Tinea PedisPhase 2NCT03897257
A Comparison Study of UHE-103 Cream in Subjects With Moccasin Type Tinea Pedis
A Phase 2 study testing UHE-103A1 cream, UHE-103A2 cream and UHE-103B cream in people with Tinea Pedis, run by Therapeutics, Inc. at 12 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Tinea Pedis
- What is being tested?
- UHE-103A1 cream, UHE-103A2 cream and UHE-103B cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 15 Mar 2019to 5 May 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States11 sites
Site 01
Austin, Texas, 78759
Site 11
Fridley, Minnesota, 55432
Site 02
Houston, Texas, 77055
Site 12
Melbourne, Florida, 32935
Site 06
Miami, Florida, 33144
Site 05
Norfolk, Virginia, 23502
Site 09
North Miami Beach, Florida, 33162
Site 04
Rochester, New York, 14623
Site 07
Rolling Meadows, Illinois, 60008
Site 10
San Antonio, Texas, 78229
Site 03
San Diego, California, 92123
About this study
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
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.
Read the 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).
- Conditions
- Tinea Pedis
- Being tested
- UHE-103A1 cream, UHE-103A2 cream, UHE-103B cream, UHE-103A1B cream, UHE-103A2B cream
- Medical subject headings
- Tinea Pedis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UHE-103A1 creamDrug
Investigational mono-therapy cream (containing drug A [low dose]). Drug A is an antifungal agent.
UHE-103A2 creamDrug
Investigational mono-therapy cream (containing drug A [low dose]). Drug A is an antifungal agent.
UHE-103B creamDrug
Comparator mono-therapy cream (containing drug B). Drug B is a keratolytic agent.
UHE-103A1B creamDrug
Investigational combination-therapy cream (containing drug A [low dose antifungal] + drug B [keratolytic]).
UHE-103A2B creamDrug
Investigational combination-therapy cream (containing drug A [high dose antifungal] + drug B [keratolytic]).
| Study group | Role | What they receive |
|---|---|---|
| UHE-103A1 cream | Experimental | Topical cream applied twice daily for 2 weeks. Receives: Drug: UHE-103A1 cream |
| UHE-103A2 cream | Experimental | Topical cream applied twice daily for 2 weeks. Receives: Drug: UHE-103A2 cream |
| UHE-103B cream | Experimental | Topical cream applied twice daily for 2 weeks. Receives: Drug: UHE-103B cream |
| UHE-103A1B cream | Experimental | Topical cream applied twice daily for 2 weeks. Receives: Drug: UHE-103A1B cream |
| UHE-103A2B cream | Experimental | Topical cream applied twice daily for 2 weeks. Receives: Drug: UHE-103A2B cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 43
Secondary outcomes (2)
Effective treatment
Proportion of subjects with Effective Treatment (negative fungal test \& no to mild clinical disease-induced signs and symptoms) at EOS.
Measured: Day 43
Mycological Cure
Proportion of subjects with Mycological Cure (negative fungal test) at EOS.
Measured: Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start15 Mar 2019
- Primary completion21 Oct 2019
- Study completion5 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinea PedisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marietta Radona, MD, Principal investigator, Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03897257
- Sponsor's protocol ID
- 146-9252-201
- Status last verified
- Oct 2021
- First submitted
- 28 Mar 2019
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03897257
- Acronym / sponsor ID
- 146-9252-201
- Conditions
- Tinea Pedis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 21 Oct 2019 (actual)
- Study completion
- 5 May 2020 (actual)
- First posted
- 1 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- 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)
| Arm | Type | Receives |
|---|---|---|
| UHE-103A1 cream | Experimental | Drug: UHE-103A1 creamTopical cream applied twice daily for 2 weeks. |
| UHE-103A2 cream | Experimental | Drug: UHE-103A2 creamTopical cream applied twice daily for 2 weeks. |
| UHE-103B cream | Experimental | Drug: UHE-103B creamTopical cream applied twice daily for 2 weeks. |
| UHE-103A1B cream | Experimental | Drug: UHE-103A1B creamTopical cream applied twice daily for 2 weeks. |
| UHE-103A2B cream | Experimental | Drug: UHE-103A2B creamTopical cream applied twice daily for 2 weeks. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UHE-103A1 creamInvestigational mono-therapy cream (containing drug A [low dose]). Drug A is an antifungal agent. | Drug | UHE-103A1 cream |
| UHE-103A2 creamInvestigational mono-therapy cream (containing drug A [low dose]). Drug A is an antifungal agent. | Drug | UHE-103A2 cream |
| UHE-103B creamComparator mono-therapy cream (containing drug B). Drug B is a keratolytic agent. | Drug | UHE-103B cream |
| UHE-103A1B creamInvestigational combination-therapy cream (containing drug A [low dose antifungal] + drug B [keratolytic]). | Drug | UHE-103A1B cream |
| UHE-103A2B creamInvestigational combination-therapy cream (containing drug A [high dose antifungal] + drug B [keratolytic]). | Drug | UHE-103A2B cream |
Primary outcome
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).
2 secondary outcomes
Effective treatment
Time frame: Day 43
Mycological Cure
Time frame: Day 43
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marietta Radona, MD principal investigator
Therapeutics, Inc.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UHE-103A1 cream, UHE-103A2 cream and UHE-103B cream in people with Tinea Pedis, run by Therapeutics, Inc. at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Cure at End of Study (time frame: Day 43). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2021.