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

Sponsor

Therapeutics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03897257

Collaborator

(none)

240

Enrollment

Locations

Arms

13.7

Actual Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Tinea Pedis	Drug: UHE-103A1 cream Drug: UHE-103A2 cream Drug: UHE-103B cream Drug: UHE-103A1B cream Drug: UHE-103A2B cream	Phase 2

Detailed 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).

Study Design

Study Type:

Interventional

Actual Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Five Arms: 3 Arms of Monotherapy : UHE-103A1 cream (Drug A low dose concentration) or UHE-103A2 cream (Drug A high concentration) or UHE-103B cream (Drug B comparator) 2 Arms of combination therapy: UHE-103A1B cream (Drug A low dose + Drug B), or UHE-103A2B cream (Drug A high dose + Drug B)Five Arms:3 Arms of Monotherapy : UHE-103A1 cream (Drug A low dose concentration) or UHE-103A2 cream (Drug A high concentration) or UHE-103B cream (Drug B comparator) 2 Arms of combination therapy: UHE-103A1B cream (Drug A low dose + Drug B), or UHE-103A2B cream (Drug A high dose + Drug B)

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 15, 2019

Actual Primary Completion Date :

Oct 21, 2019

Actual Study Completion Date :

May 5, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: UHE-103A1 cream Topical cream applied twice daily for 2 weeks.	Drug: UHE-103A1 cream Investigational mono-therapy cream (containing drug A [low dose]). Drug A is an antifungal agent.
Experimental: UHE-103A2 cream Topical cream applied twice daily for 2 weeks.	Drug: UHE-103A2 cream Investigational mono-therapy cream (containing drug A [low dose]). Drug A is an antifungal agent.
Experimental: UHE-103B cream Topical cream applied twice daily for 2 weeks.	Drug: UHE-103B cream Comparator mono-therapy cream (containing drug B). Drug B is a keratolytic agent.
Experimental: UHE-103A1B cream Topical cream applied twice daily for 2 weeks.	Drug: UHE-103A1B cream Investigational combination-therapy cream (containing drug A [low dose antifungal] + drug B [keratolytic]).
Experimental: UHE-103A2B cream Topical cream applied twice daily for 2 weeks.	Drug: UHE-103A2B cream Investigational combination-therapy cream (containing drug A [high dose antifungal] + drug B [keratolytic]).

Outcome Measures

Primary Outcome Measures

Complete Cure at End of Study [Day 43]
Proportion of subjects with Complete Cure (negative fungal test & no clinical disease-induced signs and symptoms) at end of study (EOS).

Secondary Outcome Measures

Effective treatment [Day 43]
Proportion of subjects with Effective Treatment (negative fungal test & no to mild clinical disease-induced signs and symptoms) at EOS.
Mycological Cure [Day 43]
Proportion of subjects with Mycological Cure (negative fungal test) at EOS.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site 03	San Diego	California	United States	92123
2	Site 12	Melbourne	Florida	United States	32935
3	Site 06	Miami	Florida	United States	33144
4	Site 09	North Miami Beach	Florida	United States	33162
5	Site 07	Rolling Meadows	Illinois	United States	60008
6	Site 11	Fridley	Minnesota	United States	55432
7	Site 04	Rochester	New York	United States	14623
8	Site 01	Austin	Texas	United States	78759
9	Site 02	Houston	Texas	United States	77055
10	Site 10	San Antonio	Texas	United States	78229
11	Site 05	Norfolk	Virginia	United States	23502
12	Site 08	Cidra		Puerto Rico	00739

Sponsors and Collaborators

Therapeutics, Inc.

Investigators

Principal Investigator: Marietta Radona, MD, Therapeutics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT03897257

Other Study ID Numbers:

146-9252-201

First Posted:

Apr 1, 2019

Last Update Posted:

Oct 28, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Tinea

Tinea Pedis

Study Results

No Results Posted as of Oct 28, 2021