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. 2012 Oct 17;2012(10):CD003584. doi: 10.1002/14651858.CD003584.pub2

NCT00509275.

Trial name or 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
Methods In this phase Ib, multicentre, randomised, double‐blind, placebo‐controlled parallel‐group study, 120 participants with moccasin type tinea pedis (MTTP) will be enrolled at approximately 11 centres in the US, Canada, and Australia. The primary objective of the study is to assess the participant response to 3 W0027 regimens in subjects with MTTP. Secondary objectives include assessment of the safety, tolerability, and skin and nail pharmacokinetics to the 3 Albaconazole regimens.
Participants
  • 120 subjects with moccasin type tinea pedis

Interventions
  • 3 different doses of W0027 and placebo

Outcomes Primary outcomes of the trial
  1. To assess the subject response to 3 W0027 regimens in subjects with MTTP (time frame: week 8)


Secondary outcomes of the trial
  1. To assess the safety and tolerability of 3 W0027 regimens in subjects with MTTP

  2. To assess skin and nail pharmacokinetics of 3 Albaconazole doses in subjects with MTTP

Starting date July 2007 (Completed)
Contact information Lynda Spelman, MD, Principal Investigator, South East Dermatology, South East Dermatology, Carina QLD 4152, Australia
 Michael Freeman, MD, Principal Investigator, The Skin Centre, Benowa QLD 4217, Australia
 Peter Foley, MD, Principal Investigator, Skin and Cancer Foundation, Carlton VIC 3053, Australia
 Stephen Shumack, MD, Principal Investigator, St George Dermatology and Skin Cancer Centre, Kogarah NSW 2217, Australia
 Warren Weightman, MD, Principal Investigator, Dermatology on Ward, North Adelaide SA 5006, Australia
 Debra Breneman, MD, Principal Investigator, University Dermatology Consultants, Inc., Cincinnati, OH, 45219, US
 Eduardo Tschen, MD, Principal Investigator, Albuquerque, NM 87106, US
 Yves Poulin, MD, Principal Investigator, Centre de Dermatologie, Quebec, QC, G1V 4X7, Canada
 David Gratton, MD, Principal Investigator, International Dermatology Research Inc., Montreal, QC, H3H 1V4, Canada
 Wayne Gulliver Gulliver, MD, Principal Investigator, NewLab Clinical Research, St. John's, NF, A1B 3E1, Canada
 Steven Grekin, MD, Principal Investigator, 13450 East 12 Mile Road, Warren, MI 48088, US
 Joseph Fowler, MD, Principal Investigator, Dermatology Specialists, 501 South Second Street, Louisville, KY 40202, US
Notes The trial was sponsored by Stiefel, a GlaxoSmithKline (GSK) company.
We obtained information from http://clinicaltrials.gov/ on 2 February 2012. NCT00509275