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

Stiefel, a GSK Company120 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Tinea Pedis

Interventions

W0027DRUG

capsule

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (9)

Dermatology Specialists

Louisville, Kentucky, United States

Unnamed facility

Warren, Michigan, United States

Unnamed facility

Albuquerque, New Mexico, United States

University Dermatology Consultants, Inc.

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

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

Time frame: Week 8

Secondary Outcomes

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.

Time frame: 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)

Data from ClinicalTrials.gov

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