This is a study of the safety and efficacy of Econazole Nitrate Foam 1% and the Foam Vehicle in subjects with interdigital tinea pedis (athlete's foot between the toes). This is a 6 week study which has a 4 week treatment period and a 2 week follow-up evaluation. The study will also utilize Econazole Nitrate Cream 1% (for safety comparison) and a Placebo cream for blinding purposes only.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
336
Econazole Nitrate Foam 1% applied once a day for 4 weeks
Vehicle Foam applied once a day for 4 week
Econazole Nitrate Foam 1% applied once a day for 4 weeks
Sunil S. Dhawan, MD
Fremont, California, United States
Guy F. Webster, MD, PhD
Hockessin, Delaware, United States
Marta I. Rendon, MD
Boca Raton, Florida, United States
Complete Cure
Complete Cure is defined as a negative KOH and negative fungal culture and no evidence of clinical disease as indicated by scores of 0 (none) for each sign and system at Day 43, analysis of the Econazole Nitrate Foam 1% and Foam Vehicle treatment groups only.
Time frame: Day 43
Effective Treatment
Effective Treatment defined as negative KOH, negative fungal culture, no or mild (a score of 0 or 1) erythema and/or scaling with all other signs or symptoms being absent (score = 0) at Day 43, analysis of the Econazole Nitrate Foam 1% and Foam Vehicle treatment groups only.
Time frame: Day 43
Mycological Cure
Mycological Cure defined as negative KOH and negative culture at Day 43, analysis of the Econazole Nitrate Foam 1% and Foam Vehicle treatment groups only.
Time frame: Day 43
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Placebo cream applied once a day for 4 weeks
Jonathan Kantor, MD
Jacksonville, Florida, United States
Steven E. Kempers, MD
Fridley, Minnesota, United States
Joel Schlessinger, MD
Omaha, Nebraska, United States
Phoebe Rich, MD
Portland, Oregon, United States
Edward J. Primka III, MD
Knoxville, Tennessee, United States
Michael T. Jarratt, MD
Austin, Texas, United States
William Abramovits, MD
Dallas, Texas, United States
...and 2 more locations