This is a 6-week clinical study (4 weeks of treatment, once per day, plus a 2-week follow-up period) of a topical foam to treat athlete's foot. The active ingredient in the foam -- econazole nitrate 1% -- is the same active pharmaceutical ingredient in a cream that your doctor can currently prescribe to treat athlete's foot. This study will help to understand if the foam works the same as the cream to treat athlete's foot.
Treating athlete's foot with a cream can leave a greasy, wet feeling on the foot that is uncomfortable to the user and messy on clothing and foot wear. A foam formulation that spreads easily and rubs-in easily that is as effective as the (reference) cream formulation in treating athlete's foot would be a benefit to the user. This study is designed to substantiate a clinical bridge between econazole nitrate foam 1% and econazole nitrate cream 1% based on clinical outcome, safety, and pharmacokinetic data. The study is (foam) vehicle-controlled and is randomized 1 to 1 to 1 (foam:cream:vehicle).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
135
Topical cream, applied once daily for 4 weeks.
Topical foam, applied once daily for 4 weeks.
Topical foam, applied once daily for 4 weeks.
Stacy Smith, MD
San Diego, California, United States
Daniel Stewart, DO
Clinton Township, Michigan, United States
Steven Kempers, MD
Fridley, Minnesota, United States
Michael Gold, MD
Nashville, Tennessee, United States
Complete Cure Rate: Interdigital Disease
A negative KOH and negative culture and no evidence of clinical disease as indicated by scores of 0 for each sign and symptom at Day 43.
Time frame: Day 43
Complete Cure Rate: Moccasin Disease
A negative KOH and negative culture and no evidence of clinical disease as indicated by scores of 0 for each sign and symptom at Day 43.
Time frame: 43 Days
Effective Treatment: Interdigital Disease
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 (Week6).
Time frame: 43
Effective Treatment: Mocassin Disease
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 (Week6).
Time frame: 43
Mycological Cure: Interdigital Disease
Negative KOH and negative fungal culture at Day 43
Time frame: 43
Mycological Cure: Mocassin Disease
Negative KOH and negative fungal culture at Day 43
Time frame: 43
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Michael Jarratt, MD
Austin, Texas, United States
Leonard Swinyer, MD
Salt Lake City, Utah, United States