Clinical Trial: Once a Day Topical Treatment for Athlete's Foot Fungus Inbetween the Toes in Males and Females
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Efficacy Of Sertaconazole 2% (ERTACZO) in the Treatment of Interdigital Tinea Pedis With Once a Day Treatment for 4 Weeks
Brief Summary: The topical cream, Sertaconazole (Ertaczo), has been FDA approved for the treatment of athlete's foot using twice a day dosing for 4 weeks. This study wants to see if sertaconazole will work equally as well with once a day dosing for 4 weeks for athlete's foot.
Detailed Summary:
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 ped
Sponsor: Jamaica Hospital Medical Center
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: 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 ]
Original Secondary Outcome: Same as current
Information By: Jamaica Hospital Medical Center
Dates:
Date Received: March 5, 2009
Date Started: March 2009
Date Completion: September 2009
Last Updated: August 3, 2009
Last Verified: August 2009
