Once a Day Topical Treatment for Athlete's Foot Fungus Inbetween the Toes in Males and Females (NCT00856596) | Clinical Trial Compass
UnknownPhase 3
Once a Day Topical Treatment for Athlete's Foot Fungus Inbetween the Toes in Males and Females
United States30 participantsStarted 2009-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Males and females 18 years of age and over.
✓. Women of child bearing age must have a negative urine pregnancy test at Day 0 (baseline) and Day 42 (visit 6) or at the discontinuation visit and must agree to use an acceptable method of contraception during the study.
✓. Subjects must have clinical evidence of interdigital tinea pedis of one or both feet characterized by: moderate erythema and scaling and mild pruritis.
✓. The clinical diagnosis must be confirmed by a positive KOH preparation, where fungal elements are visible from a skin scraping of the interdigital area of the feet.
✓. Fungal cultures obtained at the baseline visit must be positive by day 14 for the subject to remain in the study.
✓. All non-study medications not specifically excluded by this protocol may be continued.
✓. All chronic diseases must be stable for at least one month.
✓. Acute illnesses must be stabilized before enrollment.
Exclusion criteria
✕. Under 18 years of age.
✕. Pregnant or lactating females.
✕. Treatment of sertaconazole or an investigational drug within the last 30 days prior to study enrollment.
✕. No medications or emollients or foot powders or treatments other than those used in the study are to be applied to the treatment areas.
What they're measuring
1
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).