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.
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.
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