Berdazimer Sodium Plus Hydrogel Provides Rapid Lesion Clearance in Molluscum Contagiosum

Molluscum contagiosum occurs in approximately 5% to 18% of HIV-infected people, but is becoming rare in areas of the world with good access to highly effective antiretroviral therapies (HAART).16 It is caused by an infection of the epidermal keratinocytes by the molluscum contagiosum virus, a double-stranded DNA virus belonging to the Poxviridae family.16,17 Patients present with small (≤5 mm in diameter), raised lesions that are usually white, pink, or flesh colored with a dimple or pit in the center.17 The lesions are typically smooth, firm, and pearly appearing, and can affect any area of the body, although they are rarely found on the palms or soles. They may occur as solitary lesions or in groups and typically resolve within 6 to 12 months without any scarring.17 Genital lesions may take longer to resolve, and healing times up to 4 years have been reported.16,17 Photo Credit: Medical Images RM/AL LAMME.

Molluscum contagiosum occurs in approximately 5% to 18% of HIV-infected people, but is becoming rare in areas of the world with good access to highly effective antiretroviral therapies (HAART).16 It is caused by an infection of the epidermal keratinocytes by the molluscum contagiosum virus, a double-stranded DNA virus belonging to the Poxviridae family.16,17

Patients present with small (≤5 mm in diameter), raised lesions that are usually white, pink, or flesh colored with a dimple or pit in the center.17 The lesions are typically smooth, firm, and pearly appearing, and can affect any area of the body, although they are rarely found on the palms or soles. They may occur as solitary lesions or in groups and typically resolve within 6 to 12 months without any scarring.17 Genital lesions may take longer to resolve, and healing times up to 4 years have been reported.16,17

Photo Credit: Medical Images RM/AL LAMME.

SB206 12% represents a well-tolerated topical treatment for molluscum contagiosum that can be applied at home by patients or caregivers, solving an unmet medical need.

Once-daily topical SB206 at concentration of 12% is associated with a relatively balanced benefit-to-risk profile in patients with molluscum contagiosum, providing lesion clearance with a favorable tolerability profile. This is according to study results in the Journal of the American Academy of Dermatology.

The investigational SB206 product consists of a gel containing berdazimer sodium plus a hydrogel. The addition of a hydrogel facilitates the release of nitric oxide at the time of topical application. This phase 2 study randomly assigned patients aged ≥2 years with molluscum contagiosum to either topical SB206 (n=190) or a vehicle control (n=66) for a 12-week treatment period. Topical SB206 was administered twice a day at concentrations of 4%, 8%, 12%, or once a day at 12%.

At 12 weeks, the proportion of patients with molluscum contagiosum who experienced complete clearance of lesions was 13.2%, 41.0%, and 35.1% with twice-daily SB206 of 4%, 8%, or 12%, respectively, compared with 20.0% of patients who were treated with vehicle control. In addition, 41.9% of patients who were treated with once-daily SB206 12% experienced complete lesion clearance at 12 weeks.

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Approximately 10.6% of patients who applied the SB206 gel reported application-site erythema. Treatment discontinuation was most often associated with application-site reactions. A total of 2 patients in each of the twice-daily SB206 groups discontinued therapy because of adverse events.

Limitations of the study included the short follow-up period, the lack of assessment for other disease-related outcomes of interest, as well as the small sample size.

“A rapid reduction in molluscum contagiosum lesion count from baseline may be particularly important from both a patient/caregiver and clinician perspective when administering a topical treatment,” the researchers wrote, “particularly for patients with a greater lesion count at baseline.”

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.

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Reference

Hebert AA, Siegfried EC, Durham T, et al. Efficacy and tolerability of an investigational nitric oxide-releasing topical gel in patients with molluscum contagiosum: a randomized clinical trial [published online October 3, 2019]. J Am Acad Dermatol. doi:10.1016/j.jaad.2019.09.064