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

Primary Purpose

Tinea Pedis

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

W0027

Placebo

About this trial

This is an interventional treatment trial for Tinea Pedis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Dermatology Specialists
University Dermatology Consultants, Inc.
St George Dermatology and Skin Cancer Centre
The Skin Centre
South East Dermatology
Dermatology on Ward
Skin and Cancer Foundation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

W0027

Placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00509275

First Posted

July 30, 2007

Last Updated

May 24, 2017

Sponsor

Stiefel, a GSK Company

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00509275

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Stiefel, a GSK Company

Collaborators

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tinea Pedis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

W0027

Arm Title

Arm Type

Experimental

Arm Description

W0027

Arm Title

Arm Type

Experimental

Arm Description

W0027

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

W0027

Intervention Description

capsule

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials: