A Comparison Study of UHE-103 Cream in Subjects With Moccasin Type Tinea Pedis
A Multicenter, Randomized, Double-Blinded, Parallel Group Comparison Study of the Safety and Efficacy of UHE-103 in Subjects With Moccasin-Type Tinea Pedis
1 other identifier
interventional
240
2 countries
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2019
Shorter than P25 for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2019
CompletedFirst Submitted
Initial submission to the registry
March 28, 2019
CompletedFirst Posted
Study publicly available on registry
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2020
CompletedOctober 28, 2021
October 1, 2021
7 months
March 28, 2019
October 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Effective treatment
Day 43
Mycological Cure
Day 43
Study Arms (5)
UHE-103A1 cream
EXPERIMENTALTopical cream applied twice daily for 2 weeks.
UHE-103A2 cream
EXPERIMENTALTopical cream applied twice daily for 2 weeks.
UHE-103B cream
EXPERIMENTALTopical cream applied twice daily for 2 weeks.
UHE-103A1B cream
EXPERIMENTALTopical cream applied twice daily for 2 weeks.
UHE-103A2B cream
EXPERIMENTALTopical cream applied twice daily for 2 weeks.
Interventions
Investigational mono-therapy cream (containing drug A \[low dose\]). Drug A is an antifungal agent.
Investigational mono-therapy cream (containing drug A \[low dose\]). Drug A is an antifungal agent.
Comparator mono-therapy cream (containing drug B). Drug B is a keratolytic agent.
Investigational combination-therapy cream (containing drug A \[low dose antifungal\] + drug B \[keratolytic\]).
Investigational combination-therapy cream (containing drug A \[high dose antifungal\] + drug B \[keratolytic\]).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Site 03
San Diego, California, 92123, United States
Site 12
Melbourne, Florida, 32935, United States
Site 06
Miami, Florida, 33144, United States
Site 09
North Miami Beach, Florida, 33162, United States
Site 07
Rolling Meadows, Illinois, 60008, United States
Site 11
Fridley, Minnesota, 55432, United States
Site 04
Rochester, New York, 14623, United States
Site 01
Austin, Texas, 78759, United States
Site 02
Houston, Texas, 77055, United States
Site 10
San Antonio, Texas, 78229, United States
Site 05
Norfolk, Virginia, 23502, United States
Site 08
Cidra, 00739, Puerto Rico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marietta Radona, MD
Therapeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2019
First Posted
April 1, 2019
Study Start
March 15, 2019
Primary Completion
October 21, 2019
Study Completion
May 5, 2020
Last Updated
October 28, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share