Tinea PedisPhase 1NCT00835510
Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis
A Phase 1 study testing Butenafine cream 1% manufactured by Taro and Lotrimin Ultra (butenafine) 1% in people with Tinea Pedis, run by Sun Pharmaceutical Industries, Inc. at 17 sites in 2 countries.
Trial summary
To demonstrate comparable safety and efficacy of Taro Pharmaceuticals Inc. butenafine hydrochloride cream 1% (test product) and Lotrimin Ultra® cream (reference listed drug) in the treatment of interdigital tinea pedis, and to show the superiority of the active treatments over that of the placebo (vehicle). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Tinea Pedis
- What is being tested?
- Butenafine cream 1% manufactured by Taro and Lotrimin Ultra (butenafine) 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 548 participants
- Where
- 17 sitesin 2 countries
- Study dates
- Jun 2008to Dec 2008
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Microbiologically confirmed clinical diagnosis of interdigital tinea pedis
- If female and of child bearing potential, prepare to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom, intra-uterine device (IUD), oral, transdermal, injected or implanted hormonal contraceptives).
- A confirmed clinical diagnosis of interdigital tinea pedis. Lesions are to be predominately interdigital but may extend to other areas of the foot (the non-interdigital lesions must not be hyperkeratotic).
- The presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic potassium hydroxide (KOH) wet mount examination (potassium hydroxide mount preparation).
- Identification of an appropriate dermatophyte by culture sent to the central laboratory. The appropriate dermatophytes are Trichophyton rubrum, Trichophyton mentagrophyte or Epidermophyton floccosum.
Who cannot join
- Use of any of the following within the indicated timeline:
- Oral or injectable steroids
- Any oral anti-fungals within 4 weeks of the study start
- Use of topical corticosteroids or any other topical antipruritics on the feet within 72 hours of the study start.
- Any prescription or over-the-counter (OTC) topical antifungals on the feet within two weeks prior to study entry
- Use of any antihistamines within 72 hours of the study start.
Show all 9Show fewer
- Any known hypersensitivity to butenafine or other antifungal agents.
- Evidence of any concurrent dermatophytic infection of toe nails (onychomycosis) or other dermatological condition of the foot that may interfere with the Investigator's evaluation of tinea pedis.
- Patients with recurrent tinea pedis (more than 3 infections in the past 12 months) who have been unresponsive to previous antifungal therapy.
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
United States16 sites
Investigator Site
Bristol, Tennessee
Investigator Site
Burbank, California
Investigator Site
Clinton Township, Michigan
Investigator Site
College Station, Texas
Investigator Site
Hickory, North Carolina
Investigator Site
Houston, Texas
Investigator Site
Martinez, Georgia
Investigator Site
Miami, Florida
Investigator Site
Nashville, Tennessee
Investigator Site
Raleigh, North Carolina
Investigator Site
Salisbury, North Carolina
Investigator Site
San Antonio, Texas
Investigator Site
San Diego, California
Investigator Site
Simpsonville, South Carolina
Investigator Site
Stockbridge, Georgia
Investigator Site
Sylvania, Ohio
Belize1 site
Investigator Site
Belize City
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multiple-Site Study to Evaluate the Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis
To demonstrate comparable safety and efficacy of Taro Pharmaceuticals Inc. butenafine hydrochloride cream 1% (test product) and Lotrimin Ultra® cream (reference listed drug) in the treatment of interdigital tinea pedis, and to show the superiority of the active treatments over that of the placebo (vehicle).
- Conditions
- Tinea Pedis
- Being tested
- Butenafine cream 1% manufactured by Taro, Lotrimin Ultra (butenafine) 1%, Butenafine Vehicle manufactured by Taro
- Keywords
- Tinea pedis
- Medical subject headings
- Tinea Pedis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Butenafine cream 1% manufactured by TaroDrug
Treatment applied to affected area twice daily for 7 days
Lotrimin Ultra (butenafine) 1%Drug
Treatment applied to affected area twice daily for 7 days
Butenafine Vehicle manufactured by TaroDrug
Treatment applied to affected area twice daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Butenafine cream 1% (Taro) | Experimental | Butenafine cream manufactured by Taro applied for 7 days Receives: Drug: Butenafine cream 1% manufactured by Taro |
| Lotrimin Ultra (butenafine) 1% | Active comparator | Lotrimin Ultra (butenafine) applied for 7 days Receives: Drug: Lotrimin Ultra (butenafine) 1% |
| Vehicle | Placebo comparator | Butenafine vehicle applied for 7 days Receives: Drug: Butenafine Vehicle manufactured by Taro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic Cure - Superiority Analysis
Therapeutic Cure requires both Clinical Cure and Mycological Cure.
Clinical Cure was based on the following signs and symptoms: fissuring, erythema, maceration, vesiculation, scaling, exudation, pruritus, burning. Each clinical symptom was evaluated using a 0-3 point rating scale: none=0, mild=1, moderate=2 or severe=3. If the score for erythema was ≤ 2 and the sum for all of the other 7 signs and symptoms was <2 then the patient was considered a Clinical Cure.
Mycological Cure: The potassium hydroxide (KOH) and the fungal culture were both negative.
Measured: 42 days
Therapeutic Cure Non-Inferiority Comparison of Butenafine Cream and Lotrimin Ultra
Patient was cured both by symptoms (Clinical Cure) and by the results of fungal testing (Mycological Cure).
Measured: 42 days
Secondary outcomes (4)
Therapeutic Cure
Subject with clinical and mycological cure at day 7
Measured: 7 days
Mycologic Cure
Negative KOH and fungal culture at day 42
Measured: 42 days
Clinical Cure
The following 8 signs and symptoms are rated at each visit:
Erythema Fissuring Maceration Vesiculation Desquamation/scaling Exudation Pruritus Stinging/Burning
Each symptom is evaluated using the following scale:
0 = None- Complete absence of any sign or symptom
- = Mild - obvious but minimal involvement
- = Moderate - something that is easily noted
- = Severe - quite marked
Clinical cure is defined as a score of 2 (moderate) or less for erythema and a total score for seven other signs and symptoms less than 2.
Measured: 42 days
Safety and Adverse Event Profile
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startJun 2008
- Primary completionOct 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 548 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00835510
- Sponsor's protocol ID
- BTNF-0708
- Status last verified
- Jan 2014
- First submitted
- 30 Jan 2009
- Last updated
- 4 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multiple-Site Study to Evaluate the Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis
- ClinicalTrials.gov ID
- NCT00835510
- Acronym / sponsor ID
- BTNF-0708
- Conditions
- Tinea Pedis
- Keywords
- Tinea pedis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 548 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 3 Feb 2009 (estimated)
- Results
- Posted 6 Oct 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate comparable safety and efficacy of Taro Pharmaceuticals Inc. butenafine hydrochloride cream 1% (test product) and Lotrimin Ultra® cream (reference listed drug) in the treatment of interdigital tinea pedis, and to show the superiority of the active treatments over that of the placebo (vehicle).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Butenafine cream 1% (Taro) | Experimental | Drug: Butenafine cream 1% manufactured by TaroButenafine cream manufactured by Taro applied for 7 days |
| Lotrimin Ultra (butenafine) 1% | Active comparator | Drug: Lotrimin Ultra (butenafine) 1%Lotrimin Ultra (butenafine) applied for 7 days |
| Vehicle | Placebo comparator | Drug: Butenafine Vehicle manufactured by TaroButenafine vehicle applied for 7 days |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Microbiologically confirmed clinical diagnosis of interdigital tinea pedis
- If female and of child bearing potential, prepare to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom, intra-uterine device (IUD), oral, transdermal, injected or implanted hormonal contraceptives).
- A confirmed clinical diagnosis of interdigital tinea pedis. Lesions are to be predominately interdigital but may extend to other areas of the foot (the non-interdigital lesions must not be hyperkeratotic).
- The presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic potassium hydroxide (KOH) wet mount examination (potassium hydroxide mount preparation).
- Identification of an appropriate dermatophyte by culture sent to the central laboratory. The appropriate dermatophytes are Trichophyton rubrum, Trichophyton mentagrophyte or Epidermophyton floccosum.
Key exclusion criteria (9 listed)
- Use of any of the following within the indicated timeline:
- Oral or injectable steroids
- Any oral anti-fungals within 4 weeks of the study start
- Use of topical corticosteroids or any other topical antipruritics on the feet within 72 hours of the study start.
- Any prescription or over-the-counter (OTC) topical antifungals on the feet within two weeks prior to study entry
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 |
|---|---|---|
| Butenafine cream 1% manufactured by TaroTreatment applied to affected area twice daily for 7 days | Drug | Butenafine cream 1% (Taro) |
| Lotrimin Ultra (butenafine) 1%Treatment applied to affected area twice daily for 7 days | Drug | Lotrimin Ultra (butenafine) 1% |
| Butenafine Vehicle manufactured by TaroTreatment applied to affected area twice daily for 7 days | Drug | Vehicle |
Primary outcome
Therapeutic Cure - Superiority Analysis
Time frame: 42 days
Therapeutic Cure requires both Clinical Cure and Mycological Cure. Clinical Cure was based on the following signs and symptoms: fissuring, erythema, maceration, vesiculation, scaling, exudation, pruritus, burning. Each clinical symptom was evaluated using a 0-3 point rating scale: none=0, mild=1, moderate=2 or severe=3. If the score for erythema was ≤ 2 and the sum for all of the other 7 signs and symptoms was <2 then the patient was considered a Clinical Cure. Mycological Cure: The potassium hydroxide (KOH) and the fungal culture were both negative.
Therapeutic Cure Non-Inferiority Comparison of Butenafine Cream and Lotrimin Ultra
Time frame: 42 days
Patient was cured both by symptoms (Clinical Cure) and by the results of fungal testing (Mycological Cure).
4 secondary outcomes
Therapeutic Cure
Time frame: 7 days
Mycologic Cure
Time frame: 42 days
Clinical Cure
Time frame: 42 days
Safety and Adverse Event Profile
Time frame: 42 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Butenafine cream 1% manufactured by Taro and Lotrimin Ultra (butenafine) 1% in people with Tinea Pedis, run by Sun Pharmaceutical Industries, Inc. at 17 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 9 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 4 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Belize. 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 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?
Yes. Results are posted in the registry (first posted 6 Oct 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Therapeutic Cure - Superiority Analysis (time frame: 42 days). The study lists 2 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 4 Feb 2014.