Warts And Molluscum

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</div>Watch as Dr James Q Del Rosso discusses the clinical significance of berdazimer topical gel, 10.3%, for molluscum contagiosum, including application details, efficacy, and safetyLigand Pharmaceuticals Incorporated has achieved a groundbreaking milestone with the recent approval of ZELSUVMI™ (berdazimer topical gel, 10.3%) by the US Food and Drug Administration (FDA). This marks a significant advancement in the treatment of molluscum contagiosum in adult and pediatric patients aged one year and older.&nbsp;A novel approach to molluscum treatmentZELSUVMI is the first and only topical prescription medication that can be applied by patients, parents, or caregivers outside of a medical setting for the treatment of molluscum contagiosum.&nbsp;Together with <a target="_blank" rel="noopener noreferrer" href="https://dermsquared.com/news-research/launch-alert-fda-approves-ycanth-for-molluscum-contagiosum">the July 2023 approval of YCANTH</a> (cantharidin topical solution 0.7%), ZELSUVMI has significantly expanded the therapeutic options available for molluscum.&nbsp;ZELSUVMI is a nitric oxide releasing agent. Nitric oxide has been shown to have antiviral properties, but the mechanism of action of ZELSUVMI for the treatment of molluscum contagiosum is unknown.&nbsp;Clinical trial insightsFDA appproval is supported by results from the 12-week pivotal Phase 3 trial B-SIMPLE4, in which 891 patients with a mean age of 6.6 years (range, 0.9-47.5 years) were randomly assigned to treatment with berdazimer gel 10.3% or a vehicle gel applied in a thin layer to all lesions once daily. At 12 weeks, 32.4% of patients in the berdazimer group achieved complete clearance of molluscum lesions compared with 19.7% of those in the vehicle group (P &lt; .001).&nbsp;Safety profileCommon adverse reactions reported included application site reactions such as burning or stinging sensations (18.7%), erythema (11.7%), pruritus (5.7%), exfoliation (5.0%), dermatitis (4.9%), swelling (3.5%), erosion (1.6%), discoloration (1.5%), vesicles (1.5%), irritation (1.2%), and infection (1.1%).&nbsp;Only 4.1% of patients on berdazimer gel 10.3% and 0.7% of those on the vehicle experienced adverse events that led to discontinuation of treatment.&nbsp;Future outlookZELSUVMI is anticipated to be available in the United States in the second half of 2024, bringing a new level of convenience and effectiveness to the treatment of molluscum contagiosum. This FDA approval marks a significant stride forward in the treatment of molluscum, offering patients and caregivers a user-friendly alternative for managing this condition.

The groundbreaking treatment is the first-and-only topical prescription medication for molluscum that can be applied outside of a medical setting

LAUNCH ALERT: Berdazimer Topical Gel 10.3% (ZELSUVMI) Receives FDA Approval for Treatment of Molluscum Contagiosum in Adult and Pediatric Patients 

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</div>Watch here as James Del Rosso, DO, discusses the unique features of YCANTH, explains the application process, and remarks on the benefits and importance of this first-ever FDA-approved treatment for molluscum contagiosum.&nbsp;Verrica Pharmaceuticals has announced the launch of YCANTH, the first and only FDA-approved treatment for molluscum contagiosum in adult and pediatric patients 2 years and older.YCANTH is a drug-device combination product containing a GMP-controlled formulation of cantharidin (0.7% w/v). YCANTH is delivered via a single-use applicator and applied directly to lesions with a specialized applicator tip, allowing for precise topical administration.&nbsp;FDA approval was issued after positive outcomes from the CAMP-1 and CAMP-2 trials, which assessed the safety and effectiveness of VP-102 (YCANTH) in patients 2 years and older who were diagnosed with molluscum contagiosum. In the identical phase 3 randomized, double-blind, multicenter trials, a clinically and statistically significant number of patients treated with VP-102 achieved the primary endpoint, which was complete clearance of all treatable lesions.&nbsp;In CAMP-1, 46% of participants receiving VP-102 achieved complete clearance of molluscum lesions versus 18% in the placebo group. Similarly, in CAMP-2, 54% of participants receiving VP-102 achieved complete clearance compared with 13% in the placebo group.&nbsp;No serious adverse reactions were reported in the trials. The most common mild-to-moderate adverse reactions (incidence ≥1%) reported were vesicles, pain, pruritus, scab, erythema, discoloration, dryness, edema, erosion, and contact dermatitis.&nbsp;Verrica plans to make YCANTH available commercially in September 2023.

The groundbreaking topical solution addresses one of dermatology’s greatest unmet needs

LAUNCH ALERT: FDA Approves YCANTH for Molluscum Contagiosum

MONDAY, June 5, 2023 (HealthDay News) -- Patients may be tempted to treat little skin bumps on their own, but that can delay proper diagnosis and treatment that may work better, federal regulators caution.Products marketed as treatments for molluscum have not been approved by the U.S. Food and Drug Administration, the agency warned. There are no approved treatments in either prescription or over-the-counter form for the condition, which will typically go away on its own in six to 12 months but could last up to five years.Molluscum can grow alone or in groups almost anywhere on the skin, including the face, neck, arms, legs, abdomen, and genital area. They are rarely on the palms of the hands or soles of the feet. Sometimes these bumps itch and get irritated. Patients with a weakened immune system may have larger or more bumps. They are more common in children, but can happen in teens and adults.Molluscum is spread by skin-to-skin contact, including sexual contact, and by sharing clothes or infected objects such as sports equipment. Staying clean, including hand washing, is the best way to prevent them.Unapproved products are unlikely to actually have the impact they claim and may cause bad reactions, such as skin reddening, abrasion from skin scratching, and permanent scarring. It is also possible to have an allergic reaction to products, such as those that contain essential oils.

Unapproved products are unlikely to actually have the impact they claim and may cause bad reactions

FDA Warns Against Using Bogus Treatments for Molluscum

Needle-free injection of 5-fluorouracil (5-FU) is effective for the treatment of palmoplantar warts, according to a research letter published online on Nov. 29 in the
 
 Journal of the American Academy of Dermatology
 
 .




 Yue Wu, from Zhongda Hospital in Nanjing, China, and colleagues conducted a randomized clinical trial to explore the efficacy and safety of needle-free injection of 5-FU versus cryosurgery therapy for treating palmoplantar warts. Seventy-six patients aged 10 to 75 years with palmoplantar warts were randomly assigned to receive a maximum of three sessions of needle-free injection of 5-FU or cryotherapy every three to four weeks. Patients in the needle-free group received intralesional injections of 5-FU with an injector; a mixture of 5-FU and lidocaine was injected vertically into each wart. Liquid nitrogen was applied with a spray to participants in the cryotherapy group.




 The researchers found that 63.16 percent of patients in the needle-free injection group showed complete response (CR), 26.32 percent showed partial response (PR), and 10.53 percent showed no response (NR). In the cryosurgery group, 21.05, 63.16, and 15.79 percent had CR, PR, and NR, respectively. The visual analog scale of the needle-free injection group varied from 1 to 7, with a median of 3, while the median was 6.5 for cryotherapy. Neither group reported serious adverse effects.




 "Our study suggested that needle-free injection of 5-FU was a promising therapy, especially for patients who were pain-averse and needle-phobic," the authors write.




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More patients in 5-FU versus cryotherapy group had complete response to treatment, and median VAS was lower

Is Needle-Free Injection of 5-FU Effective for Palmoplantar Warts?

Use of berdazimer gel seems efficacious and safe for treatment of molluscum contagiosum (MC), according to a study published online July 13 in
 
 JAMA Dermatology
 
 .




 John C. Browning, M.D., from Texas Dermatology and Laser Specialists in San Antonio, and colleagues conducted a phase 3 randomized clinical trial in 55 clinics in the United States to examine the efficacy and safety of berdazimer gel, 10.3 percent, for treatment of MC. Eligible participants, aged 6 months or older and with three to 70 raised MC lesions, were randomly assigned to either berdazimer gel or vehicle gel (444 and 447 participants, respectively), applied to all lesions as a thin layer once daily for 12 weeks.




 The researchers found that at week 12, 32.4 and 19.7 percent of patients in the berdazimer and vehicle groups, respectively, achieved complete clearance of MC lesions (odds ratio, 2.0), with 14.4 and 8.9 percent of those receiving berdazimer and vehicle, respectively, discontinuing treatment due to MC clearance. Application-site pain and erythema were the most common adverse events and were mostly mild in severity. Overall, 4.1 and 0.7 percent of patients in the berdazimer and vehicle groups, respectively, had adverse events leading to discontinuation.




 "Berdazimer is under consideration as a first-in-class therapeutic agent for MC and may provide a topical prescription alternative to other therapies used for this highly contagious and psychosocially challenging skin condition," the authors write.




 Several authors disclosed financial ties to Novan, which manufactures berdazimer and funded the study.




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Odds of complete clearance of MC lesions increased for patients receiving berdazimer gel 10.3 percent versus vehicle for 12 weeks

Berdazimer Gel Efficacious, Safe for Molluscum Contagiosum

The estimated annual costs were $846 million for cutaneous warts for 2019 in the United States, and costs for anogenital warts were $127 million, according to a research letter published online April 27 in
 
 JAMA Dermatology
 
 .




 Ronald Berna, from the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, and colleagues evaluated annual health care utilization and costs associated with common cutaneous and anogenital wart treatments in a retrospective cohort study using the deidentified Optum Clinformatics Database.




 On average, for each year from 2017 through 2019, 263,070 individuals with cutaneous warts (mean age, 44 years; 52 percent female) and 28,516 with anogenital warts (mean age, 43 years; 40.7 percent female) were captured. The researchers found that 64.2, 1.8, and 2.2 percent of individuals with cutaneous warts were treated with lesional destruction, intralesional injection, and prescription topical medications, respectively. For anogenital warts, 35.3, 0.6, and 16.5 percent were treated with lesional destruction, intralesional injection, and prescription topical medications, respectively. For 2019, the annual costs were estimated at $846 million and $127 million for cutaneous and anogenital warts, respectively. The per-patient costs were estimated at $288.28 and $431.47 for cutaneous and anogenital warts, respectively.




 "Understanding health care utilization for warts provides useful information for anticipatory guidance (e.g., expected number of treatments) and insight into the burden of disease," the authors write.




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Per-patient costs for evaluation and management estimated at $288.28 for cutaneous warts and $431.47 for anogenital warts in 2019

Annual Costs Estimated for Wart Treatment in the U.S. for 2015-2017

For patients with molluscum contagiosum (MC), topical berdazimer gel 10.3 percent is associated with a significant reduction in lesion count by four weeks, according to a study presented at the annual meeting of the American Academy of Dermatology, held from March 25 to 29 in Boston.




 John C. Browning, M.D., from Texas Dermatology in San Antonio, and colleagues conducted a multicenter, randomized, vehicle-controlled trial to examine the efficacy and safety of berdazimer 10.3 percent for the treatment of MC in 891 participants. A total of 447 and 444 patients with three to 70 raised and palpable molluscum lesions were randomly assigned to vehicle or berdazimer, respectively, for 12 weeks.




 The researchers found that significantly more patients receiving berdazimer had complete clearance of all lesions by week 4 (7.2 versus 3.6 percent), week 8 (19.6 versus 11.6 percent), and week 12 (32.4 versus 19.7 percent). At least one treatment-emergent adverse event (TEAE) occurred in 23.0 and 43.0 percent of patients receiving vehicle and berdazimer, respectively; 0.7 and 4.1 percent of patients, respectively, had at least one TEAE leading to study drug discontinuation. Application site pain and erythema were the most common TEAEs; pain was mostly transient. Erythema was the most frequent local skin reaction and occurred more often in berdazimer-treated patients.




 "In B-SIMPLE4, berdazimer 10.3 percent once-daily treatment, MC showed lesion count reduction by four weeks, with continuous improvement over time," the authors write.




 Several authors disclosed financial ties to Novan, which manufactures berdazimer and funded the study.




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Lesion reduction seen by week 4, with continuous improvement over time; treatment-emergent adverse events mainly mild

AAD: Berdazimer Gel Clears Molluscum Contagiosum Lesions

On what areas of the body can cantharidin be applied?

Ketherin is very useful, except for probably areas around the intraturgenous or maybe the axillary distribution as well as the genitals sometimes, because the blistering can be a little bit unpredictable with Catherine, you have to be sure that the vesicle or the blister that comes from it is sometimes managed with a little bit of topical anesthesia or something else that could be uncomfortable for the patient. But for the most part, aside from the head and neck, genitals and the axillary areas, we pretty much use cantheridin pretty liberally, and it's not really been much of a problem.

How is cantharidin applied?

You. Historically, we've been using the wooden end of a cotton swab or qtip applicator to apply the canheridin from a bottle, which has led to inaccurate delivery. With the precision applicator, we have a more active and more direct way of applying the canheridin to the spots, which is obviously going to help not only the innocent skin, but to deliver the active ingredient to the spots themselves, which would be better for the outcome.

What is the mechanism of action for cantharidin?

So canteridin comes from beetlejuice. Historically, it's been a common joke, if you will. The patients even say, well, is this the beetlejuice drug? But the mechanism is to separate the dermal epidermal junction, create a vesicle that will separate the Molescan bodies, as well as anything that's varucos, and create a turnover that will allow for lesion reduction, as well as the implosion, if you will, of the wart or the Molescan body that will create the healing of the lesion.

Can you reuse the cantharidin applicator?

You with the precision applicator. It's a little bit more precise, if you will. No pun intended. To actually get to the spots. We try not to reuse the area in risk of contagion as well as risk of secondary infection of reapplication. The goal is to apply once and then dispose of the applicator and then use the next one at the next treatment.

Why is denatonium benzoate included in the ingredient list for cantharidin?

Denitin benzoate is actually a deterrent for patients to ingest or taste the medication, if you will. We try to keep it away from patients mouths or have them go away from their fingers. But in case it does get into that area around the oral mucosa, it's immediately discarded because of the bad taste.

What are some important instructions you should give to give patients being treated with cantharidin?

You. Patients being treated with canteridin should be advised that the vesicle or the blister is an anticipated local skin reaction that is part of the mechanism of action. They should be aware that if it does become painful or itchy, we can use some other things as emollients or anti itch ingredients to mitigate those responses. But that is actually what we're looking for in terms of the treatment, to obviously get rid of the molescam or the wart or whatever we're treating.

Why are patients with atopic dermatitis more at risk of contracting molluscum contagiosum?

You. So we advise patients with atopic dermatitis to be aware of molluscan contagios and papules because the pox virus finds its way into the examinous areas and that defective barrier a little bit more rapidly to create the spots. And there's a little bit extra risk in terms of that barrier, as well as that disruptive skin to develop mollusca, which can spread very quickly in those examinous plaques.

What are some complications and long-term effects associated with molluscum contagiosum?

You. Aside from the spread and the contagion of molescom, the obvious defect that comes from the barrier could create some scarring as well as a lot of excoriation. That would lead to more spread of this papules. Even more so, the long term consequence could lead to more scarring as well as more potential for those patients to become isolated.

What are some of the biggest challenges in treating molluscum contagiosum?

You. Over the last few decades, Moscow Contagiosum hasn't had a dedicated treatment. We've tried multiple modalities that have been either painful or ineffective, or either creating more expense or even worse is the concept that the Moscow spots would even go away, which is what pediatricians or some dermatologists actually tell the patients, which unfortunately, is not the case. So over the years, we've tried to develop treatments or have treatments such as canteridin that would actually help the process. Now, with the ability to use it more precisely and deliver the medication more actively, we can actually get to the scene of the crime and improve the outcomes for those molesting patients.

Which patients are eligible for treatment with cantharidin, and are there any notable exclusions?

You. What's really exciting is that both studies, camp one and camp two, involved pediatric patients. As a pediatric dermatologist, this is wonderful to know that they study patients as young as two years of age and into adulthood. The majority of the patients in the study is primarily a pediatric study, enrolled patients as young as two years, up to 17 years, and there were adults also in the study. But again, primarily, if you round up, about 90% of the subjects enrolled in both camp one and camp two studies were of young age.

What are some of the most common adverse reactions associated with cantharidin?

White anth, as many of you know, is a vesicin agent, and therefore blistering is a potential adverse event that we see just from the medication use on its own. With any clinical trial we do investigate and we study any unwanted adverse events such as blistering, but also pain and itch and discomfort at the treated site. So those are other potential adverse events that could be seen. What we did not see is significant scarring in the study and for the patients that were enrolled with higher Fitzpatrick types in skin of color, there was not an increased amount of adverse events regarding post inflammatory hyper or hypopigmentation that was not noted to be an outlier.

Does cantharidin provide any benefits over other treatments for molluscum contagiosum?

You. There are a variety of recognized therapies for molescom contagiosum other than benign, active nonintervention, in which you do not treat molescom as potential therapies offered typically by primary care physicians. The treatments that we do as dermatologists can either be of physical modality or chemical modality. In the pediatric population, the physical modalities such as cautery, laser, liquid nitrogen, basically scraping and burning, those tend to not be tolerated well in children, and so we often resort to chemical therapies. There have been many studies with other chemicals, such as amiquamod retinoids. Many that come to us have already tried unfruitfully, some over the counter therapies. But of all of them, my favorite go to is contheridin, because in general, that is the therapy that is regarded as painless and well tolerated in the children.

How does the cantharidin applicator work?

You. It's a beautiful device in which you have a very narrow tapered end and so you're provided with a standardized braking tool in which you'd lay it on a flat surface. You would put the device inside and just bring the lever down and it'll snap. There's an ampule inside that will break safely, a glass ampule inside. And then you'll be able to see this purple tinged, it's tinged with gentle violet. So you'll be able to see the actual therapy, a purple tinge liquid that will then with some pressure that you apply which allows you to control, get the medication through a very narrow tapered end which give you precise application. So you have really nice precision on the moluscam lesion you're treating because as we know, molascam lesions can be rather large or small. They vary in size on a given individual oftentimes. And so you really can apply the amount of pressure you need to lightly and gently coat each molluscum lesion.

Can other topical products be used after cantharidin application?

You. We recommend, if possible, to wait a full 24 hours before gently washing with a bland soap and water to remove the medication that was treated, and then following that application. Standard moisturization or petrolatum based products such as vaseline can be applied should any unwanted blistering occur. Otherwise, you can resort back to your gentle skincare and apply moisturizer, sunscreen or anything post 24 hours. Now, if any of the patients do have unwanted adverse events, such as mild blistering in the study, the majority are mild or moderate adverse events. So if there's mild blistering, for example, you're welcome to wash the medication off sooner if need be. But ideally, as done in the study, you would instruct your families to wait a full 24 hours before removing the medication. The.

What is the recommended dosing regimen for cantharidin?

You. Similar to practice a clinical trials mirrored treating at three week intervals. So every three weeks you would continue to treat the existing lesions, any that remain, and new lesions that have emerged while treating, until all lesions have completely resolved. And then usually you have achieved here in that patient and there's no need for continued therapy at that point.

What were the primary endpoints of the CAMP-1 and CAMP-2 trials?

You. While the primary efficacy endpoints in both the camp one and camp two trials, we're actually looking at the percentage of patients that received 100% absolute clearance, which is a pretty steep mark in dermatologic research. Oftentimes we're looking for perhaps 75% improvement or 90%, but not 100% in this trial. What we're looking at is the patients that we followed all the way to day 84 and what percentage of those patients actually cleared 100%. And what we saw in the study is that 50% of those treated with the cantherabin achieved absolute clearance by day 84, compared with only 15.6% of the vehicle treated subjects. The secondary efficacy endpoints that were looked at were really the proportion of subjects that actually cleared all of their treated molascom lesions and these patients were followed at day 21, day 42, and ultimately day 63. In the camp one study, the subjects that were treated actually achieved a significantly greater clearance rate than those that were treated by vehicle. And so statistical significant was achieved at day 42 and also day 63 in the camp one trial. Again, we also saw a significant greater clearance than vehicle for subjects by day 21. This was not seen with the camp two trial. Statistical greater improvement was seen with the treated group versus the vehicle control, but statistical significant was achieved at day 42 and 63, but not at day 21. So what does complete clearance means in both the camp one and camp two trials? Complete clearance means that 100% of all of their treated lesions cleared by the certain time point, and so the subjects were followed out to day 84. So, in an exploratory analysis, what was evaluated was the mean percentage of change from baseline to end of study at day 84. And what we saw were that the contherdin treated subjects achieved a 76% reduction in the treated subjects by the end of study with only 0.3% in the vehicle treated group.

What are some interesting facets of the pathophysiology of molluscum contagiosum?

What I like to explain to my family is that molluscum, the virus, as you know, part of the pox virus family, lives really high on top of the skin. So it has this way of evading the immune system. And so when you apply something like hemtharidin, the mechanism of action is to release the serine protease that then allows the body to recognize and ultimately cause inflammation and attract the necessary chemotactic and cells needed to control and clear the virus. So I think that's pretty unique and special about the moluscum contagiosum virus.

How do you navigate concerns from parents of pediatric patients with molluscum contagiosum?

You oftentimes to navigate that office visit, I first have to see what has occurred up to that point. Oftentimes they were told that no treatment was either available or that no treatment was necessary. And so they're a little disbelief that they were advised not to treat or that nothing was available. And they're surprised to learn when they come to see the specialist and a dermatologist, that we actually have a relatively well tolerated, safe, painless medication for their child. So without shame or blame, oftentimes it's just to educate that in fact, we do have available therapies that are safe and well tolerated in children. And we don't need to go to the physical, destructive modalities that are oftentimes painful and not tolerated in children. And then we kind of reset the playing field, if you will. That's when I usually speak on the medication cantheridin and its utility in the format of treatment for molascom, and then I address the concerns. Oftentimes if they're numerous or too numerous to count lesions, my first treatment in the office may be directed to lesions, and I target to lesions that are concerning to the family. If it's on visible areas such as the face, or unsightly areas such as the groin, I may consider treating those areas that brought them into the office first and then bring them back in three weeks and work on the torso or the limbs, less visible areas that we have a little bit more time in managing other things to navigate. Oftentimes parents don't know to ask or have concerns about. I'll often explore if there's other siblings in the home and if they share baths together. Oftentimes I see that's a mode of transmission in addition to fomites, but how they're spreading it and if they've struggled with one child, I make it very clear that we don't want the same to occur in their other children. And if another child has even one or two moluscum lesions, I will take care of that visit right away, so that again, that child, the second child doesn't auto inoculate. Or again, we get into this pattern of this wait and see, and then they come back when it's absolutely flourished and a bit more challenging to manage.

Which patients are at higher risk of contracting molluscum contagiosum?

You. Definitely the pediatric age group. This is, I would say, primarily a pediatric condition that we're managing. Rarely, you can see molescom develop in adulthood as well. Oftentimes these are adults that are immunocompromised in some fashion. They're immunosuppressed, they have some other genetic predisposition, or they have HIV or some reason why they're susceptible. But outside of that, for the majority, most of all cases that I see occur in the pediatric age group and some into young adolescents. We know it can be transmitted from young adults as a sexually transmitted disease, but in my practice it's primarily for the children.

Any tips on how to reduce the risk of ring warts?

You. The main tip that I use is I use an autoscope connector that goes on the end. I use that, and I actually use the cryo tank. I spray that through there to get it right on the size of the wart. I use different, I have about three different sizes of those in my practice. And so I actually use that and put it on the wart to keep the actual whole, the temperature and the coldness really focused that you don't have this situation which causes a lot of ringwarts where you have a lot of cold density in the center, but externally not as much. And then also, I do a ton of education. Another way that I see that there are a lot of ring warts are that if people don't understand that if there is a blister there, they actually should pop it and unroof it. So I make sure for work care that the instructions are very clear.

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