Tinea Pedis
Conditions
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).
Interventions
DRUGUHE-103A1 cream
Investigational mono-therapy cream (containing drug A \[low dose\]). Drug A is an antifungal agent.
DRUGUHE-103A2 cream
Investigational mono-therapy cream (containing drug A \[low dose\]). Drug A is an antifungal agent.
DRUGUHE-103B cream
Comparator mono-therapy cream (containing drug B). Drug B is a keratolytic agent.
DRUGUHE-103A1B cream
Investigational combination-therapy cream (containing drug A \[low dose antifungal\] + drug B \[keratolytic\]).
DRUGUHE-103A2B cream
Investigational combination-therapy cream (containing drug A \[high dose antifungal\] + drug B \[keratolytic\]).
Sponsors
Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Puerto Rico, United States
Outcome results
None listed