
- May/June 2026
- Volume 42
- Issue 02
Recent advances in the treatment of molluscum contagiosum
New FDA-approved options for molluscum contagiosum—in-office cantharidin and at-home berdazimer gel—reduce stigma and avoid painful removal.
Molluscum contagiosum (MC) is a common, benign, viral skin infection caused by the MC virus (MCV), a member of the Poxviridae family.1 It manifests as small, raised, dome-shaped papules with central umbilication. MC affects approximately 6 million individuals in the US annually, with the highest incidence among those younger than 14 years.2 Transmission primarily occurs through direct contact with infected individuals or through sharing infected materials, including clothing, towels, toys, and pool equipment.3
Natural course and transmission prevention
Health care providers often take a noninterventional approach known as “benign neglect,” allowing the infection to resolve on its own.4 A retrospective study found that MC persists on average approximately 9.9 months in untreated individuals without immunodeficiencies, with about 77% of participants reporting no sequelae.5 Although MC can be left untreated, it can cause psychosocial distress due to skin irritation, visibility of lesions, and fear of infecting others. In fact, MC is transmitted to other children in the household in approximately 40% of cases.6 Infection may be prevented by covering lesions with clothing or a bandage, washing hands thoroughly after touching bumps, and avoiding sharing contaminated items.
Traditional treatment approaches
Treatment of MC previously focused on mechanical removal in the form of curettage, cautery, laser therapy, or cryotherapy, which can cause pain, bleeding, and scarring.7 Other categories of treatment include chemical, immunomodulatory, and
antiviral methods.
Recent FDA-approved treatments
There has been a recent shift toward FDA-approved therapies for MC. Cantharidin topical solution, 0.7% (Ycanth; Verrica Pharmaceuticals Inc) was approved in July 2023 and must be administered in-office by a clinician. And in January 2024, berdazimer topical gel, 10.3% (Zelsuvmi; LNHC, Inc) became the first FDA-approved at-home treatment for MC.
Cantharidin
Mechanism of action and background
Cantharidin is a vesicant and keratolytic agent that activates neutral serine/threonine proteases to cause intraepidermal blistering and acantholysis.8 Cantharidin is produced by beetles of the Coleoptera order and Meloidae family, commonly known as blister beetles or Spanish fly. It is a long-standing remedy in traditional Chinese medicine and in folk medicine from Europe, Africa, and other parts of Asia used to treat a variety of ailments, from ulcers and furuncles to rabies, cancer, and
abdominal masses.9
Regulatory history
Dermatologists have treated MC and warts with cantharidin since the 1950s. However, the FDA removed cantharidin from the market in 1962 when no efficacy data were submitted in compliance with the Drug Efficacy Study Implementation program under the Food, Drug, and Cosmetic Act. It was then added to the FDA’s bulk substances list in 1998, which permitted pharmacy compounding of cantharidin and topical application by a physician or pharmacist.8
Clinical trial evidence
The approval of cantharidin 0.7% was based on findings from 2 identical phase 3 randomized, vehicle-controlled, double-blind clinical trials, CAMP-1 (NCT03377790) and CAMP-2 (NCT03377803), conducted in
2018 with a total of 528 participants. VP-102, the drug-device combination containing cantharidin, 0.7% (weight/volume), was administered every 21 days for a maximum of four treatments. This resulted in complete lesion clearance rates of 46.3% and 54.0% vs 18% and 13% with the vehicle in CAMP-1 and CAMP-2, respectively. Mild to moderate adverse effects (AEs) were reported by the majority of participants in the treatment groups, including application-site vesicles, pain, pruritus, erythema, and scabs.10
Berdazimer
Mechanism of action and background
Berdazimer is a topical nitric oxide (NO)–releasing agent, a class of drugs studied in dermatology for its immunomodulatory and antimicrobial properties. At high concentrations, NO is oxidized and inhibits molecular pathways involved in MC viral replication.11 This was first investigated in 1999 in a clinical trial, which reported a 75% cure rate for MC in the group treated with topical acidified nitrite vs 21% in the control treatment group.12 Several AEs were noted, including skin discoloration and irritation, but this did not prevent
successful treatment.12
Clinical trial evidence
Berdazimer gel 10.3% is the first novel drug for the treatment of MC and the only topical prescription medication for MC approved for application outside a medical office, offering a convenient option for families to treat MC safely at home. It was approved after the phase 3 multicenter, vehicle-controlled, double-blind, randomized B-SIMPLE4 clinical trial (NCT04535531) conducted between 2020 and 2021 with 891 participants. Berdazimer gel 10.3% or the vehicle gel was applied as a thin layer to all lesions once daily for 12 weeks. At week 12, 32.4% in the berdazimer group achieved complete clearance of MC lesions vs 19.7% in the vehicle group. AE rates were low, with the most common being application-site pain and mild to moderate erythema.2
Emerging therapies: Immunotherapy
Additionally, recent studies have investigated the effectiveness of intralesional injections of various antigens to combat cutaneous viruses through stimulating cell-mediated immunity.13 One study compared intralesional injections of the measles-mumps-rubella (MMR) vaccine with tuberculin purified protein derivative (PPD) antigens for MC in 30 participants. A statistically significant clearance of MC in the MMR- and PPD-treated groups was found vs those given saline, although there was no significant difference between the MMR- and PPD-treated groups themselves.14 Similar results were reported when comparing intralesional
Candida antigen vs varicella-zoster vaccine in a group of 48 patients.15 These interventions are promising options for clearing resistant MC with
minimal AEs.14,15
Conclusion
Significant advancements have been made in the development of noninvasive treatments for MC, particularly with the FDA approval of cantharidin and berdazimer, offering alternatives to mechanical removal and benign neglect (Table16,17). Emerging immunotherapies further expand the therapeutic landscape, especially for patients with refractory MC. Continued research is essential to improve patients outcomes, particularly children who may experience discomfort and social stigma associated with the
skin disease.





