Tinea PedisPhase 2NCT03999437
SINGLE-APPLICATION TERBINAFINE HYDROCHLORIDE (1%) TOPICAL LIQUID SOLUTION VERSUS A SINGLE-APPLICATION BUTENAFINE HYDROCHLORIDE (1%) TOPICAL LIQUID SOLUTION FOR THE TREATMENT OF TINEA PEDIS
A Phase 2 study testing TERBINAFINE HYDROCHLORIDE (1%) and BUTENAFINE HYDROCHLORIDE (1%) in people with Tinea Pedis, run by United Laboratories at 1 site in Philippines.
Trial summary
Tinea pedis or athlete's foot is the most common fungal infection worldwide, caused by infection of the feet with dermatophytes such as Trichophyton rubrum, Trichophyton interdigitale (formerly Trichophyton mentagrophytes), and Epidermophyton floccosum. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tinea Pedis
- What is being tested?
- TERBINAFINE HYDROCHLORIDE (1%) and BUTENAFINE HYDROCHLORIDE (1%)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 sitePhilippines
- Study dates
- 2 Jan 2019to 3 Jan 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or nonpregnant females aged 18-60 years old.
- Clinical diagnosis of tinea pedis (total sign/symptom score >2), lesions between the toes, with possible extension to the lateral surfaces and soles of the feet confirmed by a positive microscopy prior to dosing.
- Willing to sign the informed consent.
Who cannot join
- Females who are pregnant (confirmed by a pregnancy test), suspect themselves to be pregnant (even if pregnancy test is negative), breast-feeding, or planning a pregnancy.
- Signs of systemic or other superficial fungal disease (e.g.onychomycosis), clinically relevant abnormal findings upon physical examination of the foot or previous treatment with a disallowed medication (such as corticosteroids).
- Presence of non-healing wounds and/or bacterial infection on the feet.
- Secondary bacterial infection due to tinea pedis
- Presence of pigmentation, extensive scarring, or pigmented lesions in the treatment areas, which could interfere with the rating of efficacy parameters.
- History of hypersensitivity to any component of the test products.
- Current imuunosuppression. Specifically, these include patients with co-morbidities such as diabetes, HIV, chronic diseases requiring maintenance medications, acute febrile/infectious illnesses (i.e. Dengue, pneumonia, etc)
- Use within 3 months prior to baseline of: 1.) chemotherapy, or 2.) radiation therapy
Trial locations and contacts
1 site in 1 country.
Philippines1 site, 1 recruiting
- Recruiting
Clinical Trial Management and Testing Associates, Inc.
City of Muntinlupa
Gertrude Chan, M.D., (632) 659-3238, clintrialtest@gmail.com
About this study
Official title: EFFICACY AND SAFETY OF A SINGLE-APPLICATION TREATMENT USING TERBINAFINE HYDROCHLORIDE (1%) TOPICAL LIQUID SOLUTION VERSUS A SINGLE-APPLICATION TREATMENT USING BUTENAFINE HYDROCHLORIDE (1%) TOPICAL LIQUID SOLUTION FOR THE TREATMENT OF TINEA PEDIS: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL
Tinea pedis or athlete's foot is the most common fungal infection worldwide, caused by infection of the feet with dermatophytes such as Trichophyton rubrum, Trichophyton interdigitale (formerly Trichophyton mentagrophytes), and Epidermophyton floccosum. Diagnosis of tinea pedia involves clinical symptoms as well as microscopic examination. Topical therapies are usually applied once or twice daily for as long as 4 weeks, posing a challenge to compliance. The current study aims to test a formulation of the single-dose 1% terbinafine hydrochloride, as well as a single-dose 1% butenafine hydrochloride, versus a vehicle control in adult Filipino patients with athlete's foot. This study will benefit the Filipino community by helping us determine which anti-fungal cream is most effective for athlete's foot.
- Conditions
- Tinea Pedis
- Being tested
- TERBINAFINE HYDROCHLORIDE (1%), BUTENAFINE HYDROCHLORIDE (1%), Vehicle Control
- Medical subject headings
- Tinea Pedis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TERBINAFINE HYDROCHLORIDE (1%)Drug
Topical liquid solution
BUTENAFINE HYDROCHLORIDE (1%)Drug
Topical liquid solution
Vehicle ControlDrug
Topical liquid solution
| Study group | Role | What they receive |
|---|---|---|
| Treatment # 1 | Experimental | Not described Receives: Drug: TERBINAFINE HYDROCHLORIDE (1%) |
| Treatment # 2 | Experimental | Not described Receives: Drug: BUTENAFINE HYDROCHLORIDE (1%) |
| Placebo Control | Placebo comparator | Not described Receives: Drug: Vehicle Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with effective treatment at week 6
Defined as negative microscopy and improvement in signs and symptoms: mild or no erythema, desquamation or pruritis (<=1), no vesiculation, and a total sign/symptom score of <=2.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start2 Jan 2019
- Primary completion13 Dec 2019 (estimated)
- Study completion3 Jan 2020 (estimated)
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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999437
- Sponsor's protocol ID
- RD2018-02
- Status last verified
- Jun 2019
- First submitted
- 24 Jun 2019
- Last updated
- 26 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFICACY AND SAFETY OF A SINGLE-APPLICATION TREATMENT USING TERBINAFINE HYDROCHLORIDE (1%) TOPICAL LIQUID SOLUTION VERSUS A SINGLE-APPLICATION TREATMENT USING BUTENAFINE HYDROCHLORIDE (1%) TOPICAL LIQUID SOLUTION FOR THE TREATMENT OF TINEA PEDIS: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT03999437
- Acronym / sponsor ID
- RD2018-02
- Conditions
- Tinea Pedis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- United LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 13 Dec 2019 (estimated)
- Study completion
- 3 Jan 2020 (estimated)
- First posted
- 26 Jun 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.
Tinea pedis or athlete's foot is the most common fungal infection worldwide, caused by infection of the feet with dermatophytes such as Trichophyton rubrum, Trichophyton interdigitale (formerly Trichophyton mentagrophytes), and Epidermophyton floccosum. Diagnosis of tinea pedia involves clinical symptoms as well as microscopic examination. Topical therapies are usually applied once or twice daily for as long as 4 weeks, posing a challenge to compliance. The current study aims to test a formulation of the single-dose 1% terbinafine hydrochloride, as well as a single-dose 1% butenafine hydrochloride, versus a vehicle control in adult Filipino patients with athlete's foot. This study will benefit the Filipino community by helping us determine which anti-fungal cream is most effective for athlete's foot.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment # 1 | Experimental | Drug: TERBINAFINE HYDROCHLORIDE (1%) |
| Treatment # 2 | Experimental | Drug: BUTENAFINE HYDROCHLORIDE (1%) |
| Placebo Control | Placebo comparator | Drug: Vehicle Control |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or nonpregnant females aged 18-60 years old.
- Clinical diagnosis of tinea pedis (total sign/symptom score >2), lesions between the toes, with possible extension to the lateral surfaces and soles of the feet confirmed by a positive microscopy prior to dosing.
- Willing to sign the informed consent.
Key exclusion criteria (8 listed)
- Females who are pregnant (confirmed by a pregnancy test), suspect themselves to be pregnant (even if pregnancy test is negative), breast-feeding, or planning a pregnancy.
- Signs of systemic or other superficial fungal disease (e.g.onychomycosis), clinically relevant abnormal findings upon physical examination of the foot or previous treatment with a disallowed medication (such as corticosteroids).
- Presence of non-healing wounds and/or bacterial infection on the feet.
- Secondary bacterial infection due to tinea pedis
- Presence of pigmentation, extensive scarring, or pigmented lesions in the treatment areas, which could interfere with the rating of efficacy parameters.
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 |
|---|---|---|
| TERBINAFINE HYDROCHLORIDE (1%)Topical liquid solution | Drug | Treatment # 1 |
| BUTENAFINE HYDROCHLORIDE (1%)Topical liquid solution | Drug | Treatment # 2 |
| Vehicle ControlTopical liquid solution | Drug | Placebo Control |
Primary outcome
Proportion of participants with effective treatment at week 6
Time frame: 6 weeks
Defined as negative microscopy and improvement in signs and symptoms: mild or no erythema, desquamation or pruritis (<=1), no vesiculation, and a total sign/symptom score of <=2.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TERBINAFINE HYDROCHLORIDE (1%) and BUTENAFINE HYDROCHLORIDE (1%) in people with Tinea Pedis, run by United Laboratories at 1 site in Philippines.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juliene Co, PhD ((632)8580001 ext. 8553, julieneco@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with effective treatment at week 6 (time frame: 6 weeks). 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 26 Jun 2019.