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

NCT00509275 | Completed Phase 1

• 1 other identifier: W0027-08
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 9

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.

Conditions

Tinea Pedis

Outcome Measures

Primary Outcomes (1)

• The primary objective of this study is to assess the subject response to three W0027 regimens in subjects with MTTP.

  Week 8

Secondary Outcomes (1)

• 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)

Study Arms (4)

1

EXPERIMENTAL

W0027

Drug: W0027

2

EXPERIMENTAL

W0027

Drug: W0027

3

EXPERIMENTAL

W0027

Drug: W0027

4

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

W0027 DRUG

capsule

1; 2; 3

Placebo DRUG

Placebo

4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stiefel, a GSK Company: lead
• GlaxoSmithKline: collaborator

Study Sites (9)

Dermatology Specialists

Louisville, Kentucky, 40202, United States

Location

Unknown Facility

Warren, Michigan, 48088, United States

Location

Unknown Facility

Albuquerque, New Mexico, 87106, United States

Location

University Dermatology Consultants, Inc.

Cincinnati, Ohio, 45219, United States

Location

St George Dermatology and Skin Cancer Centre

Kogarah, New South Wales, NSW 2217, Australia

Location

The Skin Centre

Benowa, Queensland, QLD 4217, Australia

Location

South East Dermatology

Carina, Queensland, QLD 4152, Australia

Location

Dermatology on Ward

North Adelaide, South Australia, SA 5006, Australia

Location

Skin and Cancer Foundation

Carlton, Victoria, VIC 3053, Australia

Location

MeSH Terms

Conditions

Tinea Pedis

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Foot Dermatoses; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pruritus; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2007
• First Posted: July 31, 2007
• Study Start: July 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

US (4); AU (5)