Clinical trial NCT03897257: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tinea Pedis
Lead sponsor: Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-04-01
Enrollment: 240
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Complete Cure at End of Study
timeFrame: Day 43
Secondary outcomes:
measure: Effective treatment
timeFrame: Day 43
measure: Mycological Cure
timeFrame: Day 43
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Site 03
state: California
city: Melbourne
country: United States
facility: Site 12
state: Florida
city: Miami
country: United States
facility: Site 06
state: Florida
city: North Miami Beach
country: United States
facility: Site 09
state: Florida
city: Rolling Meadows
country: United States
facility: Site 07
state: Illinois
city: Fridley
country: United States
facility: Site 11
state: Minnesota
city: Rochester
country: United States
facility: Site 04
state: New York
city: Austin
country: United States
facility: Site 01
state: Texas
city: Houston
country: United States
facility: Site 02
state: Texas
city: San Antonio
country: United States
facility: Site 10
state: Texas
city: Norfolk
country: United States
facility: Site 05
state: Virginia
city: Cidra
country: Puerto Rico
facility: Site 08
Study officials:
affiliation: Therapeutics, Inc.
name: Marietta Radona, MD
role: PRINCIPAL_INVESTIGATOR
References: