A Study to Evaluate Efficacy and Safety of Three W0027 Regimens in the Treatment of Moccasin Type Tinea Pedis (MTTP)
- Registration Number
- NCT00509275
- Lead Sponsor
- Stiefel, a GSK Company
- Brief Summary
In this phase Ib, multi-centre, randomized, double-blind, placebo-controlled parallel group study, 120 subjects with moccasin type tinea pedis (MTTP) will be enrolled at approximately 11 centres in the USA, Canada and Australia.
The primary objective of the study is to assess the patient response to three W0027 regimens in subjects with MTTP. Secondary objectives include assessment of the safety, tolerability and skin and nail pharmacokinetics to the three Albaconazole regimens.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Subjects aged 18-65 years, who have been diagnosed with moccasin type tinea pedis (by positive dermatophyte culture, positive potassium hydroxide/calcofluor white preparation, and a Total Signs and Symptoms Score of at least 4).
- Females of childbearing potential must use contraceptive methods .
- Subjects who are receiving any CYP3A substrates with potential for QT prolongation;
- have used systemic antifungal drugs within 30 days of first dose; or topical antifungals within 2 weeks of first dose.
- Also excluded are those who have a clinically significant medical condition.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 W0027 W0027 3 W0027 W0027 4 Placebo Placebo 1 W0027 W0027
- Primary Outcome Measures
Name Time Method The primary objective of this study is to assess the subject response to three W0027 regimens in subjects with MTTP. Week 8
- Secondary Outcome Measures
Name Time Method The secondary objectives of this study are: To assess the safety and tolerability of three W0027 regimens in subjects with MTTP; To assess skin and nail pharmacokinetics of three Albaconazole doses in subjects with MTTP. Skin and Plasma samples Week 0 (Visit 2) through to Week 8 (Visit 9), Nail samples Week 0 (Visit 2) Week 4(Visit 7) and Week 8(Visit 9)
Trial Locations
- Locations (7)
University Dermatology Consultants, Inc.
🇺🇸Cincinnati, Ohio, United States
Dermatology Specialists
🇺🇸Louisville, Kentucky, United States
South East Dermatology
🇦🇺Carina, Queensland, Australia
Dermatology on Ward
🇦🇺North Adelaide, South Australia, Australia
Skin and Cancer Foundation
🇦🇺Carlton, Victoria, Australia
St George Dermatology and Skin Cancer Centre
🇦🇺Kogarah, New South Wales, Australia
The Skin Centre
🇦🇺Benowa, Queensland, Australia