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Sponsored by: |
Topica Pharmaceuticals, Inc. |
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Information provided by: | Topica Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00869336 |
To examine the safety and optimal duration of Luliconazole Cream 1% treatments for 14 days or 28 days to achieve "complete clearance" at 2 weeks post treatment.
Condition | Intervention | Phase |
---|---|---|
Tinea Pedis |
Drug: Luliconazole Cream 1% - 2 wks Drug: Placebo Comparator -2 wks Drug: Luliconazole Cream 1% - 4 wks Drug: Placebo Comparator - 4 wks |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 2 Study - A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Duration Finding Study Evaluating the Efficacy and Safety of Two Week and Four Week Once Daily Treatment of Luliconazole Cream 1% in Patients With Tinea Pedis |
Estimated Enrollment: | 150 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Luliconazole Cream 1% - 2 wks: Experimental |
Drug: Luliconazole Cream 1% - 2 wks
Topical cream applied daily for 2 weeks
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Luliconazole Cream 1% - 4 wks: Experimental |
Drug: Luliconazole Cream 1% - 4 wks
Topical cream applied daily for 4 weeks
|
Placebo Comparator - 2 wks: Placebo Comparator |
Drug: Placebo Comparator -2 wks
Placebo cream applied daily for 2 weeks
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Placebo Comparator - 4 wks: Placebo Comparator |
Drug: Placebo Comparator - 4 wks
Placebo cream applied daily for 4 weeks
|
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Subjects using the following medications:
Contact: Kathleen O. Ashenfelter, MS | 973 331 1620 | kashenfelter@cu-tech.com |
United States, Minnesota | |
Recruiting | |
Fridley, Minnesota, United States, 55432 | |
United States, Oregon | |
Recruiting | |
Portland, Oregon, United States, 97210 | |
United States, Texas | |
Recruiting | |
College Station, Texas, United States, 77840 | |
Recruiting | |
Austin, Texas, United States, 78759 |
Responsible Party: | Topica Pharmaceuticals, Inc. ( Topical Pharmaceuticals, Inc. ) |
Study ID Numbers: | TP-0801 |
Study First Received: | March 25, 2009 |
Last Updated: | April 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00869336 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Tinea Pedis Athlete's Foot |
Pruritus Mycoses Signs and Symptoms Tinea Pedis Skin Diseases, Infectious |
Skin Diseases Foot Diseases Tinea Dermatomycoses |
Pruritus Signs and Symptoms Skin Manifestations Mycoses Tinea Pedis Skin Diseases, Infectious |
Foot Dermatoses Skin Diseases Foot Diseases Infection Tinea Dermatomycoses |