A Study Comparing the Efficacy of TA103 and the Placebo Control in the Treatment of Interdigital Tinea Pedis.

Taro Pharmaceuticals

Status and phase: Completed; Early Phase 1

Conditions: Tinea Pedis

Treatments: Drug: Placebo Control; Drug: TA103

Study type: Interventional

Funder types: Industry

Identifiers

NCT04883593

TA103-2004

Details and patient eligibility

About

To evaluate and compare the safety and efficacy of TA103 in the treatment of tinea pedis.

Full description

A multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing TA103 and the placebo control in the treatment of tinea pedis.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or non pregnant female aged ≥ 18 years
• Subjects must have provided IRB approved written informed consent
• Subjects must have clinical diagnosis of interdigital tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot (the non-interdigital lesions should not be hyperkeratotic, i.e., characteristic of tinea pedis moccasin).

Exclusion criteria

• Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
• Subjects with a history of hypersensitivity or allergy to any of the study medication ingredients and its excipients.
• Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

160 participants in 2 patient groups, including a placebo group

TA103

Experimental group

Description:

The assigned Investigational Product will be applied to the skin between, under, all over the toes, sole and sides of the entire foot. Both feet are to be treated in the same way, even if the skin looks healthy and lesions are present on one foot only.

Treatment:

Drug: TA103

Placebo Control

Placebo Comparator group

Description:

The assigned Investigational Product will be applied to the skin between, under, all over the toes, sole and sides of the entire foot. Both feet are to be treated in the same way, even if the skin looks healthy and lesions are present on one foot only.

Treatment:

Drug: Placebo Control