A Study to Evaluate Efficacy and Safety of Three W0027 Regimens in the Treatment of Moccasin Type Tinea Pedis (MTTP)

Completed · Phase 1 · Has a placebo group

Conditions studied: Tinea Pedis

In brief

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.

Key facts

Study ID

NCT00509275

Run by

Stiefel, a GSK Company

People needed

120

Starts

2007-07-01

Expected to finish

2008-08-01

Last updated by the study team

2017-05-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 .

You may not qualify if…

• 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.

Where it is running

• Dermatology Specialists — Louisville, Kentucky, United States
• Study site — Warren, Michigan, United States
• Study site — Albuquerque, New Mexico, United States
• University Dermatology Consultants, Inc. — Cincinnati, Ohio, United States
• St George Dermatology and Skin Cancer Centre — Kogarah, New South Wales, Australia
• The Skin Centre — Benowa, Queensland, Australia
• South East Dermatology — Carina, Queensland, Australia
• Dermatology on Ward — North Adelaide, South Australia, Australia
• Skin and Cancer Foundation — Carlton, Victoria, Australia

Full record on ClinicalTrials.gov

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