Once a Day Topical Treatment for Athlete's Foot Fungus Inbetween the Toes in Males and Females
Recruitment status was: Recruiting
Drug: Sertaconazole nitrate cream 2%
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efficacy Of Sertaconazole 2% (ERTACZO) in the Treatment of Interdigital Tinea Pedis With Once a Day Treatment for 4 Weeks|
- To compare the efficacy and safety of sertaconazole 2% cream applied once a day for four weeks in the treatment of patients with KOH positive and culture positive symptomatic interdigital tinea pedis (athlete's foot). [ Time Frame: Baseline visit, 1 week, 2 weeks, 4 weeks, 6 weeks ] [ Designated as safety issue: No ]
- To compare the time to successful clinical and mycological treatment outcomes for sertaconazole 2% cream applied once a day for four weeks in the treatment of patients with KOH positive and culture positive symptomatic interdigital tinea pedis. [ Time Frame: Baseline visit, 1 week, 2 weeks, 4 weeks, 6 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||September 2009|
|Estimated Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Males and females with athlete's foot
Male and female subjects with athlete's foot inbetween their toes without nail involvement
Drug: Sertaconazole nitrate cream 2%
Once a day topical cream
Other Name: Ertaczo cream 2%
The dermatophytes are a group of pathogenic fungi that inhabit and invade keratinized tissue including hair, skin and nails in humans. Infections caused by the three genera of organisms making up the dermatophytes include: Trichophyton, Microsporum and Epidermophyton. Infections due to the dermatophytes are termed dermatophytosis or tinea.
Tinea pedis (athlete's foot) is most commonly caused by Trichophyton rubrum, and less commonly by Trichophyton mentagrophytes and Epidermophyton floccosum.
Tinea infections have been on the rise for variety of reasons including: an aging population, an increase in immunocompromised individuals, increase use of gyms, swimming pools, sports activities, wearing of occlusive footwear, and the organisms themselves becoming more resistant to therapy.
Treatment for tinea pedis usually involves the use of topical therapy with azoles or similar antifungal agents. The efficacy of the topical agent depends on the duration of therapy, type of lesion, the mechanism of action of the drug, and the viscosity, hydrophobicity and acidity of the formulation.
Sertaconazole is a broad spectrum, antifungal agent effective against Candida and dermatophytes. It has also shown antibacterial and anti-inflammatory activity. Skin absorption studies have revealed acceptable therapeutic levels of sertaconazole remained in the skin until 48 hours after application. Half life for drug clearance from the skin is 60 hours. Skin tolerability and phototoxicity studies have revealed sertaconazole to be effective and safe when compared to other topical antifungal agents.
In 2004 sertaconazole nitrate 2% cream, was FDA approved for the topical treatment of interdigital tinea pedis in immunocompetent patients 12 years of age and older, caused by Trichophyton rubrum. Trichophyton mentagrophytes and Epidermophyton floccosum. The approved dosage is twice a day for a total of four weeks to the affected area. This treatment regimen may prove to be difficult for many patients to follow and cause a lower cure rate than would be expected.
It would seem reasonable to postulate that a once a day application would provide adequate therapeutic levels for interdigital tinea pedis based on several previous findings. Acceptable therapeutic levels of drug were maintained in the skin after 48 hours of application and the half-life of the drug is 60 hours. Patient compliance and therefore a higher mycological cure rate and better clinical outcome should theoretically occur with once a day dosing of sertaconazole 2%. Once a day dosing should prevent early discontinuation and better compliance for patients with tinea pedis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00856596
|United States, New York|
|Jamaica Hospital Medical Center|
|Jamaica, New York, United States, 11418|
|Principal Investigator:||Jeffrey Weinberg, MD||Jamaica Hospital Medical Center|