A Multicenter, Randomized, Double-Blinded, Parallel Group Comparison Study of the Safety and Efficacy of UHE-103 in Subjects With Moccasin-Type Tinea Pedis
Overview
- Phase
- Phase 2
- Intervention
- UHE-103A1 cream
- Conditions
- Tinea Pedis
- Sponsor
- Therapeutics, Inc.
- Enrollment
- 240
- Locations
- 12
- Primary Endpoint
- Complete Cure at End of Study
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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).
Investigators
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.
Arms & Interventions
UHE-103A1 cream
Topical cream applied twice daily for 2 weeks.
Intervention: UHE-103A1 cream
UHE-103A2 cream
Topical cream applied twice daily for 2 weeks.
Intervention: UHE-103A2 cream
UHE-103B cream
Topical cream applied twice daily for 2 weeks.
Intervention: UHE-103B cream
UHE-103A1B cream
Topical cream applied twice daily for 2 weeks.
Intervention: UHE-103A1B cream
UHE-103A2B cream
Topical cream applied twice daily for 2 weeks.
Intervention: UHE-103A2B cream
Outcomes
Primary Outcomes
Complete Cure at End of Study
Time Frame: Day 43
Proportion of subjects with Complete Cure (negative fungal test \& no clinical disease-induced signs and symptoms) at end of study (EOS).
Secondary Outcomes
- Effective treatment(Day 43)
- Mycological Cure(Day 43)