Trial | NCT00509275  Report issue

Title

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

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    120
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.
Study Started
Jul 31
2007
Primary Completion
Aug 31
2008
Study Completion
Aug 31
2008
Last Update
May 30
2017

Drug Placebo

Placebo

Drug W0027

capsule

1 Experimental

W0027

2 Experimental

W0027

3 Experimental

W0027

4 Placebo Comparator

Placebo

Criteria 

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.
No Results Posted