FDA Discourages Self-Diagnosing, Treating Molluscum as Drug Decision Dates Approach

A new consumer update from the US Food and Drug Administration (FDA) this month stressed the potential harm of self-diagnosing and treating molluscum contagiosum without guidance from health care professionals.¹

A common skin infection—particularly in children—molluscum is a viral infection presenting as warts on nearly any region of the body. Outbreaks are susceptible among improperly treated or untreated patients— especially those not practicing adequate hygiene—and therefore patients should be operating with an official diagnosis before making any other action, the FDA noted.

“Molluscum eventually goes away on its own without treatment, usually in six to 12 months. Although in some people it can take up to five years,” the FDA wrote. “If you have molluscum, a skin doctor (dermatologist) or other health care professional can evaluate your symptoms and recommend ways to manage your condition.”

A major component in the matter of the FDA needing to address the issue of self-treatment for possible molluscum is the fact that no drug is currently marketed by the agency to treat the infectious skin disease.

“It’s likely that unapproved products marketed to treat molluscum do not do what they claim, and the ingredients in them could cause adverse effects,” the FDA update read. “The FDA has received reports of side effects in children and adults associated with some of these products, including skin reddening, abrasion from skin scratching, and permanent scarring.”

Particularly, essential oil-based products have been falsely described or marketed as molluscum treatments; even these run a risk of causing allergic reactions without actual resolution of the skin infection, the FDA noted.

At the time of the update, a pair of drug candidate applications have been accepted by the FDA for the potential treatment of molluscum.

VP-102, from Verrica Pharmaceuticals, is a drug-device combination product featuring a controlled formulation of cantharidin (0.7% w/v) delivered via single-use applicator for topical dosing and targeted administration in patients. The FDA will decide on the company’s most recently accepted New Drug Application (NDA) by July 23 this year.²

Another potential agent, Novan’s bedazimer gel 10.3%, is a self-applied topical therapy with an FDA decision date in early January 2024.³

The timing of the FDA’s consumer update relative to the NDA application decision dates for a pair of promising topical drugs for molluscum may not be coincidental. Indeed, in a high rate of patient cases since the infectious disease was first described in 1817, clinicians have counseled children and their parents to “wait (the infection) out,” wrote Vikash S. Oza, MD, in a JAMA Dermatology editorial last July.⁴

“Although molluscum in an otherwise healthy child is self-resolving, the average case lasts 13.5 months, and 13% of cases are not resolved within 2 years,” Oza, a professor in the Ronald O. Perelman Department of Dermatology at NYU Grossman School of Medicine, wrote. “Understandably, many families look to fast-forward their child’s experience with the infection.”

Many clinicians presently use in-office practices including cryotherapy, curettage, and cantharidin treatment to help manage molluscum severity. “For many pediatric dermatologists, myself included, cantharidin is the go-to for in-office treatment, given that the procedure itself is painless and the next-day blistering and inflammation are often tolerable when an experienced clinician has applied it,” Oza wrote.

Many of his peers may find it difficult to move on from compounded cantharidin 0.7%, Oza wrote, but he believes VP-102 may have the potential to “increase the accessibility” of cantharidin to not only dermatologists, but other prescribing health care professionals encountering the highly prevalent molluscum.

Advancing treatment options to include not only those with the option to be administered at home, but those with clinicial benefit in reduced molluscum spread would be a notable improvement, he explained.

“Families often seek treatment to control the further spread in their child or among their family and to reduce the amount of MC in visible areas, given the stigma of having a contagious infection,” Oza wrote. “Therefore, treatments, such as VP-102 and berdazimer gel, which are tolerated and have been shown to reduce lesion counts, even without rapid or complete resolution, will likely be welcomed.”

In only a few weeks, the FDA may need to again update its consumer recommendations on managing molluscum.

References

1. ^{Don’t Use Products Marketed to Treat Molluscum, a Common Skin Condition. Consumer Updates. FDA. Updated June 1, 2023. https://www.fda.gov/consumers/consumer-updates/dont-use-products-marketed-treat-molluscum-common-skin-condition?utm_medium=email&utm_source=govdelivery}
2. ^{Kunzmann K. FDA Accepts New VP-102 Application for Molluscum Contagiosum. HCPLive. Published February 28, 2023. https://www.hcplive.com/view/fda-accepts-new-vp-102-application-molluscum-contagiosum}
3. ^{Smith T. FDA Accepts Drug Application of Topical Antiviral Gel for Molluscum Contagiosum. HCPLive. Published March 7, 2023. https://www.hcplive.com/view/fda-accepts-drug-application-topical-antiviral-gel-molluscum-contagiosum}
4. ^{Oza VS. Molluscum Contagiosum Therapeutics—New Options May Be Around the Corner. JAMA Dermatol. 2022;158(8):863–864. doi:10.1001/jamadermatol.2022.2719}