A Phase 2 interventional study of UHE-103A1 cream and UHE-103A2 cream in Tinea Pedis, sponsored by Therapeutics, Inc.. Completed at 12 sites in 2 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2021-10-28.
Sponsored by Therapeutics, Inc. · Phase 2, Interventional, and Treatment
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.
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).
73 studies on the registry are indexed under Tinea Pedis; 8 are open to participants now.
This study's enrollment of 240 is above the median of 128 across 66 interventional studies indexed under Tinea Pedis.
Browse Tinea Pedis studies →Therapeutics, Inc. is the lead sponsor of 17 studies on the registry; none are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other protocol defined inclusion or exclusion criteria assessed by the study staff may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Topical cream applied twice daily for 2 weeks.
Drug: UHE-103A1 cream
Topical cream applied twice daily for 2 weeks.
Drug: UHE-103A2 cream
Topical cream applied twice daily for 2 weeks.
Drug: UHE-103B cream
Topical cream applied twice daily for 2 weeks.
Drug: UHE-103A1B cream
Topical cream applied twice daily for 2 weeks.
Drug: UHE-103A2B cream
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 \[keratolytic\]).
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).
Time frame: Day 43
Effective treatment
Proportion of subjects with Effective Treatment (negative fungal test \& no to mild clinical disease-induced signs and symptoms) at EOS.
Time frame: Day 43
Mycological Cure
Proportion of subjects with Mycological Cure (negative fungal test) at EOS.
Time frame: Day 43
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Therapeutics, Inc.