Clinical Trials Resource Center

Athlete's Foot (Tinea Pedis)

April 17, 2017

Novan released positive results from a phase II trial of SB208 for the treatment of infections caused by dermatophytes such as Trichophyton rubrum (T. rubrum) for tinea pedis, or athlete’s foot. Clinical activity against dermatophytes was measured by incidence of a negative fungal culture after two weeks of treatment. In the double-blind, randomized, vehicle-controlled, dose-ranging clinical trial, the tolerability, safety and antifungal activity of SB208 was evaluated in 222 patients with clinical signs and symptoms of tinea pedis. Patients were randomized evenly to one of three active or vehicle treatment arms, applying either SB208 Gel (2%, 4% or 16%) or vehicle once-daily for two weeks, followed by a four-week post-treatment observation period. Efficacy assessments were made on a modified intent-to-treat population (mITT) comprised of patients who had a positive baseline culture for dermatophytes such as T. rubrum. The primary endpoint in this study was the proportion of patients in each treatment group achieving negative fungal culture at day 14. In the primary efficacy analysis of patients with evaluable culture results, 80.6% (p=0.002) of patients treated with SB208 4% and 74.2% (p=0.016) of patients treated with SB208 16% achieved negative fungal culture at day 14 versus 45.5% of patients treated with vehicle. Similar results were observed in the per-protocol analysis, with both SB208 4% and 16% demonstrating statistical superiority to vehicle treated subjects (p<0.05). Based on the data generated in this SB208 phase II dose-ranging trial, Novan will evaluate late-stage development opportunities in superficial cutaneous fungal infections, such as a phase II trial in patients with onychomycosis, to be initiated as early as the second half of 2017.

October 12, 2009

Topica Pharmaceuticals issued positive results from a phase II trial of luliconazole for the treatment of tinea pedis (athlete's foot). This multi-center, randomized, double blind, trial evaluated the safety and efficacy of 1% luliconazole cream administered once daily for 14 or 28 days in patients with moderate to severe tinea pedis. The primary endpoint was the proportion of subjects who achieved complete clearance at 2 weeks post-treatment. At day 42, the 14-day dose resulted in a 53.7% complete clearance rate compared with a placebo rate of 4.5% (p≡0.0001) and the 28-day dose resulted in a 45.7% complete clearance rate compared with a placebo rate of 10% (p≡0.0071). There was no statistical difference in complete clearance between the 14 or 28 day once daily dosing regimen (p≡0.4928). The mycologic results also improved over time post treatment. The 14-day dose resulted in a 78% mycologic cure at day 28 and 82.9% at day 42. No serious or drug-related adverse events were reported.