The current study was randomized, double blind, placebo-controlled, prospective, multicenter, comparative therapeutic equivalence study. The study duration for each patient was 6 weeks: Following were the visit details. V1-Baseline and Randomization Visit (Day 1). V2- End of therapy visit (at the end of week 2 + 2 days). V3- Follow up visit (at the end of week 4 + 2 days). V4 - Test of cure visit ( at the end of week 6 + 4 days).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
693
Topical application for two weeks
Topical application for two weeks
Topical application for two weeks
Moore Clinical Research Inc
Brandon, Florida, United States
Savin Medical Group Research
Miami, Florida, United States
International Dermatology Research, Inc,
Miami, Florida, United States
Mycological cure and clinical cure for a single target lesion for Trichyphyton rubrum
After 6 weeks the skin scrapping will be collected for culture to find out the growth of T rubrum. Absence of growth suggests complete cure.
Time frame: week 6 + 4 days
Mycological cure and clinical cure for Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum
After 6 weeks the skin scrapping will be collected for culture to find out the growth of T rubrum, T Mentagrophytes or E floccosum. Absence of growth suggests complete cure.
Time frame: week 6 + 4 days
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FXM Research Corp
Miami, Florida, United States
FXM Research Miramar
Miramar, Florida, United States
South Tampa, MOORE Clinical Research, Inc.
Tampa, Florida, United States
North Tampa MOORE Clinical Research, Inc.
Tampa, Florida, United States
Medi Search
Saint Joseph, Missouri, United States
Bellaire Dermatology Associates
Bellaire, Texas, United States
Research Across America
Dallas, Texas, United States
...and 4 more locations