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Two promising topical treatments for molluscum contagiosum

This common skin condition has been historically difficult to treat, but new therapies could be first U.S. FDA-approved options.
1/22/2023

A recent study in Dermatology and Therapy reviews the problem of molluscum contagiosum (MC), a common skin condition, and outlines two new topical treatments that may be the first approved by the U.S. Food and Drug Administration.

The authors of the study1 point out this condition mainly affects children, sexually active adults and immunocompromised patients.2 Caused by a DNA poxvirus, molluscum contagiosum is one of the five most common skin diseases worldwide, and the third most common viral skin infection in children with a reported prevalence3,4 of 5.1%-to-11.5%. Prevalence varies by geographic area, with greater frequency in regions with hot climates.4

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A difficult disease to treat

MC is characterized by single or multiple, small (2-5 mm), pink or skin-coloured papules, with a typical central umbilication.5

They usually appear on the face, trunk and extremities in children, on the genitals in young adults, and may be associated with itching, eczema and secondary bacterial infections.

It's a self-limited condition that usually resolves within six-to-nine months in immunocompetent individuals. For this reason, the decision to treat or not is made on a case-by-case basis.

A wide variety of treatments are available, but none are FDA-approved and there is no consensus on the optimal approach, mainly due to a lack of evidence.

Physical modalities are widely used, but require repeated outpatient visits for administration, are painful and difficult to perform in children, and are associated with the possibility of residual scarring and post hypo- or hyperpigmentation.

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Two experimental topical drugs, VP-102 and SB206 are designed to overcome the limitations of current treatments.

VP-102

The drug is a new standardized preparation of cantharidin, a natural terpenoid compound derived from the digestive tract of beetles, which has long been used for MC.6 However, the safety and efficacy of doses, regimens and methods of application have not been evaluated in large-scale controlled trials.

Recently, two phase III trials (CAMP-1 and CAMP-2) of identical design, randomized, double-blind and controlled by a control device identical in all respects to VP-102 (except the active ingredient, cantharidin), were conducted on a total of 528 individuals with MC aged two years and older at 31 centers across the U.S.7 At the end of the study, VP-102 was statistically superior to the control in completely clearing MC lesions in both trials.

SB206

This drug is a new topical nitric oxide (NO)-releasing drug composed of two components: a gel containing sodium berdazimer (a macromolecule), co-administered with a carboxymethylcellulose hydrogel. The combination promotes the release of NO from the macromolecule at the time and site of application, thereby minimizing systemic exposure.

NO provides localized immunity against foreign organisms, acting both as a short-lived immune modulator and as a direct broad-spectrum antimicrobial agent against bacteria, yeasts, fungi and viruses, including MC.

A phase III, multicenter, randomized, double-blind, controlled study was conducted in 891 patients aged six months or older with MC lesions, at 31 centers across the U.S.8 At the end of the study, 32.4% of patients in the SB206 group achieved complete clearance compared to 19.7% in the control group (p < 0.0001).

In conclusion, the good safety and efficacy results obtained by VP-102 and SB206 in large cohorts of patients suggest that they have the potential to become the first U.S. FDA-approved therapies for MC.

References

1. Lacarruba, F. et al. (2022). New Developing Treatments for Molluscum Contagiosum. Dermatol Ther 12, 2669-2678.

2. Chen, X., Anstey, A.V. and Bugert J.J. (2013). Molluscum contagiosum virus infection. Lancet Infect Dis 13(10), 877–888.

3. Eichenfield, L. et al. (2021). Therapeutic approaches and special considerations for treating molluscum contagiosum. J Drugs Dermatol 20(11), 1185–1190.

4. Olsen, J.R. et al. (2014). Epidemiology of molluscum contagiosum in children: a systematic review. Fam Pract 31(2), 130–136.

5. Leung, A.K.C., Barankin, B., and Hon, K.L.E. (2017). Molluscum contagiosum: an update. Recent Pat Inflamm Allergy Drug Discov 11(1), 22–31.

6. Del Rosso, J.Q. and Kircik, L. (2019). Topical cantharidin in the management of molluscum contagiosum: preliminary assessment of an ether-free, pharmaceutical-grade formulation. J Clin Aesthet Dermatol 12(2), 27–30.

7. Eichenfield, L.F. et al. (2020). Safety and efficacy of VP-102, a proprietary, drug-device combination product containing cantharidin, 0.7% (w/v), in children and adults with molluscum contagiosum: two phase 3 randomized clinical trials. JAMA Dermatol 156(12), 1315–1323.

8. Browning, J.C. et al. (2022). Efficacy and safety of topical nitric oxide-releasing berdazimer gel in patients with molluscum contagiosum: a phase 3 randomized clinical trial. JAMA Dermatol 158(8), 871-878.

This article has been translated from its original French and originally appeared on our sister site Profession Santé.

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