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

Tinea Pedis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00509275
• Other study ID #: W0027-08
• Status: Completed
• Phase: Phase 1
• First received: July 30, 2007
• Last updated: May 24, 2017
• Start date: July 2007
• Est. completion date: August 2008

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tinea
• Tinea Pedis

Intervention

Drug:
• W0027
capsule
• Placebo
Placebo

Locations

Country	Name	City	State
Australia	The Skin Centre	Benowa	Queensland
Australia	South East Dermatology	Carina	Queensland
Australia	Skin and Cancer Foundation	Carlton	Victoria
Australia	St George Dermatology and Skin Cancer Centre	Kogarah	New South Wales
Australia	Dermatology on Ward	North Adelaide	South Australia
United States	University Dermatology Consultants, Inc.	Cincinnati	Ohio
United States	Dermatology Specialists	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Stiefel, a GSK Company	GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective of this study is to assess the subject response to three W0027 regimens in subjects with MTTP.		Week 8
Secondary	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)