated drug and a very effective drug. I've had patients who have been on all the treatments and clearly prefer that. And very recently, I had a patient who, because of the cost of it, asked to be given five fu. He came back to me and he said, I'm never going back to five fu. I'm going to spend the money on turbine abulin. That's another issue, by the way, because you go to one drugstore and it's $1,200, you go to another drugstore and it's $25. So it has some of the Medicare issues where they don't necessarily honor coupons unless the pharmacy has an arrangement with the company that makes it. A lot of the insurance companies don't want to pay for turbanibulin because they have not agreed to get a big discount or rebate. And the company instead makes it to a local pharmacy that will sell it at a huge discount. So specialty pharmacies in that situation, rather than randomly selecting a pharmacy. So, Mark, we're going to take a break at the moment. We're certainly going to get back to this because we're in the heat of the discussion for a word from our sponsor. We would like to thank Almeral for being today's sponsor. So, Mark, now we're at a very important part of our discussion is you get the prescription for the patient. I agree with you. Patients only have to apply the tobanobulin. It comes in the sachets. They could spread easily over the cosmetic unit or the anatomic unit that they're treating, the scalp, the know where the drug is FDA approved once a day for five days, and then they're done with what they have to actively do. And then they just ride it out, usually with not much visible. If it is, it's certainly less than what we see with five fu, typically with a micromod and even with ingenl mebutate. So the downtime is a lot less. But they have to be able to get it. And in my experience, if they just take the prescription, or nowadays we don't have a prescription pad, we have a suggestion that we make, right? We go through the EMR, and it's just randomly to a pharmacy that they want us to send it to. They're often going to run into problems with being told it's not covered, it's out of stock, it's $1,000 or $800 or whatever. But specialty pharmacies make a big difference, especially with access to the banibulin. So can you expound upon that? Because I know you've had some interesting experiences in the New York area. Yeah, I feel very strongly about it. I'll actually never have a patient. The patients will demand, oh, no, send it to my pharmacist. He's my friend. And what happens is the average pharmacist in the US gets a high proportion of their income as a payment from insurance companies to not prescribe medications. And the reason the insurance companies do that is they try to extort payoffs. And I'm not going to use the word discount to rebate. They call it discounts to rebates, but it's really payoffs from the pharmaceutical companies. And for a drug like turbineibulin, for example, they might ask for a payoff of over $1,000 when the drug costs $1,200. And so the pharmaceutical company is not going to agree to that. And instead, what they'll do is make an arrangement where they pay a certain amount of money to a local pharmacy in New York. We have something called Manhattan apothecary. There's another one called apotheco. There's a third one called AMA. And there are many pharmacies around the country that make their own arrangements directly with the pharmaceutical company, and they will always honor the prescription. So if the patient has the right insurance, and there are some Medicares that actually are the right insurance, so we're able to get it a lot of the time from Manhattan apothecary, which is the one I use. I don't have any financial conflict with them. But wherever you live, find that pharmacy. They almost always deliver. So even if my patient lives in, for example, New Jersey or Connecticut, which is miles away from Manhattan, they will deliver within a day to those patients, and they will charge the discounted price, which comes out to $25. So I send all my turbanibulin prescriptions through that particular pharmacy. And we have specialty pharmacies, a few that we use in the area. And we essentially say to the patient, if you're going to force it upon another pharmacy, you're likely not going to be able to get it. And I can't guarantee how quickly we're going to be able to get this resolved for you. It's going to sit on a pile of these kind of situations that just back up our office. So we encourage them. And I could rarely have had a patient been adamant about still send it to their pharmacy of choice. Once you explain it to them, sometimes the patients are looking at you as if you're getting some kind of kickback from it, and I make it clear that that is not the case. I want you to get the best medicine that I want for your situation, that you want also for your situation, and then it's not a problem. But people are suspicious of where the money is going nowadays, and I understand that they hear a lot of bad press out there about things that are going on. So now when you see the patient, you get them treated, and you're down the line. They come back six months later. How often might you repeat a therapy such as this for a patient, or does it depend on the patient? So it depends on the individual patients. So in the clinical trials, two things they did in the clinical trials, they brought patients back at day 57 to see how they were doing. That was their primary endpoint. And if you look at the graph, if you come back at two weeks, you get a reduction in aks. Come back at four weeks, you get more of a reduction in aks. So the day 57 was actually a very wise move. I actually bring my patients back often somewhere in there I might say, come back to me between six and eight weeks, because I'd like them to see that they are much better. And I find that a convenient time. If they have many aks left, then I will bring them back and do it again. You can get the medication refilled as often as once a month. So there's enough in there to treat the better part of a face. There's certainly enough in there to treat the whole scalp, even though in the clinical trials, they were limited to 25 cm². So it's five x five centimeter square, roughly. And I'll tell you why they came up with the five x five, because that was part of the original approval process for amiquamod, when the FDA viewed actinocaratosis as a very serious disease, and they considered one remaining actinocaratosis as a treatment failure because it was a precursor to a squamous cell carcinoma, which could be deadly. And there's actually data supporting that, that it is a precursor to a squamous cell carcinoma. In fact, Scott Denhardt published an article where he showed that metastatic squamous cell carcinomas, if you went back to the primary lesion, two thirds of the time, arose within actinocaritoses. So you can understand the FDA's point of view. Though I think it's flawed. If somebody had 100 aks and you got rid of 99 of them, that was a treatment failure. So in order to overcome the. Because it's unlikely that if someone has 100 aks, you will get rid of 100% of them. To overcome that, we created a scenario where you treated a five x five square centimeter box that had between six and eight aks. And so the chance of getting rid of eight aks now is much higher. And that's why these all come now in little packets, where you treat a small part of the face or scalp, but it turns out there's enough in there, if you spread it thinly, that you can treat a whole face or a whole scalp. When you say treat a small area, talking about the clinical trials, but the approval is to treat the entire. Like, if you're treating the forehead. Treat the entire forehead, right? Yeah. The dilemma is it comes in these packets. So unless you use more than one at a time, which is not approved, you're going to end up doing it five days in a row on a limited area. So often we'll treat the forehead and cheeks for a month, and then a month later, we'll treat the scalp. The same is true for the other therapies that we use, a Michamod five fu is more liberal because it was approved before these rules. So you can treat a large area. The same is true for PDT. The way the machine is constructed, we pretty much can only do face or scalp in one setting, and then a month later we do the other one. Yeah, I find with the packets that you get that each five day treatment session. You can treat that whole cosmetic area as long as the patient's not globbing it on a small area, and then you don't treat it every day for a month. With the branibulin, you're treating it for the five days, and then you see the patients back and you might have a couple of lesions left and you might just freeze those. Or certainly down the line. If patients that we have some patients that are constantly genetically programmed to keep reforming actinocaratosis, they can have another course of treatment when they need it. It's really a lifelong patient once they develop actinocaratosis, you agree? Yes. So I will say the average patient gets it once and then a year later we might give it to them again. There are some patients whom I've done twice a year. I had one patient on a Michelmat who I have not seen since the pandemic, and when he comes back to me, I will be switching him to turbinabulin and have him do the five day thing. And he has actinix all over his arms, all over his legs, all over his face and scalp. And basically we treat one body site at a time and rotate the body sites, and he's done actually very well with that. That's good. Well, Mark, thanks so much for your time today. I know you're busy, I know how busy you are. So we really appreciate your time. Thank you very much. Thanks for having me. Thank you for listening to this episode of Derms and conditions. If you have any questions or comments, please email us at. Podcasts at Fred Health and most importantly, if you like this episode code, subscribe to the Derms and Conditions podcast on Apple Podcasts or wherever you get your favorite shows. Thanks for joining us. We would like to thank Almarol for sponsoring today's episode.

In Episode 8 of&nbsp;Derms and Conditions, our host James Del Rosso, DO speaks with Neal Bhatia, MD regarding barriers to sunscreen use and offers tips on how to counsel patients on sunscreen use and photoprotection.

In Episode 8 of Derms and Conditions, our host James Del Rosso, DO speaks with Neal Bhatia, MD regarding barriers to sunscreen use and offers tips on how to counsel patients on sunscreen use and photoprotection.Dr. Del Rosso and Dr. Bhatia also discuss the optimal use of photodynamic therapy for actinic keratoses, both pre-procedural and post-procedure. Finally, Dr. Del Rosso poses an intriguing question and Dr. Bhatia shares a very important clinical pearl for management of dermatological issues in the Emergency Room. Financial Disclosures James Del Rosso, DO CONSULTANT/ADVISOR Abbvie, Aclaris, Almirall, Amgen, Arcutis, Bausch Health (Ortho Dermatology), BioFrontera, BioPharmX, Bristol-Myers-Squibb, Cassiopea, Dermata, Dermavant, Encore, EPI Health, Evommune, Ferndale, Galderma, Incyte, JEM Health, Leo Pharma, La Roche Posay, Lilly (Dermira), MC2, Novan, Pfizer, Regeneron, Sanofi-Genzyme, SolGel, Sonoma (IntraDerm), Sun Pharma, Trevi, UCB, Verrica, Vyne (Foamix; Menlo) SPEAKER BUREAU Aclaris, Almirall, Amgen, Arcutis, Bausch Health (Ortho Dermatology), EPI Health, Ferndale, Galderma, Genentech, JEM Health, Leo Pharma, La Roche Posay, Lilly (Dermira), Pfizer, Regeneron, Sanofi-Genzyme, Sun Pharma, UCB, Verrica, Vyne (Foamix; Menlo) RESEARCH INVESTIGATOR Aclaris, Almirall, Amgen, Anaptys Bio, Arcutis, Athenex, Bausch Health (Ortho Dermatology), BioPharmX, Biorasi, Botanix, Brickell, Cara Therapeutics, Cassiopea, Dermavant, EPI Health, Ferndale, Galderma, Incyte, Leo Pharma, Lilly (Dermira), Novan, Pfizer, Ralexar, Regeneron, SolGel, Sun Pharma, UCB, Verrica, Vyne (Foamix; Menlo). Neal Bhatia, MD Advisory Board: Abbvie, Almirall, Biofrontera, BMS, BI, EPI Health, Ferndale, Foamix, Galderma, InCyte, ISDIN, J&amp;J, LaRoche-Posay, Leo, Lilly, Ortho, Pfizer, P&amp;G, Regeneron, Sanofi, SunPharma, Vyne, and Vyome Research: Abbvie, Almirall, Biofrontera, BMS, BI, EPI Health, Ferndale, Foamix, Galderma, InCyte, ISDIN, J&amp;J, LaRoche-Posay, Leo, Lilly, Ortho, Pfizer, P&amp;G, Regeneron, Sanofi, SunPharma, Vyne, and Vyome Speakers' Bureau: Abbvie, Almirall, Biofrontera, BMS, BI, EPI Health, Ferndale, Foamix, Galderma, InCyte, ISDIN, J&amp;J, LaRoche-Posay, Leo, Lilly, Ortho, Pfizer, P&amp;G, Regeneron, Sanofi, SunPharma, Vyne, and Vyome

Fun in the Sun: Tips for Counseling Patients on Sunscreen and Treatment Tips for Photodynamic Therapy

What are the practical advantages of prescribing the 350 mg packet of tirbanibulin over the 250 mg?

What advancements in the understanding of actinic keratosis pathophysiology or treatment are shaping future management approaches?

How can dermatologists decide between lesion-directed and field-directed therapies when treating actinic keratosis?

What is the estimated risk of progression from actinic keratosis to squamous cell carcinoma, and how does lesion count affect this risk?

What were the key findings of the PROAK study, and how did its results inform our understanding of tirbanibulin’s impact on patient quality of life?

How do you advise scheduling follow-up visits for patients on tirbanibulin, knowing pivotal trial endpoints extended to 57 days?

How do you approach field therapy in actinic keratosis, and where does tirbanibulin fit into that strategy?

When might you choose tirbanibulin over 5-FU for AK field therapy?

How do you counsel patients and colleagues about the timeline of response, given that visible skin reaction may not appear immediately?

In terms of a clearance timeline, what expectations should clinicians set with themselves and with patients starting tirbanibulin, especially when comparing it with therapies like 5-FU?

Efficiently Implementing Photodynamic Therapy (PDT) for Actinic Keratosis (AK) in Dermatology Practices

In this episode of Business Unblemished, Dr Dawn Merritt and Dr Aaron Farberg discuss how to efficiently implement photodynamic therapy (PDT) for actinic keratosis (AK) in dermatology practices. They address common misconceptions about PDT’s cost, logistical challenges, and practical strategies to maximize both its clinical and financial value.Why use PDT for actinic keratosis?PDT is an effective field therapy for actinic keratosis. While individual lesions can be treated with cryotherapy, many patients require broader treatment, making PDT an excellent in-office option.Dr Merritt, an early adopter of PDT, has integrated the treatment into all 10 of her practice locations, where it is performed daily. Dr Farberg strongly believes every dermatology practice should offer PDT, noting that dermatologists are likely to see multiple patients every day who could benefit from it. While topical therapies remain a viable and effective option, PDT offers greater control over treatment application and adherence, ensuring patients receive consistent and effective care.Optimizing workflow and staffingDr Merritt emphasizes that proper scheduling is key to ensuring PDT does not disrupt clinic flow. Instead of scheduling PDT as a physician-led appointment, she recommends setting it up as a nurse visit:<ul><li>Medical assistants (MAs) handle the setup and patient preparation</li><li>The physician only needs to be present for consent, curettage, and product application, allowing them to continue seeing other patients while the PDT session runs in the background</li></ul>Dr Farberg adds that while MAs can manage most of the process, physicians should personally apply and initiate PDT for optimal reimbursement and quality of care. A simple way to improve efficiency is to provide patients with a bell to call for assistance while MAs manage other tasks such as prior authorizations or patient paperwork.Space considerations for PDT implementationOne common concern among dermatologists considering PDT is space requirements. However, PDT does not require a dedicated room:<ul><li>Dr Merritt recommends using a nurse visit room or an overflow exam room to allow smooth patient flow</li><li>Dr Farberg has successfully implemented PDT in small rooms, demonstrating that space limitations should not deter practices from considering the service</li></ul>Addressing cost concerns and maximizing revenueFor newer or smaller practices, the upfront cost of PDT equipment may feel like a barrier. However, both doctors emphasize that PDT is a long-term revenue generator:<ul><li>Established practices can confidently invest, knowing they will recoup costs over time</li><li>New practices with tighter budgets can explore equipment rental options, which allow them to offer PDT without large upfront costs</li></ul>Dr Merritt routinely budgets for PDT when opening a new office because she knows its profitability and value to patients.Educating patients about PDTDr Merritt emphasizes that patient education is crucial for successful PDT integration. She advises new practices to:<ul><li>Create a simple handout explaining what patients can expect</li><li>Always schedule 2 PDT treatments upfront, with a third follow-up visit 8 weeks later for evaluation.</li></ul>Dr Farberg finds that offering multiple field therapy options allows patients to choose what works best for them, though many prefer PDT due to its ease of use and convenience.Training staff to promote PDTDr Merritt utilizes rolling screen advertisements in her offices to inform patients about PDT before their appointment. Additionally, she has trained her MAs with instructional videos that cover:<ul><li>PDT setup and application</li><li>How to explain the procedure to patients</li><li>When to involve the physician during treatment</li></ul>This structured approach ensures the entire team is aligned and helps patients feel more comfortable with the procedure.Identifying ideal candidates for PDTDr Merritt has a simple rule of thumb for determining when to recommend PDT:<ul><li>If she has to freeze more than what fits on one hand, the patient needs field therapy—and PDT is her first choice</li></ul>Dr Farberg also sees PDT as a built-in marketing tool; patients who receive it often remark that they have never had it offered at other dermatology offices. These patients share their positive experiences with friends, bringing in new patients and strengthening practice growth.PDT remains one of the most effective and well-established treatments for AK field therapy. While some dermatologists hesitate due to logistical concerns, both Dr Merritt and Dr Farberg emphasize that with proper implementation, PDT can enhance patient care while becoming a valuable revenue stream.Key takeaways<ul><li>PDT offers precise, in-office field therapy for patients with AK</li><li>With efficient scheduling, PDT can be integrated seamlessly into any practice workflow</li><li>Space constraints should not deter practices from offering PDT</li><li>The cost of PDT equipment is quickly recouped, and rental options are available</li><li>A well-trained team and patient education help maximize PDT’s impact</li></ul>

With tirbanibulin ointment now approved for treating a larger surface area up to 100 cm², how does this improve treatment flexibility for patients and providers?

Can tirbanibulin ointment be safely and effectively used for actinic keratosis on the full face?

How does the safety of tirbanibulin ointment when treating larger surface areas compare to the safety observed in the original clinical trials?

Are skin reactions common with tirbanibulin ointment, and when do they typically peak?

What strategies can dermatologists use to manage common side effects associated with tirbanibulin ointment?

How does tirbanibulin ointment's efficacy compare with other field-directed therapies for actinic keratosis?

What is the recommended dosing regimen for tirbanibulin ointment, and how does it differ from other field therapies?

What are the key risk factors for developing actinic keratosis, and how can dermatologists identify high-risk patients?

Why is it important to address actinic keratosis as a chronic condition rather than isolated lesions?

What are the most effective strategies for preventing actinic keratosis in at-risk populations?

Expanding Treatment Options for Actinic Keratosis: Tirbanibulin 

In this episode of Topical Conversations, Neal Bhatia, MD, and Naiem Issa, MD, discuss the use of tirbanibulin (Klisyri) for actinic keratosis (AK), including its expanded indication for broader application areas. The FDA’s expanded approval in June 2024 allows tirbanibulin to be used over surface areas up to 100 cm², offering dermatologists a more versatile approach to treating larger areas on the face or scalp.&nbsp;FDA approval for larger surface area treatment&nbsp;Initially approved in 2020 for application on small areas up to 25 cm², tirbanibulin's expanded indication provides flexibility for dermatologists managing AK. With 2 packaging sizes—a 250-mg dose for up to 25 cm² and a new 350-mg package for up to 100 cm²—clinicians can select the appropriate dose to treat larger surface areas effectively.&nbsp;A practical application technique: the “windshield wiper” approach&nbsp;To maximize coverage and effectiveness, Dr Bhatia recommends a straightforward method he calls the “windshield wiper” approach, instructing patients to apply tirbanibulin from temple to temple, across the forehead, and including the nose and ears. This application technique ensures comprehensive treatment over larger areas, essential for patients with diffuse AK.&nbsp;Mechanism of action: apoptosis vs necrosis&nbsp;One of the unique aspects of tirbanibulin is its apoptotic mechanism, which selectively induces cell death in abnormal cells, sparing surrounding healthy tissue. Unlike traditional AK treatments that cause necrosis and associated discomfort, tirbanibulin’s pathway results in fewer inflammatory skin reactions. This distinction makes it an attractive option for dermatologists looking to offer a gentler but effective alternative to patients with AK, who often experience visible irritation with standard therapies.&nbsp;A sequential approach to AK treatment&nbsp;Dr Bhatia shared his protocol for AK management, combining multiple therapeutic approaches to target both visible lesions and subclinical precursors. His approach involves initially using cryotherapy to address active lesions, followed by a course of tirbanibulin after one to 2 weeks, and potentially incorporating photodynamic therapy (PDT) within a few months. This holistic strategy can help provide comprehensive control over AK, addressing both current lesions and preexisting, yet undetectable, cells.&nbsp;For dermatologists without access to PDT, Dr Issa recommends a segmented approach. He suggests starting with one facial area (eg, temple-to-temple) and then evaluating results after 3 to 4 months. Patients can then treat additional sections over time, minimizing the burden of treating an entire facial area at once.&nbsp;Patient counseling and setting realistic expectations&nbsp;Setting expectations is crucial for successful tirbanibulin treatment. Dr Bhatia encourages dermatologists to advise patients that tirbanibulin’s effects are generally noticeable around days 8 to 15. To help patients understand the process, he likens the experience to a slightly turbulent flight that ultimately results in a smooth landing.&nbsp;Patients often appreciate tirbanibulin’s 5-day treatment protocol, especially when compared to longer regimens required by other AK treatments such as diclofenac or imiquimod. This shorter treatment period increases adherence and may reduce the need for frequent follow-up appointments.&nbsp;Ongoing maintenance: encouraging long-term care for AK&nbsp;Both Dr Issa and Dr Bhatia emphasized the importance of educating patients on the need for periodic AK maintenance. Dr Issa noted that encouraging patients to treat one facial area, then reassessing after several months, fosters a consistent approach to ongoing AK care.&nbsp;Key benefits of tirbanibulin for dermatologists and patients&nbsp;With its unique apoptotic mechanism, flexible dosing options, and shorter treatment duration, tirbanibulin has emerged as a valuable addition to the AK treatment landscape. Dr Bhatia concluded that tirbanibulin’s mild side effect profile, relative safety, and potential for high patient satisfaction make it an underutilized tool with promise for dermatologists. He encouraged documenting patient experiences to support reimbursement, which could enhance accessibility and adherence to tirbanibulin as part of an ongoing AK management plan.

Real World Approaches to Actinic Keratosis 

In this session, Brian Berman, MD, PhD, and Darrell Rigel, MD, MS, provided an overview of available therapies for actinic keratoses (AKs), emphasizing combination therapies and delivering individualized patient care. Patients with AK have a 1.9 times higher risk of developing cutaneous squamous cell carcinoma (cSCC) each year and an 11.4% greater cumulative incidence compared to those without AKs, highlighting the importance of having an array of treatments to reduce cSCC risk. There are treatment options available, which are discussed in the lecture, including cryotherapy, tirbanibulin, 5-fluorouracil (5-FU), imiquimod, diclofenac, and photodynamic therapy (PDT).&nbsp;The American Academy of Dermatology guideline efficacy reports of tirbanibulin, imiquimod, 5-FU, and diclofenac indicated that imiquimod and 5-FU had the highest efficacy rates with 80% partial and 52% to 54% complete clearance rates. Tirbanibulin, which was a close third, was recently FDA approved for field treatment of 100 cm2 with similar efficacy and safety compared to its previous FDA approval for 25 cm2 treatment areas.&nbsp;The presenters explored optimal treatment regimens for AK treatment with PDT. Combining aminolevulinic acid (ALA) with PDT significantly enhances PDT efficacy compared to PDT monotherapy, however treatment is known to be painful. The presentation highlighted alternative methods to improve patient comfort during PDT by using "short contact ALA." This modified regimen, where ALA is applied followed by immediate blue light PDT, was found to be equally effective and significantly less painful.&nbsp;Given the risk of AK progression to cSCC, the presenters underscored the need for patient-tailored therapy and integration of both lesion-targeted and field-directed treatments. When used first, lesion-directed therapy first reduces AK burden prior to field therapy, but topical field therapy may identify subclinical lesions prior to more targeted therapy. Dermatologists should consider the benefits and drawbacks of the order in which lesion and field-directed treatments are applied.

What's New and Hot with PDT Therapy

Roger Ceilley, MD took us through a riveting review of the innovations in photodynamic therapy but not before completing an overview of its mechanism of action and some industry updates for clinical practice. Notably, a new red light laser (635nm) has garnered FDA approval with a flexible multipanel lamp for full face coverage, and CPT codes strictly dictate clinician involvement in PDT procedure: 96567 for no direct participation, 96573 for clinicians applying photosensitizer and initiating light illumination, and 96574 for the performance of curettage or debridement prior to PDT.&nbsp; He emphasized the importance of setting expectations, especially surrounding one of the major disadvantages of PDT which is the discomfort and erythema that remains post-procedure. &nbsp;While compliance with PDT remains much higher than that for topicals in the treatment of actinic keratoses, Dr. Ceilley proposed multiple methods to mediate patient discomfort. One split-face study that compared blue light PDT with two photosensitizers, 10% ALA-gel and 20% ALA solution, demonstrated that the gel formulation was associated with significantly less local skin reactions. Other options to mitigate pain include fans, cold compresses, antihistamines, and topical or local anesthesia, though modifications to the actual treatment regimen, i.e. shorter incubation times or lower irradiance, may be the most effective. Even immediate irradiance, “simultaneous PDT”, for 30 – 60 minutes after application of ALA could be a promising option to dramatically lower pain scores while maintaining almost identical clearance rates to conventional PDT in another, albeit small (n=23), split-face study.&nbsp; Moving on to treating the extremities and trunk, Dr. Ceilley showed that efficacy can be increased with the addition of occlusion dressing during the incubation period or with pretreatment of adapalene for 7 days in two RCT trials. Microneedling prior to treatment with ALA appeared to have less dramatic results, with improved AK clearance after 20-minute incubation but not for 10-minute incubation. While simultaneous PDT may be effective for the face, he recommended sticking to an incubation time of at least 2-3 hours for the extremities. Other tricks to increase efficacy of PDT include adding cryotherapy before incubation and warming the extremities before irradiance, called “thermal” PDT. New frontiers include the use of PDT for alternative conditions like photodamage, which has already shown promising results, inflammatory conditions like acne and psoriasis, and cutaneous T-cell lymphoma.

Is there data on using calcipotriene cream vs ointment in combination with 5-FU and does the order of application matter?

You. One of the ways to augment the activity of five Fu is the addition of calciupatrine, and a cream or a foam version of calcipatrine is readily available. These have been used pretty routinely now in healthcare systems such as Kaiser and hmos and there's basically a four day scheme looking at three months out. As far as an assessment, we're still looking for larger trials for anything pivotal as well as long term efficacy and recurrence data. I think it's an easy regimen to apply. There is a lot of irritation when you add the calcium petrine, either in ointment or cream foam to the already irritating five Fu. But enhancing its efficacy by increasing the activity of TSLP as an antigen as well as improving the epidermal turnover and changing differentiation are all really important consequences of using the two together. I think it allows for a good regimen as well as activity on service area. The real questions again come from long term recurrence frequency of cycles as well as the use in combinations. There was a nice trial. Dr. Angela Moore and her group did a foam study with calcipitrine foam mixed with five fu and showed some utility with cryotherapy, which I think is a really good way of applying it in a real world setting.

Any reservations about using tirbanibulin ointment for actinic cheilitis?

You. There have been questions about the use of tirbanibulin ointment for the treatment of actinic cheilitis, even though it's again off label. The use for actinic kerotosis in 25 cm² is its true indication, but the reality of the ointment base, as well as the activity of tirbanibulin and its impact on the process of actinic cheilitis lends itself well. There's also very little in terms of local skin reactions, which allows it to possibly be more tolerable around the lips. I would have no problem using it, maybe with a little occlusion from aquaphor or vaseline over the lips, doing it daily for five days and assessment probably 29 days later, being cognizant of having to take biopsies, possibly to determine the diagnosis of actinic cheilitis, as well as exclude any squams that might be growing in the area. But I think the use of tirbanibulin ointment as treatment for actinic cheilitis is actually very impressive. It also, again, given some of the alternatives that have not done well with actinic cheilitis or have been intolerable, I think we may have something that might be a useful adjunct or at least an alternative to some of the more ablative treatments of the lips and reducing the need for surgery.

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