Study: Econazole Nitrate Foam Improves Symptoms of Tinea Pedis
Tinea pedis is the most common form of dermatophytosis and the related itching frequently affects quality of life. Two phase 3 clinical studies have shown that a topical foam formulation of econazole nitrate 1% safely and effectively can be used to treat tinea pedis. Econazole nitrate is a broad-spectrum topical antifungal agent with known clinical or in vitro activity against numerous dermatophytes, including Epidermophyton floccosum, Trichophyton rubrum, and T mentagrophytes, the etiologic agents in tinea pedis.
A study by Fleischer and colleagues, which recently was presented at the 2016 Fall Clinical Dermatology Conference, in Las Vegas, used data from the phase 3 clinical studies to evaluate whether econazole nitrate topical foam 1% also improved symptoms of itch in participants with interdigital tinea pedis.
Econazole nitrate foam 1% was compared with foam vehicle, in the randomized, doubleblind, vehicle-controlled, multicenter, phase 3 studies in participants with interdigital tinea pedis. Participants applied a thin, uniform layer of study treatment, once daily for 4 weeks, to all affected regions of both feet. Evaluation was performed at day 8, day 15, day 29, and day 43. The study observed the improvement of itch during the course of treatment. Itch was rated at each visit as absent (0), mild (1), moderate (2), or severe (3). In the 2 phase 3 clinical trials, 505 participants were enrolled in the original studies; 495 were dispensed study medication.
The current analysis conducted by Fleischer et al included 173 participants in the econazole nitrate topical foam group, and 166 participants in the foam vehicle group, from among the original participants in the 2 phase 3 clinical studies. Baseline itch severity (each treatment group) showed that >90% of participants had mild or greater itch and >69% of participants had moderate to severe itch.
The assessment of itch during treatment in study 1 demonstrated that econazole foam 1% was numerically superior to vehicle in achieving absence of itch. Complete resolution of itch began as early as day 8 and improvement continued for 2 weeks after treatment cessation. With foam vehicle, no evidence of continued improvement after treatment cessation was noted. The assessment of itch during treatment in study 2 showed that econazole foam 1% was numerically superior to vehicle in achieving absence of itch. Complete resolution of itch began as early as day 8 and improvement continued for 2 weeks after treatment cessation. With foam vehicle, there was no evidence of continued improvement after treatment cessation.
Econazole nitrate foam 1% was well tolerated, with a similar safety profile to that of foam vehicle. No serious AEs and no treatment-related AEs were reported for the econazole nitrate foam 1% group. (In the foam vehicle group, 2 treatment-related AEs were reported: moderate application-site dermatitis and mild application-site pain.)
“The present analysis showed that most participants also achieved complete resolution of itch during 4 weeks of treatment with econazole nitrate topical foam 1%, and that itch continued to improve in the 2 weeks after treatment cessation,” the researchers concluded. “Itch can be a bothersome symptom of tinea pedis. The results of this study showed that econazole nitrate topical foam 1%, an effective and safe treatment option for interdigital tinea pedis, may also improve patients’ quality of life.”
Fleischer AB, Raymond I. Improvement of Tinea Pedis Itch: Once-Daily Treatment With Econazole Nitrate Foam 1%. Poster presented at The 2016 35th Anniversary Fall Clinical Dermatology Conference, Las Vegas, Nevada. October 20-23, 2016.