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

Stiefel

Status and phase: Completed; Phase 1

Conditions: Tinea Pedis

Treatments: Drug: W0027; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00509275

W0027-08

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

120 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

W0027

Treatment:

Drug: W0027

2

Experimental group

Description:

W0027

Treatment:

Drug: W0027

3

Experimental group

Description:

W0027

Treatment:

Drug: W0027

4

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo