Conditions: Tinea Pedis Athlete's Foot
Keywords: Econazole Foam Quinnova
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 135
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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).

Arms:
arm 1: Econazole Nitrate Cream 1% arm 2: Econazole Nitrate Foam 1% arm 3: Vehicle Foam

Interventions: intervention 1: Econazole Nitrate Cream 1% intervention 2: Econazole Nitrate Foam 1% intervention 3: Vehicle Foam
Intervention descriptions: intervention 1: Topical cream, applied once daily for 4 weeks. intervention 2: Topical foam, applied once daily for 4 weeks. intervention 3: Topical foam, applied once daily for 4 weeks.

Protocol document: