Tinea PedisPhase 1NCT01580878
Evaluate the Safety & Bioequivalence of a Generic Butenafine Cream & Lotrimin Ultra® & Compare Both to a Vehicle Control in Treatment of Interdigital Tinea Pedis
A Phase 1 study testing Butenafine Hydrochloride Cream, 1% and Lotrimin Ultra® in people with Tinea Pedis, run by Sun Pharmaceutical Industries, Inc..
Trial summary
The primary objective of this study is to determine the comparability of the safety and efficacy of a generic Butenafine Hydrochloride Cream, 1% (test product) and Lotrimin Ultra® (the reference listed drug) in subjects with interdigital tinea pedis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinea Pedis
- What is being tested?
- Butenafine Hydrochloride Cream, 1% and Lotrimin Ultra®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 707 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Dec 2012
- 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
- Willing \& able to provide \& understand written informed consent
- Healthy male or non-pregnant, non-lactating female at least 18 years of age and older
- Clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or that is predominantly interdigital but may extend to other areas
- Tinea pedis provisionally confirmed at baseline by positive potassium hydroxide (KOH)wet mount preparation showing segmented fungal hyphae
- Has sum of the clinical signs and symptoms scores of the target lesion of at least 4, including a minimum score of 2 for erythema \& a minimum score of 2 for scaling or pruritus
- Currently in general good health with no clinically significant disease
- Willing and able to understand and comply with study requirements
- Women of childbearing potential must have a negative urine pregnancy test and be willing to use an acceptable form of birth control during study
Who cannot join
- Females who are pregnant, breastfeeding, planning a pregnancy, or do not agree to use an acceptable form of birth control during the study
- Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface
- Presence of any other infection of the foot or other disease that might confound treatment evaluation
- History of dermatophyte infections unresponsive to antifungal drugs
- Known hypersensitivity to Butenafine Hydrochloride or any component of the study medications
- Use of antipruritics, topical systemic corticosteroid, antibiotic or antifungal therapy, oral terbinafine or itraconazole, or immunosuppressive medication or radiation therapy more recently than indicated washout period
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- Current oral, vaginal, or mucocutaneous candidiasis
- Current bacterial skin infection, secondary cellulitis, lymphangitis, or pyoderma
- Presence of current conditions that require systemic antimicrobial or antifungal therapy
- Uncontrolled diabetes mellitus, peripheral vascular disease, chronic venous stasis, or other significant condition
- Current severe onychomycosis
- Any clinically significant condition or situation, other than condition being studied, that would interfere with the study evaluations or participation
- Use of any investigational drugs or device within 30 days of signing Informed Consent Form (ICF)
- Current participation in any other clinical study
- Consumes excessive amounts of alcohol, abuses drugs, or has any condition that would compromise compliance
- Previous participation in this study
- Subjects with past history of tinea pedis with lack of response to antifungal therapy
- Subjects who in Investigator's opinion would be non-compliant
- Employees or direct relatives of an employee of the study center or Investigator
About this study
Official title: A Double-Blind, Randomized, Parallel-Group, Vehicle-Controlled, Multicenter Study to Evaluate the Safety and Bioequivalence of a Generic Butenafine Hydrochloride Cream, 1% and Reference Listed Lotrimin Ultra® (Butenafine Hydrochloride Cream, 1%) and Compare Both Active Treatments to a Vehicle Control in the Treatment of Interdigital Tinea Pedis.
The primary objective of this study is to determine the comparability of the safety and efficacy of a generic Butenafine Hydrochloride Cream, 1% (test product) and Lotrimin Ultra® (the reference listed drug) in subjects with interdigital tinea pedis. It will also be determined whether the efficacy of each of the two active treatments is superior to that of the vehicle cream (placebo).
- Conditions
- Tinea Pedis
- Being tested
- Butenafine Hydrochloride Cream, 1%, Lotrimin Ultra®, Butenafine Vehicle
- Keywords
- Butenafine Hydrochloride Cream, 1%, Lotrimin Ultra® Cream, 1%, Interdigital Tinea Pedis, Safety and Bioequivalence
- 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 Cream, 1%Drug
Butenafine Hydrochloride Cream, 1% applied twice daily for 7 consecutive days
Lotrimin Ultra®Drug
Lotrimin Ultra® (Butenafine Hydrochloride Cream, 1%) applied twice daily for 7 consecutive days.
Butenafine VehicleDrug
Butenafine Vehicle applied twice daily for 7 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Butenafine Hydrochloride Cream, 1% | Experimental | Butenafine Hydrochloride Cream, 1% (Taro Pharmaceuticals, Inc.) Receives: Drug: Butenafine Hydrochloride Cream, 1% |
| Lotrimin Ultra® | Active comparator | Lotrimin Ultra® (Butenafine Hydrochloride Cream, 1%) (Schering Plough HealthCare Products Inc.) Receives: Drug: Lotrimin Ultra® |
| Butenafine Vehicle | Placebo comparator | Butenafine Cream vehicle (Taro Pharmaceuticals Inc.) Receives: Drug: Butenafine Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic Cure
Subjects with both clinical cure and mycologic cure are considered therapeutic cures.
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 posted19 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionAug 2012
- Study completionDec 2012
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 707 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Symbio CRO, Study chair, http://symbioresearch.com/
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01580878
- Sponsor's protocol ID
- BTNF 1104
- Status last verified
- May 2017
- First submitted
- 17 Apr 2012
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Parallel-Group, Vehicle-Controlled, Multicenter Study to Evaluate the Safety and Bioequivalence of a Generic Butenafine Hydrochloride Cream, 1% and Reference Listed Lotrimin Ultra® (Butenafine Hydrochloride Cream, 1%) and Compare Both Active Treatments to a Vehicle Control in the Treatment of Interdigital Tinea Pedis.
- ClinicalTrials.gov ID
- NCT01580878
- Acronym / sponsor ID
- BTNF 1104
- Conditions
- Tinea Pedis
- Keywords
- Butenafine Hydrochloride Cream, 1%, Lotrimin Ultra® Cream, 1%, Interdigital Tinea Pedis, Safety and Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 707 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 19 Apr 2012 (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.
The primary objective of this study is to determine the comparability of the safety and efficacy of a generic Butenafine Hydrochloride Cream, 1% (test product) and Lotrimin Ultra® (the reference listed drug) in subjects with interdigital tinea pedis. It will also be determined whether the efficacy of each of the two active treatments is superior to that of the vehicle cream (placebo).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Butenafine Hydrochloride Cream, 1% | Experimental | Drug: Butenafine Hydrochloride Cream, 1%Butenafine Hydrochloride Cream, 1% (Taro Pharmaceuticals, Inc.) |
| Lotrimin Ultra® | Active comparator | Drug: Lotrimin Ultra®Lotrimin Ultra® (Butenafine Hydrochloride Cream, 1%) (Schering Plough HealthCare Products Inc.) |
| Butenafine Vehicle | Placebo comparator | Drug: Butenafine VehicleButenafine Cream vehicle (Taro Pharmaceuticals Inc.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Willing \& able to provide \& understand written informed consent
- Healthy male or non-pregnant, non-lactating female at least 18 years of age and older
- Clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or that is predominantly interdigital but may extend to other areas
- Tinea pedis provisionally confirmed at baseline by positive potassium hydroxide (KOH)wet mount preparation showing segmented fungal hyphae
- Has sum of the clinical signs and symptoms scores of the target lesion of at least 4, including a minimum score of 2 for erythema \& a minimum score of 2 for scaling or pruritus
Key exclusion criteria (19 listed)
- Females who are pregnant, breastfeeding, planning a pregnancy, or do not agree to use an acceptable form of birth control during the study
- Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface
- Presence of any other infection of the foot or other disease that might confound treatment evaluation
- History of dermatophyte infections unresponsive to antifungal drugs
- Known hypersensitivity to Butenafine Hydrochloride or any component of the study medications
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 Cream, 1%Butenafine Hydrochloride Cream, 1% applied twice daily for 7 consecutive days | Drug | Butenafine Hydrochloride Cream, 1% |
| Lotrimin Ultra®Lotrimin Ultra® (Butenafine Hydrochloride Cream, 1%) applied twice daily for 7 consecutive days. | Drug | Lotrimin Ultra® |
| Butenafine VehicleButenafine Vehicle applied twice daily for 7 consecutive days. | Drug | Butenafine Vehicle |
Primary outcome
Therapeutic Cure
Time frame: 42 days
Subjects with both clinical cure and mycologic cure are considered therapeutic cures.
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 5 May 2017.
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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.
Symbio CRO study chair
http://symbioresearch.com/
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Butenafine Hydrochloride Cream, 1% and Lotrimin Ultra® in people with 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 8 inclusion and 19 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 5 May 2017. 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 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?
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 5 May 2017.