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

Primary Purpose

Tinea Pedis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
UHE-103A1 cream
UHE-103A2 cream
UHE-103B cream
UHE-103A1B cream
UHE-103A2B cream
Sponsored by
Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinea Pedis

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Site 03
  • Site 12
  • Site 06
  • Site 09
  • Site 07
  • Site 11
  • Site 04
  • Site 01
  • Site 02
  • Site 10
  • Site 05
  • Site 08

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

UHE-103A1 cream

UHE-103A2 cream

UHE-103B cream

UHE-103A1B cream

UHE-103A2B cream

Arm Description

Topical cream applied twice daily for 2 weeks.

Topical cream applied twice daily for 2 weeks.

Topical cream applied twice daily for 2 weeks.

Topical cream applied twice daily for 2 weeks.

Topical cream applied twice daily for 2 weeks.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
March 28, 2019
Last Updated
October 26, 2021
Sponsor
Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03897257
Brief Title
A Comparison Study of UHE-103 Cream in Subjects With Moccasin Type Tinea Pedis
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 15, 2019 (Actual)
Primary Completion Date
October 21, 2019 (Actual)
Study Completion Date
May 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinea Pedis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UHE-103A1 cream
Arm Type
Experimental
Arm Description
Topical cream applied twice daily for 2 weeks.
Arm Title
UHE-103A2 cream
Arm Type
Experimental
Arm Description
Topical cream applied twice daily for 2 weeks.
Arm Title
UHE-103B cream
Arm Type
Experimental
Arm Description
Topical cream applied twice daily for 2 weeks.
Arm Title
UHE-103A1B cream
Arm Type
Experimental
Arm Description
Topical cream applied twice daily for 2 weeks.
Arm Title
UHE-103A2B cream
Arm Type
Experimental
Arm Description
Topical cream applied twice daily for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
UHE-103A1 cream
Intervention Description
Investigational mono-therapy cream (containing drug A [low dose]). Drug A is an antifungal agent.
Intervention Type
Drug
Intervention Name(s)
UHE-103A2 cream
Intervention Description
Investigational mono-therapy cream (containing drug A [low dose]). Drug A is an antifungal agent.
Intervention Type
Drug
Intervention Name(s)
UHE-103B cream
Intervention Description
Comparator mono-therapy cream (containing drug B). Drug B is a keratolytic agent.
Intervention Type
Drug
Intervention Name(s)
UHE-103A1B cream
Intervention Description
Investigational combination-therapy cream (containing drug A [low dose antifungal] + drug B [keratolytic]).
Intervention Type
Drug
Intervention Name(s)
UHE-103A2B cream
Intervention Description
Investigational combination-therapy cream (containing drug A [high dose antifungal] + drug B [keratolytic]).
Primary Outcome Measure Information:
Title
Complete Cure at End of Study
Description
Proportion of subjects with Complete Cure (negative fungal test & no clinical disease-induced signs and symptoms) at end of study (EOS).
Time Frame
Day 43
Secondary Outcome Measure Information:
Title
Effective treatment
Description
Proportion of subjects with Effective Treatment (negative fungal test & no to mild clinical disease-induced signs and symptoms) at EOS.
Time Frame
Day 43
Title
Mycological Cure
Description
Proportion of subjects with Mycological Cure (negative fungal test) at EOS.
Time Frame
Day 43

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marietta Radona, MD
Organizational Affiliation
Therapeutics, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Site 03
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Site 12
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32935
Country
United States
Facility Name
Site 06
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Site 09
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Site 07
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008
Country
United States
Facility Name
Site 11
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Site 04
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Site 01
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Site 02
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
Site 10
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Site 05
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Site 08
City
Cidra
ZIP/Postal Code
00739
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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