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

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.

Conditions

• Tinea Pedis

Interventions

DRUG

W0027

capsule

DRUG

Placebo

Placebo

Sponsors & Collaborators

• GlaxoSmithKline

  collaborator INDUSTRY

• Stiefel, a GSK Company

  lead INDUSTRY

Principal Investigators

• Lynda Spelman, MD · South East Dermatology, South East Dermatology, Carina QLD 4152, Australia

• Michael Freeman, MD · The Skin Centre, Benowa QLD 4217, Australia

• Peter Foley, MD · Skin and Cancer Foundation, Carlton VIC 3053 , Australia

• Stephen Shumack, MD · St George Dermatology and Skin Cancer Centre, Kogarah NSW 2217, Australia

• Warren Weightman, MD · Dermatology on Ward, North Adelaide SA 5006, Australia

• Debra Breneman, MD · University Dermatology Consultants, Inc., Cincinnati, OH, 45219, US

• Eduardo Tschen, MD · Albuquerque, NM 87106, US

• Yves Poulin, MD · Centre de Dermatologie de Québec Métropolitain, Quebec, QC, G1V 4X7, Canada

• David Gratton, MD · International Dermatology Research Inc., Montreal, QC, H3H 1V4, Canada

• Wayne Gulliver Gulliver, MD · NewLab Clinical Research, St. John's, NF, A1B 3E1, Canada

• Steven Grekin, MD · 13450 East 12 Mile Road, Warren, MI 48088, US

• Joseph Fowler, MD · Dermatology Specialists, 501 South Second Street, Louisville, KY 40202, US

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-07-31

Primary Completion

2008-08-31

Completion

2008-08-31

Countries

• United States
• Australia

Study Locations