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NCT03897257 Clinical Trial

A Comparison Study of UHE-103 Cream in Subjects With Moccasin Type Tinea Pedis

Tinea Pedis Clinical Trial

Official title:
A Multicenter, Randomized, Double-Blinded, Parallel Group Comparison Study of the Safety and Efficacy of UHE-103 in Subjects With Moccasin-Type Tinea Pedis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03897257
Other study ID # 146-9252-201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 15, 2019
Est. completion date May 5, 2020

Study information
Verified date October 2021
Source Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study is being done to determine and compare the safety and effectiveness of an investigational combination therapy (low and high concentrations) versus mono-therapy (low and high concentrations) or mono-therapy (fixed concentration) in subjects with moccasin type tinea pedis.

Description:

UHE-103 cream is an investigational combination drug to treat moccasin type tinea pedis, a fungal infection that affects the feet and toes. Eligible subjects will be assigned to one of the 5 possible treatment groups and participate for a total of 6 weeks. Subjects will apply their assigned test drug twice daily for 2 weeks. Each subject will then be assessed for safety and efficacy at week 4 and week 6. There will be a total of 5 clinic visits: 1 screening/baseline visit (Day 1), 2 treatment visits (Days 8 and 15), and 2 follow-up visits (Days 29 and 43).

Recruitment information / eligibility
Status Completed
Enrollment 240
Est. completion date May 5, 2020
Est. primary completion date October 21, 2019
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: - Male or non-pregnant female, 16 years of age or older. - Clinical diagnosis of moccasin type tinea pedis - Microscopic evidence (positive KOH) of the presence of fungi - Provided written informed consent/assent - In general good health Exclusion Criteria: - Pregnant or lactating or planning to get pregnant while on the study - Has concurrent tinea infection (e.g., tinea versicolor, tinea cruris) - Other skin disease which might interfere with the evaluation of tinea pedis - History of diabetes mellitus or is immunocompromised - Currently enrolled in an investigational drug or device study - Used an investigational drug or investigational device treatment within 30 days prior to Visit 1 (Study Day 1)/Baseline Other protocol defined inclusion or exclusion criteria assessed by the study staff may apply.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• UHE-103A1 cream
Investigational mono-therapy cream (containing drug A [low dose]). Drug A is an antifungal agent.
• UHE-103A2 cream
Investigational mono-therapy cream (containing drug A [low dose]). Drug A is an antifungal agent.
• UHE-103B cream
Comparator mono-therapy cream (containing drug B). Drug B is a keratolytic agent.
• UHE-103A1B cream
Investigational combination-therapy cream (containing drug A [low dose antifungal] + drug B [keratolytic]).
• UHE-103A2B cream
Investigational combination-therapy cream (containing drug A [high dose antifungal] + drug B [keratolytic]).

Locations
Country Name City State
Puerto Rico Site 08 Cidra
United States Site 01 Austin Texas
United States Site 11 Fridley Minnesota
United States Site 02 Houston Texas
United States Site 12 Melbourne Florida
United States Site 06 Miami Florida
United States Site 05 Norfolk Virginia
United States Site 09 North Miami Beach Florida
United States Site 04 Rochester New York
United States Site 07 Rolling Meadows Illinois
United States Site 10 San Antonio Texas
United States Site 03 San Diego California

Sponsors (1)
Lead Sponsor Collaborator
Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Complete Cure at End of Study Proportion of subjects with Complete Cure (negative fungal test & no clinical disease-induced signs and symptoms) at end of study (EOS). Day 43
Secondary Effective treatment Proportion of subjects with Effective Treatment (negative fungal test & no to mild clinical disease-induced signs and symptoms) at EOS. Day 43
Secondary Mycological Cure Proportion of subjects with Mycological Cure (negative fungal test) at EOS. Day 43
See also
  Status Clinical Trial Phase
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Completed NCT04883593 - A Study Comparing the Efficacy of TA103 and the Placebo Control in the Treatment of Interdigital Tinea Pedis. Early Phase 1
Terminated NCT02842021 - Efficacy and Safety of Product S2G6T-1in Patients With Symptomatic Inflammatory Interdigital Tinea Pedis Phase 2
Completed NCT01712360 - Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis Phase 4
Completed NCT00781664 - Cumulative Irritation Test Phase 1
Completed NCT03676686 - Study With Nåva Foot Cream in Patients With Tinea Pedis Interdigitalis N/A
Completed NCT01519752 - A Therapeutic Equivalence Study of Two Oxiconazole Nitrate Topical Cream Treatments for Patients With Tinea Pedis Phase 1
Completed NCT03320486 - Non-inferiority Trial of Dapaconazole Versus Ketoconazole Phase 3
Completed NCT01580891 - Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis Phase 1
Completed NCT01353976 - Safety and Efficacy of Econazole Nitrate Foam 1% in Subjects With Tinea Pedis Phase 3
Completed NCT01349998 - Safety of a Topical Antifungal Treatment for Tinea Cruris, Tinea Pedis and Tinea Corporis Phase 3
Completed NCT04265521 - Study With BioCool Footcare in Subjects With Tinea Pedis Interdigitalis and Heel Cracks, Calluses and/or Dry Feet N/A
Completed NCT02633813 - BE Study of Naftifine HCL Phase 3
Recruiting NCT00856596 - Once a Day Topical Treatment for Athlete's Foot Fungus Inbetween the Toes in Males and Females Phase 3
Completed NCT00869336 - Multicenter Study of the Efficacy and Safety of Luliconazole Cream in Tinea Pedis (Athlete's Foot) Phase 2
Completed NCT00768599 - A Study of Econazole Foam 1% in Athlete's Foot Phase 2
Recruiting NCT00233493 - Spread of Dermatophytes Among Families N/A
Completed NCT03129321 - Therapeutic Equivalence and Safety of Two Econazole Nitrate Cream, 1% Products in Tinea Pedis Phase 3
Completed NCT02335255 - Evaluate Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® Gel 2% in Tinea Pedis Phase 1
Withdrawn NCT02606383 - Non-inferiority Phase III Trial Comparing Dapaconazole Cream 2% With Ketoconazole Cream 2% in Patients With Tinea Pedis Phase 3