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

NCT04883593 | Completed Early Phase 1 FDA Drug

• 1 other identifier: TA103-2004
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tinea Pedis

Outcome Measures

Primary Outcomes (1)

• The proportion of subjects with complete cure at Week 6 (+/- 4 days) following treatment (study day 38-46)

  To evaluate safety and efficacy of TA103

  Baseline to Week 6 Visit

Study Arms (2)

TA103

EXPERIMENTAL

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.

Drug: TA103

Placebo Control

PLACEBO COMPARATOR

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.

Drug: Placebo Control

Interventions

TA103 DRUG

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.

Also known as: Test Product

TA103

Placebo Control DRUG

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.

Also known as: Vehicle

Placebo Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Pharmaceutical Industries, Inc.: lead

Study Sites (1)

Catawba Research, LLC

Charlotte, North Carolina, 28217, United States

Location

MeSH Terms

Conditions

Tinea Pedis

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Foot Dermatoses; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pruritus; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zaidoon A. Al-Zubaidy

  Catawba Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 12, 2021
• Study Start: September 3, 2020
• Primary Completion: February 20, 2021
• Study Completion: February 20, 2021
• Last Updated: May 12, 2021

Record last verified: 2021-05

Locations

US (1)