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

Sponsor
Stiefel, a GSK Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00509275
Collaborator
GlaxoSmithKline (Industry)
120
Enrollment
9
Locations
4
Arms
13
Duration (Months)
13.3
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, 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
Study Start Date :
Jul 1, 2007
Actual Primary Completion Date :
Aug 1, 2008
Actual Study Completion Date :
Aug 1, 2008

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. 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

  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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Dermatology Specialists Louisville Kentucky United States 40202
2 Warren Michigan United States 48088
3 Albuquerque New Mexico United States 87106
4 University Dermatology Consultants, Inc. Cincinnati Ohio United States 45219
5 St George Dermatology and Skin Cancer Centre Kogarah New South Wales Australia NSW 2217
6 The Skin Centre Benowa Queensland Australia QLD 4217
7 South East Dermatology Carina Queensland Australia QLD 4152
8 Dermatology on Ward North Adelaide South Australia Australia SA 5006
9 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stiefel, a GSK Company
ClinicalTrials.gov Identifier:
NCT00509275
Other Study ID Numbers:
  • W0027-08
First Posted:
Jul 31, 2007
Last Update Posted:
May 30, 2017
Last Verified:
May 1, 2017
Additional relevant MeSH terms:
Tinea
Tinea Pedis

Study Results

No Results Posted as of May 30, 2017