Study Design and Efficacy Results for Tinea Pedis Clinical Trials. Kathleen Fritsch, Ph.D. Division of Biometrics III, FDA. Part I: Clinical Trial Design for Tinea Pedis Trials. Trial Characteristics. Trial Design Randomized, double-blind, vehicle controlled, multicenter Indications
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Kathleen Fritsch, Ph.D.
Division of Biometrics III, FDA
(cultures take up to 4 weeks—treatment may be completed before baseline culture results are known)
Signs and symptoms: at a minimum--erythema, pruritus, scaling (may include others)
Primary timepoint for efficacy evaluation at least 2 weeks after completing treatment
→May be significant time lag (weeks or months) between end of treatment and assessment of cure
Efficacy results from selected clinical trials
Criteria for dataset selection:
The 9 products/formulations/regimens identified represent:
*Data from 2 studies
which can vary substantially from trial to trial
Complete cure: 20%
Effective Treatment: 50%
Negative Mycology: 70%