Clinical trial NCT00509275: A Study to Evaluate Efficacy and Safety of Three W0027 Regimens in the Treatment of Moccasin Type Tinea Pedis (MTTP)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tinea Pedis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2007-07-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: The primary objective of this study is to assess the subject response to three W0027 regimens in subjects with MTTP.
timeFrame: Week 8
Secondary outcomes:
measure: 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.
timeFrame: 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)
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Dermatology Specialists
state: Kentucky
city: Warren
country: United States
state: Michigan
city: Albuquerque
country: United States
state: New Mexico
city: Cincinnati
country: United States
facility: University Dermatology Consultants, Inc.
state: Ohio
city: Kogarah
country: Australia
facility: St George Dermatology and Skin Cancer Centre
state: New South Wales
city: Benowa
country: Australia
facility: The Skin Centre
state: Queensland
city: Carina
country: Australia
facility: South East Dermatology
state: Queensland
city: North Adelaide
country: Australia
facility: Dermatology on Ward
state: South Australia
city: Carlton
country: Australia
facility: Skin and Cancer Foundation
state: Victoria
Study officials:
affiliation: South East Dermatology, South East Dermatology, Carina QLD 4152, Australia
name: Lynda Spelman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Skin Centre, Benowa QLD 4217, Australia
name: Michael Freeman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Skin and Cancer Foundation, Carlton VIC 3053 , Australia
name: Peter Foley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St George Dermatology and Skin Cancer Centre, Kogarah NSW 2217, Australia
name: Stephen Shumack, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology on Ward, North Adelaide SA 5006, Australia
name: Warren Weightman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Dermatology Consultants, Inc., Cincinnati, OH, 45219, US
name: Debra Breneman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Albuquerque, NM 87106, US
name: Eduardo Tschen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre de Dermatologie de Québec Métropolitain, Quebec, QC, G1V 4X7, Canada
name: Yves Poulin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Dermatology Research Inc., Montreal, QC, H3H 1V4, Canada
name: David Gratton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NewLab Clinical Research, St. John's, NF, A1B 3E1, Canada
name: Wayne Gulliver Gulliver, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 13450 East 12 Mile Road, Warren, MI 48088, US
name: Steven Grekin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology Specialists, 501 South Second Street, Louisville, KY 40202, US
name: Joseph Fowler, MD
role: PRINCIPAL_INVESTIGATOR
References: