Tinea PedisPhase 1NCT02335255
Evaluate Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® Gel 2% in Tinea Pedis
A Phase 1 study testing Naftifine Hydrochloride Gel 2% and Naftin® Gel 2% in people with Tinea Pedis, run by Sun Pharmaceutical Industries, Inc..
Trial summary
To compare the efficacy and safety of the test formulation Naftifine Hydrochloride Gel 2% to Naftin® (Naftifine Hydrochloride) Gel 2% 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 Gel 2% and Naftin® Gel 2%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,519 participants
- Where
- No sites listed yet
- Study dates
- 27 Jun 2014to 15 May 2018
- 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.
- 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.
- Clinical diagnosis of interdigital 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, confirmed by the observation of segmented fungal hyphae during a microscopic potassium hydroxide wet mount preparation.
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 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 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 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 investigator's evaluation of tinea pedis.
- Patients with a past history of dermatophyte infections with a lack of response to antifungal therapy.
About this study
Official title: A Multi-Center, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® (Naftifine Hydrochloride) Gel 2% in Patients With Tinea Pedis.
To compare the efficacy and safety of the test formulation Naftifine Hydrochloride Gel 2% to Naftin® (Naftifine Hydrochloride) Gel 2%
Read the detailed description
The purpose of this study is to compare the efficacy and safety of the test formulation Naftifine Hydrochloride Gel 2% to Naftin® (Naftifine Hydrochloride) Gel 2% in a six week study (four weeks after the end of two week treatment) in patients with tinea pedis.
- Conditions
- Tinea Pedis
- Being tested
- Naftifine Hydrochloride Gel 2%, Naftin® Gel 2%, Placebo Topical Gel
- 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 Gel 2%Drug
Also called Naftifine
Naftifine Hydrochloride Gel 2% applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin.
Naftin® Gel 2%Drug
Also called Naftifine
Naftin® Gel 2% applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin.
Placebo Topical GelDrug
Also called Vehicle
Placebo Topical Gel applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin.
| Study group | Role | What they receive |
|---|---|---|
| Naftifine Hydrochloride Gel 2% | Experimental | Naftifine Hydrochloride Gel 2% (Taro Pharmaceuticals Inc.) Receives: Drug: Naftifine Hydrochloride Gel 2% |
| Naftin® Gel 2% | Active comparator | Naftin® (Naftifine Hydrochloride) Gel 2% (Merz Pharmaceuticals, LLC) Receives: Drug: Naftin® Gel 2% |
| Placebo Topical Gel | Placebo comparator | Placebo Topical Gel (Taro Pharmaceuticals Inc.) Receives: Drug: Placebo Topical Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic cure after end of treatment
The proportion of subjects with therapeutic cure, defined as both mycological cure and clinical cure, at the test-of-cure visit conducted four weeks after the end of treatment (study day 38-46).
Measured: Study day 38-46
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2015 (estimated)
- Study start27 Jun 2014
- Primary completion15 May 2018
- Study completion15 May 2018
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,519 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/
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02335255
- Sponsor's protocol ID
- NFTC 1409-1722
- Status last verified
- Sep 2018
- First submitted
- 7 Jan 2015
- Last updated
- 6 Sep 2018
- 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 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® (Naftifine Hydrochloride) Gel 2% in Patients With Tinea Pedis.
- ClinicalTrials.gov ID
- NCT02335255
- Acronym / sponsor ID
- NFTC 1409-1722
- Conditions
- Tinea Pedis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,519 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jun 2014 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 15 May 2018 (actual)
- First posted
- 9 Jan 2015 (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 compare the efficacy and safety of the test formulation Naftifine Hydrochloride Gel 2% to Naftin® (Naftifine Hydrochloride) Gel 2%
Detailed description
The purpose of this study is to compare the efficacy and safety of the test formulation Naftifine Hydrochloride Gel 2% to Naftin® (Naftifine Hydrochloride) Gel 2% in a six week study (four weeks after the end of two week treatment) in patients with tinea pedis.
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 |
|---|---|---|
| Naftifine Hydrochloride Gel 2% | Experimental | Drug: Naftifine Hydrochloride Gel 2%Naftifine Hydrochloride Gel 2% (Taro Pharmaceuticals Inc.) |
| Naftin® Gel 2% | Active comparator | Drug: Naftin® Gel 2%Naftin® (Naftifine Hydrochloride) Gel 2% (Merz Pharmaceuticals, LLC) |
| Placebo Topical Gel | Placebo comparator | Drug: Placebo Topical GelPlacebo Topical Gel (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 (4 listed)
- Male or non-pregnant, non-lactating females 18 years of age or older.
- 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.
- Clinical diagnosis of interdigital 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, confirmed by the observation of segmented fungal hyphae during a microscopic potassium hydroxide wet mount preparation.
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 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 Hydrochloride Gel 2%Also: NaftifineNaftifine Hydrochloride Gel 2% applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin. | Drug | Naftifine Hydrochloride Gel 2% |
| Naftin® Gel 2%Also: NaftifineNaftin® Gel 2% applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin. | Drug | Naftin® Gel 2% |
| Placebo Topical GelAlso: VehiclePlacebo Topical Gel applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin. | Drug | Placebo Topical Gel |
Primary outcome
Therapeutic cure after end of treatment
Time frame: Study day 38-46
The proportion of subjects with therapeutic cure, defined as both mycological cure and clinical cure, at the test-of-cure visit conducted four weeks after the end of treatment (study day 38-46).
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 Sep 2018.
- 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/
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Naftifine Hydrochloride Gel 2% and Naftin® Gel 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 6 Sep 2018. 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 after end of treatment (time frame: Study day 38-46). 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 Sep 2018.