Tinea PedisPhase 1NCT01580891
Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis
A Phase 1 study testing Naftifine HCl Cream 1% and Naftin® (Naftifine HCl) Cream 1% in people with Tinea Pedis, run by Sun Pharmaceutical Industries, Inc..
Trial summary
The objective of this study is to evaluate the efficacy and safety of the test formulation of Naftifine HCl Cream 1% (Taro Pharmaceuticals Inc.) as compared to the already marketed formulation Naftin® (Naftifine HCl) 1% Cream (Merz Pharmaceuticals) and placebo in patients with tinea pedis and to show the superiority… 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?
- Naftifine HCl Cream 1% and Naftin® (Naftifine HCl) Cream 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,053 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Jul 2013
- 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.
- If female and of child-bearing potential, have a negative urine pregnancy test at baseline visit, and prepare to abstain from sexual intercourse or use a reliable method of contraception during the study.
- A total score of at least 4 for the clinical signs and symptoms of tinea pedis for the target lesion. 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 scaling.
- A confirmed clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot.
- The presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic 10% potassium hydroxide wet mount examination.
Who cannot join
- Females who are pregnant, lactating or likely to become pregnant during the study.
- Use of antipruritics, including antihistamines within 72 hours prior to baseline visit.
- Use of topical corticosteroids, antibiotics or antifungal therapies within 2 weeks prior to baseline visit.
- Use of systemic corticosteroids, antibiotics or antifungal therapies within 1 month prior to baseline visit.
- Use of oral terbinafine or itraconazole within 2 months prior to baseline visit.
- Use of immunosuppressive medication or radiation therapy within 3 months prior to baseline visit.
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- Any known hypersensitivity to Naftifine HCl, any component of the formulation or other antifungal agents.
- Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.
- Significant history or current evidence of chronic infectious disease, system disorder, organ disorder, or other medical condition that would place the patient at undue risk by participation or could jeopardize the integrity of the study evaluations.
- Evidence of any concurrent dermatophytic infection of the toe nails or dermatological condition of the foot that may interfere with the evaluation of tinea pedis.
- Patients with a past history of tinea pedis infections with a lack of response to antifungal therapy.
- Patients who would be non-compliant with the requirements of the study protocol.
- Participation in a research study within 30 days prior to baseline visit.
- Employees or family members of employees of the research center or investigator.
- Previous participation in this study.
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, Multiple-Site, Parallel Design Study to Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis.
The objective of this study is to evaluate the efficacy and safety of the test formulation of Naftifine HCl Cream 1% (Taro Pharmaceuticals Inc.) as compared to the already marketed formulation Naftin® (Naftifine HCl) 1% Cream (Merz Pharmaceuticals) and placebo in patients with tinea pedis and to show the superiority of the active treatments over placebo when dosed once a day for 28 days.
- Conditions
- Tinea Pedis
- Being tested
- Naftifine HCl Cream 1%, Naftin® (Naftifine HCl) Cream 1%, Placebo topical cream
- Keywords
- Naftifine HCl Cream 1%, Naftin® (Naftifine HCl) Cream 1%, Tinea Pedis, Efficacy and safety
- Medical subject headings
- Tinea Pedis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naftifine HCl Cream 1%Drug
Naftifine HCl Cream 1% applied topically once a day for 28 days.
Naftin® (Naftifine HCl) Cream 1%Drug
Naftin® (Naftifine HCl) Cream 1% applied topically once a day for 28 days.
Placebo topical creamDrug
Placebo topical cream applied topically once a day for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Naftifine HCl Cream 1% | Experimental | Naftifine HCl Cream 1% (Taro Pharmaceuticals Inc.) Receives: Drug: Naftifine HCl Cream 1% |
| Naftin® (Naftifine HCl) Cream 1% | Active comparator | Naftin® (Naftifine HCl) Cream 1% (Merz Pharmaceuticals) Receives: Drug: Naftin® (Naftifine HCl) Cream 1% |
| Placebo topical cream | Placebo comparator | Placebo topical cream (Taro Pharmaceuticals Inc.) Receives: Drug: Placebo topical cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic Cure
Patients with both mycological cure and clinical cure at the final follow-up visit two weeks fter the end of treatment (Day 42) will be 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 startMay 2012
- Primary completionMar 2013
- Study completionJul 2013
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
- 1,053 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
- NCT01580891
- Sponsor's protocol ID
- NTFC 1105.0
- Status last verified
- May 2014
- First submitted
- 17 Apr 2012
- 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
- Randomized, Double-Blind, Placebo-Controlled, Multiple-Site, Parallel Design Study to Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis.
- ClinicalTrials.gov ID
- NCT01580891
- Acronym / sponsor ID
- NTFC 1105.0
- Conditions
- Tinea Pedis
- Keywords
- Naftifine HCl Cream 1%, Naftin® (Naftifine HCl) Cream 1%, Tinea Pedis, Efficacy and safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,053 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jul 2013 (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 objective of this study is to evaluate the efficacy and safety of the test formulation of Naftifine HCl Cream 1% (Taro Pharmaceuticals Inc.) as compared to the already marketed formulation Naftin® (Naftifine HCl) 1% Cream (Merz Pharmaceuticals) and placebo in patients with tinea pedis and to show the superiority of the active treatments over placebo when dosed once a day for 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Naftifine HCl Cream 1% | Experimental | Drug: Naftifine HCl Cream 1%Naftifine HCl Cream 1% (Taro Pharmaceuticals Inc.) |
| Naftin® (Naftifine HCl) Cream 1% | Active comparator | Drug: Naftin® (Naftifine HCl) Cream 1%Naftin® (Naftifine HCl) Cream 1% (Merz Pharmaceuticals) |
| Placebo topical cream | Placebo comparator | Drug: Placebo topical creamPlacebo topical cream (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 (6 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.
- If female and of child-bearing potential, have a negative urine pregnancy test at baseline visit, and prepare to abstain from sexual intercourse or use a reliable method of contraception during the study.
- A total score of at least 4 for the clinical signs and symptoms of tinea pedis for the target lesion. 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 scaling.
- A confirmed clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot.
Key exclusion criteria (15 listed)
- Females who are pregnant, lactating or likely to become pregnant during the study.
- Use of antipruritics, including antihistamines within 72 hours prior to baseline visit.
- Use of topical corticosteroids, antibiotics or antifungal therapies within 2 weeks prior to baseline visit.
- Use of systemic corticosteroids, antibiotics or antifungal therapies within 1 month prior to baseline visit.
- Use of oral terbinafine or itraconazole within 2 months prior to baseline visit.
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 |
|---|---|---|
| Naftifine HCl Cream 1%Naftifine HCl Cream 1% applied topically once a day for 28 days. | Drug | Naftifine HCl Cream 1% |
| Naftin® (Naftifine HCl) Cream 1%Naftin® (Naftifine HCl) Cream 1% applied topically once a day for 28 days. | Drug | Naftin® (Naftifine HCl) Cream 1% |
| Placebo topical creamPlacebo topical cream applied topically once a day for 28 days. | Drug | Placebo topical cream |
Primary outcome
Therapeutic Cure
Time frame: 42 Days
Patients with both mycological cure and clinical cure at the final follow-up visit two weeks fter the end of treatment (Day 42) will be 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 6 May 2014.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Naftifine HCl Cream 1% and Naftin® (Naftifine HCl) Cream 1% 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 6 inclusion and 15 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 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 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 6 May 2014.