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

Purpose

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.

Condition	Intervention	Phase
Tinea Pedis	Drug: W0027 Drug: Placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Athlete's Foot Tinea Infections

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

The primary objective of this study is to assess the subject response to three W0027 regimens in subjects with MTTP. [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: 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) ] [ Designated as safety issue: No ]

Enrollment:	120
Study Start Date:	July 2007
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 W0027	Drug: W0027 capsule
Experimental: 2 W0027	Drug: W0027 capsule
Experimental: 3 W0027	Drug: W0027 capsule
Placebo Comparator: 4 Placebo	Drug: Placebo Placebo

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00509275

Locations

United States, Kentucky
Dermatology Specialists
Louisville, Kentucky, United States, 40202
United States, Michigan

Warren, Michigan, United States, 48088
United States, New Mexico

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

Sponsors and Collaborators

Stiefel, a GSK Company

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

More Information

No publications provided

Responsible Party:	Cheri A. Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00509275 History of Changes
Other Study ID Numbers:	W0027-08
Study First Received:	July 30, 2007
Last Updated:	July 12, 2011
Health Authority:	United States: Food and Drug Administration Canada: Health Canada Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:

Tinea
Tinea Pedis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses

Skin Diseases
Foot Dermatoses
Foot Diseases
Pruritus
Skin Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 17, 2012