A Study to Evaluate Efficacy and Safety of Three W0027 Regimens in the Treatment of Moccasin Type Tinea Pedis (MTTP)
NCT ID: NCT00509275
Last Updated: 2017-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
120 participants
INTERVENTIONAL
2007-07-31
2008-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of Terbinafine Film Forming Solution in Patients With Tinea Pedis
NCT01433107
Topical Antifungal Treatment for Tinea Pedis
NCT01396785
Multicenter Study of the Safety and Efficacy of NAFT-500 in Tinea Pedis
NCT00750139
Topical Antifungal Treatment for Tinea Pedis
NCT01396811
Three-Arm Trial of Novel Treatment for Tinea Pedis
NCT03135912
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
W0027
W0027
capsule
2
W0027
W0027
capsule
3
W0027
W0027
capsule
4
Placebo
Placebo
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
W0027
capsule
Placebo
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Females of childbearing potential must use contraceptive methods .
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GlaxoSmithKline
INDUSTRY
Stiefel, a GSK Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lynda Spelman, MD
Role: PRINCIPAL_INVESTIGATOR
South East Dermatology, South East Dermatology, Carina QLD 4152, Australia
Michael Freeman, MD
Role: PRINCIPAL_INVESTIGATOR
The Skin Centre, Benowa QLD 4217, Australia
Peter Foley, MD
Role: PRINCIPAL_INVESTIGATOR
Skin and Cancer Foundation, Carlton VIC 3053 , Australia
Stephen Shumack, MD
Role: PRINCIPAL_INVESTIGATOR
St George Dermatology and Skin Cancer Centre, Kogarah NSW 2217, Australia
Warren Weightman, MD
Role: PRINCIPAL_INVESTIGATOR
Dermatology on Ward, North Adelaide SA 5006, Australia
Debra Breneman, MD
Role: PRINCIPAL_INVESTIGATOR
University Dermatology Consultants, Inc., Cincinnati, OH, 45219, US
Eduardo Tschen, MD
Role: PRINCIPAL_INVESTIGATOR
Albuquerque, NM 87106, US
Yves Poulin, MD
Role: PRINCIPAL_INVESTIGATOR
Centre de Dermatologie de Québec Métropolitain, Quebec, QC, G1V 4X7, Canada
David Gratton, MD
Role: PRINCIPAL_INVESTIGATOR
International Dermatology Research Inc., Montreal, QC, H3H 1V4, Canada
Wayne Gulliver Gulliver, MD
Role: PRINCIPAL_INVESTIGATOR
NewLab Clinical Research, St. John's, NF, A1B 3E1, Canada
Steven Grekin, MD
Role: PRINCIPAL_INVESTIGATOR
13450 East 12 Mile Road, Warren, MI 48088, US
Joseph Fowler, MD
Role: PRINCIPAL_INVESTIGATOR
Dermatology Specialists, 501 South Second Street, Louisville, KY 40202, US
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dermatology Specialists
Louisville, Kentucky, United States
Warren, Michigan, United States
Albuquerque, New Mexico, United States
University Dermatology Consultants, Inc.
Cincinnati, Ohio, United States
St George Dermatology and Skin Cancer Centre
Kogarah, New South Wales, Australia
The Skin Centre
Benowa, Queensland, Australia
South East Dermatology
Carina, Queensland, Australia
Dermatology on Ward
North Adelaide, South Australia, Australia
Skin and Cancer Foundation
Carlton, Victoria, Australia
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
W0027-08
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.