Tinea PedisPhase 3NCT02633813
BE Study of Naftifine HCL
A Phase 3 study testing Naftifine hydrochloride 2% and Naftin® 2% (Naftifine hydrochloride 2%) in people with Tinea Pedis, run by Genzum Life Sciences at 14 sites in 2 countries.
Trial summary
The current study was randomized, double blind, placebo-controlled, prospective, multicenter, comparative therapeutic equivalence study. The study duration for each patient was 6 weeks: Following were the visit details. V1-Baseline and Randomization Visit (Day 1). 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 2% and Naftin® 2% (Naftifine hydrochloride 2%)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 693 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Mar 2015to Dec 2015
- Phase
- Phase 3
- 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
- Healthy males and females aged more than or equal to 18 years
- 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 non-interdigital lesions should not be hyperkeratotic, i.e., characteristic of tinea pedis moccasin), and provisionally confirmed at baseline by a positive potassium hydroxide (KOH) wet mount preparation (i.e., skin scrapings from the target site are placed on a microscope slide with a drop of 10% KOH, and microscopic examination reveals segmented fungal hyphae)
- 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 (on a scale of 0-3, where 2 indicates moderate severity)
Who cannot join
- Pregnant or lactating or planning to become pregnant during the study period
- Use of antipruritics, including antihistamines, within 72 hours prior to entry into the study
- Use of topical corticosteroid, antibiotics or antifungal therapy within 2 weeks prior to entry into the study
- Use of systemic (e.g., oral or injectable) corticosteroid, antibiotics or antifungal therapy within 1 month prior to entry into the study
- Use of oral terbinafine or itraconazole within 2 months prior to entry into the study
- Use of immunosuppressive medication or radiation therapy within 3 months prior to entry into the study.
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- Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.
- Presence of any other infection of the foot or other disease process that might confound the treatment evaluation
- History of dermatophyte infections unresponsive to systemic or topical antifungal drugs
- Known hypersensitivity to Naftifine Hydrochloride or to any component of the formulation
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States12 sites
Bellaire Dermatology Associates
Bellaire, Texas, 77401
Moore Clinical Research Inc
Brandon, Florida, 33511
Research Across America
Dallas, Texas, 75234
Family Practise
Mesquite, Texas, 75149
Savin Medical Group Research
Miami, Florida, 33014
International Dermatology Research, Inc,
Miami, Florida, 33144
FXM Research Corp
Miami, Florida, 33175
FXM Research Miramar
Miramar, Florida, 33027
Research Across America
Plano, Texas, 75093
Medi Search
Saint Joseph, Missouri, 64506
South Tampa, MOORE Clinical Research, Inc.
Tampa, Florida, 33609
North Tampa MOORE Clinical Research, Inc.
Tampa, Florida, 33618
Dominican Republic2 sites
Instituto Dermatológico
Barrio Maria Auxiliadora, Santo Domingo Province, 10305
Instituto Dermatológico y Cirugía de Piel
Santo Domingo, San Cristóbal, 91000
About this study
Official title: A Randomized, Prospective Multicenter, Double Blind, Parallel Assignment Placebo Controlled BE Study Of Naftifine Hydrochloride 2% Topical Cream With Naftin® In Patients With Tinea Pedis Using Clinical Endpoints
The current study was randomized, double blind, placebo-controlled, prospective, multicenter, comparative therapeutic equivalence study.
The study duration for each patient was 6 weeks: Following were the visit details.
V1-Baseline and Randomization Visit (Day 1). V2- End of therapy visit (at the end of week 2 + 2 days). V3- Follow up visit (at the end of week 4 + 2 days). V4 - Test of cure visit ( at the end of week 6 + 4 days).
- Conditions
- Tinea Pedis
- Being tested
- Naftifine hydrochloride 2%, Placebo, Naftin® 2% (Naftifine hydrochloride 2%)
- Keywords
- Bioequivalence, Tinea pedis, Naftin
- 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 2%Drug
Also called Naftifine hcl
Topical application for two weeks
PlaceboDrug
Also called Vehicle cream
Topical application for two weeks
Naftin® 2% (Naftifine hydrochloride 2%)Drug
Also called Naftifine hcl
Topical application for two weeks
| Study group | Role | What they receive |
|---|---|---|
| Naftifine hydrochloride 2% | Experimental | A thin layer of sufficient quantity of Naftifine hydrochloride cream need to be applied to the affected areas plus an approximate ½ inch margin of healthy surrounding skin once daily consecutively for 2 weeks. Receives: Drug: Naftifine hydrochloride 2% |
| Naftin® 2% (Naftifine hydrochloride 2%) | Active comparator | A thin layer of sufficient quantity of Naftifine hydrochloride cream need to be applied to the affected areas plus an approximate ½ inch margin of healthy surrounding skin once daily consecutively for 2 weeks. Receives: Drug: Naftin® 2% (Naftifine hydrochloride 2%) |
| Placebo vehicle cream. | Placebo comparator | A thin layer of sufficient quantity of vehicle cream need to be applied to the affected areas plus an approximate ½ inch margin of healthy surrounding skin once daily consecutively for 2 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mycological cure and clinical cure for a single target lesion for Trichyphyton rubrum
After 6 weeks the skin scrapping will be collected for culture to find out the growth of T rubrum. Absence of growth suggests complete cure.
Measured: week 6 + 4 days
Secondary outcomes (1)
Mycological cure and clinical cure for Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum
After 6 weeks the skin scrapping will be collected for culture to find out the growth of T rubrum, T Mentagrophytes or E floccosum. Absence of growth suggests complete cure.
Measured: week 6 + 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startMar 2015
- Primary completionNov 2015
- Study completionDec 2015
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 693 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzum Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zaidoon Al-Zubaidy, Study chair, Catawba Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633813
- Sponsor's protocol ID
- CD-13-661
- Status last verified
- May 2017
- First submitted
- 11 Dec 2015
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective Multicenter, Double Blind, Parallel Assignment Placebo Controlled BE Study Of Naftifine Hydrochloride 2% Topical Cream With Naftin® In Patients With Tinea Pedis Using Clinical Endpoints
- ClinicalTrials.gov ID
- NCT02633813
- Acronym / sponsor ID
- CD-13-661
- Conditions
- Tinea Pedis
- Keywords
- Bioequivalence, Tinea pedis, Naftin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 693 participants (actual)
- Lead sponsor
- Genzum Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Dec 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.
The current study was randomized, double blind, placebo-controlled, prospective, multicenter, comparative therapeutic equivalence study.
The study duration for each patient was 6 weeks: Following were the visit details.
V1-Baseline and Randomization Visit (Day 1). V2- End of therapy visit (at the end of week 2 + 2 days). V3- Follow up visit (at the end of week 4 + 2 days). V4 - Test of cure visit ( at the end of week 6 + 4 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 hydrochloride 2% | Experimental | Drug: Naftifine hydrochloride 2%A thin layer of sufficient quantity of Naftifine hydrochloride cream need to be applied to the affected areas plus an approximate ½ inch margin of healthy surrounding skin once daily consecutively for 2 weeks. |
| Naftin® 2% (Naftifine hydrochloride 2%) | Active comparator | Drug: Naftin® 2% (Naftifine hydrochloride 2%)A thin layer of sufficient quantity of Naftifine hydrochloride cream need to be applied to the affected areas plus an approximate ½ inch margin of healthy surrounding skin once daily consecutively for 2 weeks. |
| Placebo vehicle cream. | Placebo comparator | Drug: PlaceboA thin layer of sufficient quantity of vehicle cream need to be applied to the affected areas plus an approximate ½ inch margin of healthy surrounding skin once daily consecutively for 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy males and females aged more than or equal to 18 years
- 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 non-interdigital lesions should not be hyperkeratotic, i.e., characteristic of tinea pedis moccasin), and provisionally confirmed at baseline by a positive potassium hydroxide (KOH) wet mount preparation (i.e., skin scrapings from the target site are placed on a microscope slide with a drop of 10% KOH, and microscopic examination reveals segmented fungal hyphae)
- 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 (on a scale of 0-3, where 2 indicates moderate severity)
Key exclusion criteria (10 listed)
- Pregnant or lactating or planning to become pregnant during the study period
- Use of antipruritics, including antihistamines, within 72 hours prior to entry into the study
- Use of topical corticosteroid, antibiotics or antifungal therapy within 2 weeks prior to entry into the study
- Use of systemic (e.g., oral or injectable) corticosteroid, antibiotics or antifungal therapy within 1 month prior to entry into the study
- Use of oral terbinafine or itraconazole within 2 months prior to entry into the study
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 2%Also: Naftifine hclTopical application for two weeks | Drug | Naftifine hydrochloride 2% |
| PlaceboAlso: Vehicle creamTopical application for two weeks | Drug | Placebo vehicle cream. |
| Naftin® 2% (Naftifine hydrochloride 2%)Also: Naftifine hclTopical application for two weeks | Drug | Naftin® 2% (Naftifine hydrochloride 2%) |
Primary outcome
Mycological cure and clinical cure for a single target lesion for Trichyphyton rubrum
Time frame: week 6 + 4 days
After 6 weeks the skin scrapping will be collected for culture to find out the growth of T rubrum. Absence of growth suggests complete cure.
1 secondary outcome
Mycological cure and clinical cure for Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum
Time frame: week 6 + 4 days
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 11 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
Zaidoon Al-Zubaidy study chair
Catawba Research
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Naftifine hydrochloride 2% and Naftin® 2% (Naftifine hydrochloride 2%) in people with Tinea Pedis, run by Genzum Life Sciences at 14 sites in 2 countries.
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 3 inclusion and 10 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 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Dominican Republic. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Mycological cure and clinical cure for a single target lesion for Trichyphyton rubrum (time frame: week 6 + 4 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 11 May 2017.