Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% in the Treatment of Tinea Pedis.
A randomized, double-blind, vehicle-controlled, parallel-design, multiple-site study to evaluate the clinical (therapeutic) effet of a generic Ketoconazole Cream 2% (Douglas Pharmaceuticals America Ltd) compared with the reference standard Ketoconazole Cream 2% (Teva Pharmaceuticals USA Inc) in subjects with a microbiologically-confirmed, clinical diagnosis of tinea pedis. Approximately 675 subjects, male or female, 18 years or older, will be enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
682
Topical treatment for tinea pedis. Subjects will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 +/- 4 days. Each subject is expected to receive 42 +/- 4 doses.
Topical treatment for tinea pedis. Subjects will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 +/- 4 days. Each subject is expected to receive 42 +/- 4 doses.
Moore Clinical Research
Brandon, Florida, United States
Moore Clinical Reseach
Tampa, Florida, United States
FXM Research International
Belize City, Belize
Therapeutic cure of tinea pedis
The proportion of subjects in each treatment group with a Therapeutic Cure of tinea pedis at the test-of-cure visit conducted 2 weeks after the end of treatment (Day 56 +/- 4). Therapeutic cure is defined as having both a clinical and mycological cure of tinea pedis.
Time frame: 2 weeks post-treatment (Day 56)
Clinical cure of tinea pedis
The proportion of subjects in each treatment group with a Clinical Cure at Day 56 +/- 4. Clinical Cure is defined as a total severity score of \</= 2, with no individual severity score of \>1. This is calculated using The Clinical Signs and Symptoms of Tinea Pedis rated by the Investigator using a standardized rating scale as follows: 0=none (complete absence of any sign or symptom) 1. Mild (slight) 2. moderate (definitely present) 3. Severe (Marked, intense). The following signs and symptoms will be rated: Signs = fissuring/cracking, erythema, maceration, and scaling Symptoms = pruritis and burning/stinging
Time frame: 2 weeks post-treatment (Day 56)
Mycological cure of tinea pedis
The proportion of subjects in each treatment group with a Mycological Cure of tinea pedis at Day 56 +/- 4. Mycological Cure is defined as having a negative KOH test AND a negative fungal culture.
Time frame: 2 weeks post-treatment (Day 56)
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Topical placebo to treatment for tinea pedis. Subjects will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 +/- 4 days. Each subject is expected to receive 42 +/- 4 doses.