Tinea PedisPhase 1NCT02132260
Evaluate the Safety and Efficacy of Naftifine Hydrochloride Cream 2% and Naftin® Cream 2% in Patients With Tinea Pedis
A Phase 1 study testing Naftifine Hydrochloride Cream 2% and Naftin® (Naftifine Hydrochloride) Cream 2% in people with Tinea Pedis, run by Sun Pharmaceutical Industries, Inc..
Trial summary
The objective of this study is to compare the efficacy and safety of the test formulation of Naftifine Hydrochloride Cream 2% to Naftin® (Naftifine Hydrochloride) 2% Cream in a 6 week study in patients with 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?
- Naftifine Hydrochloride Cream 2% and Naftin® (Naftifine Hydrochloride) Cream 2%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 890 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Mar 2014
- 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 or older
- 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 interdigital tinea pedis infection
- The sum of the clinical signs and symptoms scores of the target lesion is at least 4, including a minimum score of at least 2 for erythema and a minimum score of 2 for either scaling or pruritus
Who cannot join
- Females who are pregnant, lactating or planning to become pregnant during the study period
- Use of antipruritics, including antihistamines within 72 hours prior to baseline visit
- Use of topical corticosteroids, antibiotics or antifungal therapies within two weeks prior to baseline visit
- Use of systemic corticosteroids, antibiotics or antifungal therapies within one month prior to baseline visit
- Use of oral terbinafine or itraconazole within two months prior to baseline visit
- Use of immunosuppressive medication or radiation therapy within three months prior to baseline visit
Show all 11Show fewer
- Any known hypersensitivity to Naftifine Hydrochloride, or any component of the formulation
- Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface
- History of significant or current evidence of chronic infectious disease, system disorder, organ disorder, or other medical condition that would place undue risk by participation or could jeopardize the integrity of study evaluations
- Evidence of any concurrent dermatophytic infection of the toe nails or dermatological condition of the foot that may interfere with tinea pedis evaluation
- Past history of dermatophyte infections with a lack of response ot antifungal therapy
About this study
Official title: A Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate the Safety and Efficacy of a Naftifine Hydrochloride Cream 2%and the Naftin® Cream 2% in Patients With Tinea Pedis
The objective of this study is to compare the efficacy and safety of the test formulation of Naftifine Hydrochloride Cream 2% to Naftin® (Naftifine Hydrochloride) 2% Cream in a 6 week study in patients with tinea pedis.
- Conditions
- Tinea Pedis
- Being tested
- Naftifine Hydrochloride Cream 2%, Naftin® (Naftifine Hydrochloride) Cream 2%, Placebo Topical Cream
- Keywords
- Naftifine, Naftin®, 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.
Naftifine Hydrochloride Cream 2%Drug
Also called Naftifine
Naftifine Hydrochloride Cream 2% (Taro Pharmaceuticals Inc.) applied once-daily for two weeks
Naftin® (Naftifine Hydrochloride) Cream 2%Drug
Also called Naftifine
Naftin® (Naftifine Hydrochloride) Cream 2% (Merz Pharmaceuticals, LLC) applied once-daily for two weeks.
Placebo Topical CreamDrug
Also called vehicle
Placebo Topical Cream (Taro Pharmaceuticals Inc.) applied once-daily for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Naftifine Hydrochloride Cream 2% | Experimental | Naftifine Hydrochloride Cream 2% (Taro Pharmaceuticals Inc.) Receives: Drug: Naftifine Hydrochloride Cream 2% |
| Naftin® Cream 2% | Active comparator | Naftin® (Naftifine Hydrochloride) Cream 2% Receives: Drug: Naftin® (Naftifine Hydrochloride) Cream 2% |
| Placebo Topical Cream | Placebo comparator | Placebo Topical Cream Receives: Drug: Placebo Topical Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic Cure
The proportion of subjects with therapeutic cure (both mycological cure and clinical cure) at the test-of-cure visit conducted four weeks after the end of treatment.
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 posted7 May 2014 (estimated)
- Study startAug 2013
- Primary completionFeb 2014
- Study completionMar 2014
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
- 890 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Catawba Research, Study chair, http://catawbaresearch.com/contact/Natalie Yantovskiy, Study director, Taro Pharmaceuticals USA Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132260
- Sponsor's protocol ID
- NFTC 1301
- Status last verified
- May 2017
- First submitted
- 5 May 2014
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate the Safety and Efficacy of a Naftifine Hydrochloride Cream 2%and the Naftin® Cream 2% in Patients With Tinea Pedis
- ClinicalTrials.gov ID
- NCT02132260
- Acronym / sponsor ID
- NFTC 1301
- Conditions
- Tinea Pedis
- Keywords
- Naftifine, Naftin®, Tinea pedis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 890 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 7 May 2014 (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 compare the efficacy and safety of the test formulation of Naftifine Hydrochloride Cream 2% to Naftin® (Naftifine Hydrochloride) 2% Cream in a 6 week study in patients with tinea pedis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Naftifine Hydrochloride Cream 2% | Experimental | Drug: Naftifine Hydrochloride Cream 2%Naftifine Hydrochloride Cream 2% (Taro Pharmaceuticals Inc.) |
| Naftin® Cream 2% | Active comparator | Drug: Naftin® (Naftifine Hydrochloride) Cream 2%Naftin® (Naftifine Hydrochloride) Cream 2% |
| Placebo Topical Cream | Placebo comparator | Drug: Placebo Topical CreamPlacebo Topical Cream |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or non-pregnant, non-lactating females 18 years or older
- 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 interdigital tinea pedis infection
- The sum of the clinical signs and symptoms scores of the target lesion is at least 4, including a minimum score of at least 2 for erythema and a minimum score of 2 for either scaling or pruritus
Key exclusion criteria (11 listed)
- Females who are pregnant, lactating or planning to become pregnant during the study period
- Use of antipruritics, including antihistamines within 72 hours prior to baseline visit
- Use of topical corticosteroids, antibiotics or antifungal therapies within two weeks prior to baseline visit
- Use of systemic corticosteroids, antibiotics or antifungal therapies within one month prior to baseline visit
- Use of oral terbinafine or itraconazole within two 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 Hydrochloride Cream 2%Also: NaftifineNaftifine Hydrochloride Cream 2% (Taro Pharmaceuticals Inc.) applied once-daily for two weeks | Drug | Naftifine Hydrochloride Cream 2% |
| Naftin® (Naftifine Hydrochloride) Cream 2%Also: NaftifineNaftin® (Naftifine Hydrochloride) Cream 2% (Merz Pharmaceuticals, LLC) applied once-daily for two weeks. | Drug | Naftin® Cream 2% |
| Placebo Topical CreamAlso: vehiclePlacebo Topical Cream (Taro Pharmaceuticals Inc.) applied once-daily for two weeks. | Drug | Placebo Topical Cream |
Primary outcome
Therapeutic Cure
Time frame: 6 weeks
The proportion of subjects with therapeutic cure (both mycological cure and clinical cure) at the test-of-cure visit conducted four weeks after the end of treatment.
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 9 May 2017.
- Individual participant dataSharing planned: No
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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.
Catawba Research study chair
http://catawbaresearch.com/contact/
Natalie Yantovskiy study director
Taro Pharmaceuticals USA Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Naftifine Hydrochloride Cream 2% and Naftin® (Naftifine Hydrochloride) Cream 2% 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 4 inclusion and 11 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 9 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: 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 9 May 2017.