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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


Phase 1
18 Years
65 Years
Not Enrolling
Both
Tinea Pedis

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Week 8

Safety Issue:

No

Principal Investigator

Lynda Spelman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

South East Dermatology, South East Dermatology, Carina QLD 4152, Australia

Authority:

United States: Food and Drug Administration

Study ID:

W0027-08

NCT ID:

NCT00509275

Start Date:

July 2007

Completion Date:

August 2008

Related Keywords:

  • Tinea Pedis
  • Tinea
  • Tinea Pedis

Name

Location

Flint, Michigan  48532
Albuquerque, New Mexico  87131-5636
University Dermatology Consultants, Inc.Cincinnati, Ohio  45242
Dermatology SpecialistsLouisville, Kentucky  40202