Tinea CrurisPhase 1NCT05363449
Safety, Tolerability, and Pharmacokinetics of UHE-103 Cream in Subjects With Tinea Cruris and/or Tinea Pedis
A Phase 1 study testing UHE-103 Cream and Naftin (naftifine hydrochloride) Cream in people with Tinea Cruris and Tinea Pedis, run by Therapeutics, Inc. at 5 sites in United States.
Trial summary
This Phase 1 study has been designed to determine the safety, tolerability and pharmacokinetics (PK) of UHE 103 Cream compared to Naftin Cream, 2% under maximal use conditions for 2 weeks treatment in subjects with tinea cruris and/or tinea pedis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinea Cruris, Tinea Pedis
- What is being tested?
- UHE-103 Cream and Naftin (naftifine hydrochloride) Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 5 sitesUnited States
- Study dates
- 17 Feb 2022to 14 Nov 2023
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is a male or non-pregnant female 18 years of age or older.
- Subject has provided written informed consent.
- Subject has a clinical diagnosis of moccasin-type tinea pedis with at least moderate scaling on at least 1 foot at Visit 1/Screening;
- Subject has a clinical diagnosis of interdigital tinea pedis with at least moderate scaling on at least 1 foot (without moccasin-type tinea pedis) and tinea cruris at Visit 1/Screening.
- Subject is willing and able to apply the test article(s) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
Who cannot join
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject has any skin pathology or condition that could interfere with the evaluation of the test article or requires use of interfering topical, systemic, or surgical therapy.
- Subject has any clinically significant medical abnormality or history of chronic disease (cardiovascular, gastrointestinal, neurological, hematopoietic, immunosuppression [HIV], hepatic [Hepatitis B or C], psychological, renal systems, or respiratory), including conditions (e.g., gastrointestinal surgery) that may interfere with the absorption, metabolism, or excretion of investigational product.
- Subject has used any of the following topical products on the feet or groin within 4 weeks of Visit 2/Enrollment: antifungals, antibacterials, or corticosteroid therapy.
- Subject has applied any topical naftifine products to any part of their body within 4 weeks of Visit 2/Enrollment.
- Subject has used topical keratolytics (e.g., urea, ammonium lactate, salicylic acid) on the feet or groin within 1 week of Visit 2/Enrollment.
Show all 12Show fewer
- Subject has used any other topical products on the feet or groin within 24 hours of Visit 2/Enrollment including, but not limited to non-medicated moisturizers, antipruritics, analgesics, anesthetics, etc.
- Subject has received systemic antifungal therapy within 8 weeks or 5 half lives of the antifungal (whichever is longer) of Visit 2/Enrollment.
- Subject is currently enrolled in an investigational drug, biologic, or device study.
- Subject has previously been enrolled in a study for UHE-103.
- Subject has used an investigational drug, investigational biologic, or investigational device treatment within 30 days prior to Visit 2/Enrollment.
- Subject has a history of sensitivity to any of the ingredients in the test articles.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Site #2
Austin, Texas, 78759
Site #3
College Station, Texas, 77845
Site #4
Houston, Texas, 77055
Site #1
San Diego, California, 92123
Site #5
Thousand Oaks, California, 91320
About this study
Official title: An Open Label, Parallel Group Comparison Study To Evaluate the Safety Tolerability, and Pharmacokinetics of UHE-103 Cream Versus Naftin Cream in Subjects With Tinea Cruris and/or Tinea Pedis Under Maximal Use Conditions
This Phase 1 study has been designed to determine the safety, tolerability and pharmacokinetics (PK) of UHE 103 Cream compared to Naftin Cream, 2% under maximal use conditions for 2 weeks treatment in subjects with tinea cruris and/or tinea pedis
- Conditions
- Tinea Cruris, Tinea Pedis
- Being tested
- UHE-103 Cream, Naftin (naftifine hydrochloride) Cream
- Medical subject headings
- Tinea Cruris, Tinea Pedis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UHE-103 CreamDrug
UHE-103 is an investigational combinational therapy containing keratolytic and antifungal
Naftin (naftifine hydrochloride) CreamDrug
Naftin (naftifine hydrochloride) Cream, 2%. Topical cream containing active drug
| Study group | Role | What they receive |
|---|---|---|
| UHE-103 Cream | Experimental | Subjects will apply at least a total of 4 grams* of the test article, covering both feet twice daily for 2 weeks Receives: Drug: UHE-103 Cream |
| Naftin (naftifine hydrochloride) Cream, 2% | Active comparator | Subjects will apply at least a total of 5 grams* of the test article, covering the interdigital areas of both feet and to the groin once daily for 2 weeks Receives: Drug: Naftin (naftifine hydrochloride) Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
Percentage of subjects with any local and systemic AEs defined as "possibly" or "probably" or "definitely" related by the investigator.
Measured: Baseline up to Day 16
Local Skin Reactions (LSRs)
Percentage of subjects with presence of any of the following LSRs at the end of the study: burning/stinging, edema, and oozing/vesiculation/crusting.
Measured: Day 16
AUC (0-12 hours)
Defined as the area concentration-time curve (AUC) of the active antifungal drug from time 0 to 12 hours.
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start17 Feb 2022
- Primary completion14 Nov 2023
- Study completion14 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinea CrurisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tony Andrasfay, Study director, Therapeutics Inc. (CRO)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363449
- Sponsor's protocol ID
- 146-9252-102
- Status last verified
- Apr 2024
- First submitted
- 10 Mar 2022
- Last updated
- 10 Apr 2024
- 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 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Parallel Group Comparison Study To Evaluate the Safety Tolerability, and Pharmacokinetics of UHE-103 Cream Versus Naftin Cream in Subjects With Tinea Cruris and/or Tinea Pedis Under Maximal Use Conditions
- ClinicalTrials.gov ID
- NCT05363449
- Acronym / sponsor ID
- 146-9252-102
- Conditions
- Tinea Cruris, Tinea Pedis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 14 Nov 2023 (actual)
- Study completion
- 14 Nov 2023 (actual)
- First posted
- 5 May 2022 (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.
This Phase 1 study has been designed to determine the safety, tolerability and pharmacokinetics (PK) of UHE 103 Cream compared to Naftin Cream, 2% under maximal use conditions for 2 weeks treatment in subjects with tinea cruris and/or tinea pedis
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UHE-103 Cream | Experimental | Drug: UHE-103 CreamSubjects will apply at least a total of 4 grams* of the test article, covering both feet twice daily for 2 weeks |
| Naftin (naftifine hydrochloride) Cream, 2% | Active comparator | Drug: Naftin (naftifine hydrochloride) CreamSubjects will apply at least a total of 5 grams* of the test article, covering the interdigital areas of both feet and to the groin once daily for 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is a male or non-pregnant female 18 years of age or older.
- Subject has provided written informed consent.
- Subject has a clinical diagnosis of moccasin-type tinea pedis with at least moderate scaling on at least 1 foot at Visit 1/Screening;
- Subject has a clinical diagnosis of interdigital tinea pedis with at least moderate scaling on at least 1 foot (without moccasin-type tinea pedis) and tinea cruris at Visit 1/Screening.
- Subject is willing and able to apply the test article(s) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
Key exclusion criteria (12 listed)
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject has any skin pathology or condition that could interfere with the evaluation of the test article or requires use of interfering topical, systemic, or surgical therapy.
- Subject has any clinically significant medical abnormality or history of chronic disease (cardiovascular, gastrointestinal, neurological, hematopoietic, immunosuppression [HIV], hepatic [Hepatitis B or C], psychological, renal systems, or respiratory), including conditions (e.g., gastrointestinal surgery) that may interfere with the absorption, metabolism, or excretion of investigational product.
- Subject has used any of the following topical products on the feet or groin within 4 weeks of Visit 2/Enrollment: antifungals, antibacterials, or corticosteroid therapy.
- Subject has applied any topical naftifine products to any part of their body within 4 weeks of Visit 2/Enrollment.
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-103 CreamUHE-103 is an investigational combinational therapy containing keratolytic and antifungal | Drug | UHE-103 Cream |
| Naftin (naftifine hydrochloride) CreamNaftin (naftifine hydrochloride) Cream, 2%. Topical cream containing active drug | Drug | Naftin (naftifine hydrochloride) Cream, 2% |
Primary outcome
Adverse Events (AEs)
Time frame: Baseline up to Day 16
Percentage of subjects with any local and systemic AEs defined as "possibly" or "probably" or "definitely" related by the investigator.
Local Skin Reactions (LSRs)
Time frame: Day 16
Percentage of subjects with presence of any of the following LSRs at the end of the study: burning/stinging, edema, and oozing/vesiculation/crusting.
AUC (0-12 hours)
Time frame: Day 15
Defined as the area concentration-time curve (AUC) of the active antifungal drug from time 0 to 12 hours.
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 10 Apr 2024.
- 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.
Tony Andrasfay study director
Therapeutics Inc. (CRO)
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UHE-103 Cream and Naftin (naftifine hydrochloride) Cream in people with Tinea Cruris and Tinea Pedis, run by Therapeutics, Inc. at 5 sites in United States.
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 12 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 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Adverse Events (AEs) (time frame: Baseline up to Day 16). The study lists 3 primary outcomes in all. 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 10 Apr 2024.