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Sponsored by: |
Quinnova Pharmaceuticals, Inc. |
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Information provided by: | Quinnova Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00768599 |
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.
Condition | Intervention | Phase |
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Tinea Pedis Athlete's Foot |
Drug: Econazole Nitrate Cream 1% Drug: Econazole Nitrate Foam 1% Drug: Vehicle Foam |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center Randomized, Evaluator-Blinded, Vehicle Controlled, Parallel Group Comparison Study of the Safety and Efficacy of Econazole Nitrate Foam 1%, Econazole Nitrate 1% Cream, and Foam Vehicle in Subjects With Tinea Pedis |
Enrollment: | 135 |
Study Start Date: | March 2008 |
Study Completion Date: | October 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Econazole Nitrate Cream 1%
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Drug: Econazole Nitrate Cream 1%
Topical cream, applied once daily for 4 weeks.
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2: Experimental
Econazole Nitrate Foam 1%
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Drug: Econazole Nitrate Foam 1%
Topical foam, applied once daily for 4 weeks.
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3: Placebo Comparator
Vehicle Foam
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Drug: Vehicle Foam
Topical foam, applied once daily for 4 weeks.
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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).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Stacy Smith, MD | |
San Diego, California, United States, 92123 | |
United States, Michigan | |
Daniel Stewart, DO | |
Clinton Township, Michigan, United States, 48038 | |
United States, Minnesota | |
Steven Kempers, MD | |
Fridley, Minnesota, United States, 55432 | |
United States, Tennessee | |
Michael Gold, MD | |
Nashville, Tennessee, United States, 37215 | |
United States, Texas | |
Michael Jarratt, MD | |
Austin, Texas, United States, 78759 | |
United States, Utah | |
Leonard Swinyer, MD | |
Salt Lake City, Utah, United States, 84124 |
Responsible Party: | Quinnova Pharmaceuticals ( David Miska, Ph.D., Senior Director, Clinical and Regulatory Affairs ) |
Study ID Numbers: | D79-2902-07 |
Study First Received: | October 7, 2008 |
Last Updated: | October 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00768599 |
Health Authority: | United States: Food and Drug Administration |
Econazole Foam Quinnova |
Pruritus Skin Diseases Clotrimazole Miconazole Tioconazole Foot Diseases Tinea Pedis |
Mycoses Signs and Symptoms Skin Diseases, Infectious Econazole Tinea Dermatomycoses |
Anti-Infective Agents Skin Manifestations Foot Dermatoses Therapeutic Uses |
Antifungal Agents Infection Pharmacologic Actions |