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

A Phase Ib, Randomized, Double Blind, Placebo Controlled Study to Investigate the Pharmacokinetics, Safety and Efficacy of 3 Different Doses of W0027 and Placebo Capsules in Subjects With Clinically and Mycologically Proven MTTP

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.

Study Overview

• Status: Completed
• Conditions: Tinea Pedis
• Intervention / Treatment: Drug: Placebo; Drug: W0027

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, NSW 2217
      • St George Dermatology and Skin Cancer Centre
  • Queensland
    • Benowa, Queensland, Australia, QLD 4217
      • The Skin Centre
    • Carina, Queensland, Australia, QLD 4152
      • South East Dermatology
  • South Australia
    • North Adelaide, South Australia, Australia, SA 5006
      • Dermatology on Ward
  • Victoria
    • Carlton, Victoria, Australia, VIC 3053
      • Skin and Cancer Foundation
• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Dermatology Specialists
  • Michigan
    • Warren, Michigan, United States, 48088
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University Dermatology Consultants, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 .

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 4; Placebo	Drug: Placebo; Placebo
Experimental: 1; W0027	Drug: W0027; capsule
Experimental: 2; W0027	Drug: W0027; capsule
Experimental: 3; W0027	Drug: W0027; capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Stiefel, a GSK Company
• Collaborators: GlaxoSmithKline
• Investigators: Principal Investigator: Lynda Spelman, MD, South East Dermatology, South East Dermatology, Carina QLD 4152, Australia; Principal Investigator: Michael Freeman, MD, The Skin Centre, Benowa QLD 4217, Australia; Principal Investigator: Peter Foley, MD, Skin and Cancer Foundation, Carlton VIC 3053 , Australia; Principal Investigator: Stephen Shumack, MD, St George Dermatology and Skin Cancer Centre, Kogarah NSW 2217, Australia; Principal Investigator: Warren Weightman, MD, Dermatology on Ward, North Adelaide SA 5006, Australia; Principal Investigator: Debra Breneman, MD, University Dermatology Consultants, Inc., Cincinnati, OH, 45219, US; Principal Investigator: Eduardo Tschen, MD, Albuquerque, NM 87106, US; Principal Investigator: Yves Poulin, MD, Centre de Dermatologie de Québec Métropolitain, Quebec, QC, G1V 4X7, Canada; Principal Investigator: David Gratton, MD, International Dermatology Research Inc., Montreal, QC, H3H 1V4, Canada; Principal Investigator: Wayne Gulliver Gulliver, MD, NewLab Clinical Research, St. John's, NF, A1B 3E1, Canada; Principal Investigator: Steven Grekin, MD, 13450 East 12 Mile Road, Warren, MI 48088, US; Principal Investigator: Joseph Fowler, MD, Dermatology Specialists, 501 South Second Street, Louisville, KY 40202, US

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: July 30, 2007
• First Submitted That Met QC Criteria: July 30, 2007
• First Posted (Estimate): July 31, 2007

Study Record Updates

• Last Update Posted (Actual): May 30, 2017
• Last Update Submitted That Met QC Criteria: May 24, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Foot Diseases; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Skin Manifestations; Dermatomycoses; Foot Dermatoses; Pruritus; Tinea; Tinea Pedis
• Other Study ID Numbers: W0027-08