SB208, a stable, silicone-based hydrogel formulation of berdazimer sodium that stores nitric oxide until it can be released at the application site, was shown to be well-tolerated and effective for the treatment of interdigital tinea pedis, according to a study published in the Journal of Drugs in Dermatology.
With this double-blind, phase 2, randomized clinical trial, researchers assessed the safety and efficacy of SB208 hydrogel vs a matching vehicle. Three different doses of SB208 were administered once a day for 14 days (2%, 4%, and 16%) to study participants with culture-confirmed tinea pedis. The same procedure was followed for a matching vehicle group. The primary efficacy outcome was the percentage of participants with negative fungal cultures at day 14, with secondary outcomes on days 14 and 42 being negative potassium hydroxide wet mount test and culture to measure mycological cure, and reduced signs and symptoms on a 4-point scale to measure clinical cure. Safety and tolerability were monitored through hemoglobin and methemoglobin levels, adverse events, and physical examinations.
Of the 222 participants, 54 discontinued treatment and 168 completed the study. Of those who discontinued, 52 did so due to a negative fungal culture at baseline. By day 14, 62% of patients in the SB208 treatment groups had negative fungal cultures (P=.04) compared with 43% in the matching vehicle-treated group. The 4% SB208 group had the highest rate of negative cultures compared with the vehicle group (67.6% vs 42.9%; P =.03). By day 42, the SB208 treatment groups had 47% mycological cure vs 31% in the vehicle group (P =.08), and 23% of SB208 treatment groups maintained clinical cure compared with 14% of the vehicle group. Adverse events were mild and unrelated to study medications and there were no reported safety concerns. No one discontinued the study due to adverse events.
Study investigators concluded, “[t]ogether, the positive efficacy data and favorable safety profile from this clinical trial, suggest that additional studies of SB208 in the treatment of tinea pedis and other mycologic diseases are warranted.”
Disclosure: This clinical trial was funded by Novan, Inc. Please refer to reference for a complete list of authors’ disclosures.
Elewski BE, Kircik LH, Stasko N, et al. A phase 2, controlled, dose-ranging study of SB208, an investigational topical nitric oxide-releasing drug, for the treatment of tinea pedis. J Drugs Dermatol. 2018;17(8):888-893.