Interdigital Tinea PedisPhase 1BNF-0909NCT01119742
Clinical Equivalence of Two Generic Butenafine Hydrochloride 1% Creams as Compared to Lotrimin Ultra Cream in Patients With Interdigital Tinea Pedis
A Phase 1 study testing Butenafine Hydrochloride 1% and Butenafine Hydrochloride 1% B in people with Interdigital Tinea Pedis, run by Sun Pharmaceutical Industries, Inc..
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 18 years and older
- Conditions the study is for
- Interdigital Tinea Pedis
- What is being tested?
- Butenafine Hydrochloride 1% and Butenafine Hydrochloride 1% B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 428 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Jul 2011
- 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
- Male or non-pregnant, non lactating females 18 years of age or older.
- Signed informed consent form, which meets all criteria of current FDA regulations and the requirements of the India regulatory authorities.
- If female and of child bearing potential, have a negative urine pregnancy test at the baseline visit,
- A total score of at least six (6) for the following eight (8) clinical signs and symptoms of interdigital tinea pedis: fissuring, erythema, maceration, vesiculation, desquamation/scaling, exudation, pruritus, burning/stinging. In addition the most infected area must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for either pruritus or desquamation/scaling
- A confirmed clinical diagnosis of interdigital tinea pedis.
- The presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic 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 mentagrophytes or Epidermophyton floccosum.
Who cannot join
- Use of any of the following within the indicated timeline:
- Oral or injectable steroids within four weeks of the study start.
- 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 OTC topical antifungal on the feet within two weeks prior to study entry.
- Use of any antihistamines within 72 hours of the study start.
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- 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 Investigators 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.
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multiple-Site Study to Evaluate the Clinical Equivalence of Two Generic Butenafine Hydrochloride 1% Creams to Lotrimin Ultra® Cream 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
- Interdigital Tinea Pedis
- Being tested
- Butenafine Hydrochloride 1%, Butenafine Hydrochloride 1% B, Vehicle A, Vehicle B
- Keywords
- Tinea Pedis, Interdigital
- 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 Hydrochloride 1%Drug
Twice daily application for 7 days
Butenafine Hydrochloride 1% BDrug
Twice daily application for 7 days
Butenafine Hydrochloride 1%Drug
Also called Lotrimin Ultra Cream
Twice daily application for 7 days
Vehicle ADrug
Twice daily application for 7 days
Vehicle BDrug
Twice daily application for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Butenafine Hydrochloride 1% A | Experimental | 1 Receives: Drug: Butenafine Hydrochloride 1% |
| Butenafine Hydrochloride 1% B | Experimental | 2 Receives: Drug: Butenafine Hydrochloride 1% B |
| Butenafine Hydrochloride 1% | Active comparator | 3 Receives: Drug: Butenafine Hydrochloride 1% |
| Vehicle A | Placebo comparator | 4 Receives: Drug: Vehicle A |
| Vehicle B | Placebo comparator | 5 Receives: Drug: Vehicle B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic Cure
Patients with clinical cure and mycologic cure are considered therapeutic cures.
Measured: 42 Days
Secondary outcomes (2)
Clinical Cure
Patient will be considered a "clincal cure" if the score for erythema is equal or less than 2 and the total score for all of the other seven signs and symptoms is less than 2.
Measured: 42 days
Mycologic Cure
Patient will be considered a "mycological cure" if the results of both the potassium hydroxide (KOH) and the fungal culture are negative.
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 posted10 May 2010 (estimated)
- Study startJul 2010
- Primary completionMar 2011
- Study completionJul 2011
Why it stopped: Insufficient number of baseline eligible patient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interdigital 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 428 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
- NCT01119742
- Sponsor's protocol ID
- BTNF-0909
- Acronym
- BNF-0909
- Status last verified
- May 2014
- First submitted
- 6 May 2010
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 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 Generic Butenafine Hydrochloride 1% Creams to Lotrimin Ultra® Cream in Patients With Interdigital Tinea Pedis
- ClinicalTrials.gov ID
- NCT01119742
- Acronym / sponsor ID
- BNF-0909 / BTNF-0909
- Conditions
- Interdigital Tinea Pedis
- Keywords
- Tinea Pedis, Interdigital
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient number of baseline eligible patient
- Enrolment
- 428 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 10 May 2010 (estimated)
- 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.
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
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Butenafine Hydrochloride 1% A | Experimental | Drug: Butenafine Hydrochloride 1%1 |
| Butenafine Hydrochloride 1% B | Experimental | Drug: Butenafine Hydrochloride 1% B2 |
| Butenafine Hydrochloride 1% | Active comparator | Drug: Butenafine Hydrochloride 1%3 |
| Vehicle A | Placebo comparator | Drug: Vehicle A4 |
| Vehicle B | Placebo comparator | Drug: Vehicle B5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or non-pregnant, non lactating females 18 years of age or older.
- Signed informed consent form, which meets all criteria of current FDA regulations and the requirements of the India regulatory authorities.
- If female and of child bearing potential, have a negative urine pregnancy test at the baseline visit,
- A total score of at least six (6) for the following eight (8) clinical signs and symptoms of interdigital tinea pedis: fissuring, erythema, maceration, vesiculation, desquamation/scaling, exudation, pruritus, burning/stinging. In addition the most infected area must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for either pruritus or desquamation/scaling
- A confirmed clinical diagnosis of interdigital tinea pedis.
Key exclusion criteria (9 listed)
- Use of any of the following within the indicated timeline:
- 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 Investigators 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.
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 Hydrochloride 1%Twice daily application for 7 days | Drug | Butenafine Hydrochloride 1% A |
| Butenafine Hydrochloride 1% BTwice daily application for 7 days | Drug | Butenafine Hydrochloride 1% B |
| Butenafine Hydrochloride 1%Also: Lotrimin Ultra CreamTwice daily application for 7 days | Drug | Butenafine Hydrochloride 1% |
| Vehicle ATwice daily application for 7 days | Drug | Vehicle A |
| Vehicle BTwice daily application for 7 days | Drug | Vehicle B |
Primary outcome
Therapeutic Cure
Time frame: 42 Days
Patients with clinical cure and mycologic cure are considered therapeutic cures.
2 secondary outcomes
Clinical Cure
Time frame: 42 days
Mycologic Cure
Time frame: 42 Days
Results and safety
The study was stopped early (reason given: Insufficient number of baseline eligible patient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2014.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Butenafine Hydrochloride 1% and Butenafine Hydrochloride 1% B in people with Interdigital Tinea Pedis, run by Sun Pharmaceutical Industries, Inc..
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 7 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: stopped early, as of the sponsor's last update on 6 May 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was stopped early (reason given: Insufficient number of baseline eligible patient). Results are not available in the source record.
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 (time frame: 42 Days). 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 6 May 2014.