SB204 gel safe, effective treatment for acne

The topical nitric oxide-releasing gel, SB204, is safe and effective, and further research on the novel treatment for acne vulgaris is warranted, according to research presented at the American Academy of Dermatology Annual Meeting.

“This study is exciting in that a new, novel nitric oxide releasing gel showed efficacy in standard study parameters in patients with moderate-to-severe acne,” Lawrence Eichenfield, MD, of the University of California, San Diego, told Healio Family Medicine. “Both inflammatory and noninflammatory lesion counts, and the percentage of patients who made the 'clear’ or ‘almost clear’ and at least two grades improvement in severity scoring, were statistically better than vehicle with a 4% gel formulation used once a day over 12 weeks. The gel formulations showed good tolerability data as well.”

Lawrence Eichenfield, MD

Eichenfield and colleagues conducted a phase 2, multicenter, randomized, double-blind study to determine the safety and efficacy of two doses of SB204 and vehicle in patients with moderate-to-severe acne. They also evaluated once-daily vs. twice-daily doses. The study included 213 participants assigned to receive treatments of either SB204 2% twice daily, SB204 4% once daily or twice daily, or vehicle once or twice daily for 12 weeks. Of the 213 participants, 191 completed the study.

According to the researchers, there was a statistically significant difference in the mean absolute change from baseline in the number of both noninflammatory and inflammatory lesions among patients treated with SB204 4% at week 12. In addition, in a time-to-event analysis, the median inflammatory lesion counts differed between patients treated with BS240 4% and those who received the vehicle within 4 weeks. Once-daily SB204 4% treatment was as effective as twice-daily dosing. The researchers also reported a 6% difference in IGA success in favor of the various SB204 treatments, compared with the vehicle-treated participants. In addition, the gel was found to be tolerable in more than 95% of participants.

“As someone who treats acne patients every day, it is exciting news that this novel medication may move forward into phase 3 studies and may be something to have in our armametarium for our patients the future,” Eichenfield said. – by Jason Laday

Disclosure: Eichenfield reported no relevant financial disclosures.

Reference:

Eichenfield L, et al. F053. Late-Breaking Research: Clinical Trials. Presented at: American Academy of Dermatology 74th Annual Meeting; March 4-8, 2016; Washington, D.C.