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CompletedNCT02132260Updated May 9, 2017

Evaluate the Safety and Efficacy of Naftifine Hydrochloride Cream 2% and Naftin® Cream 2% in Patients With Tinea Pedis

A Phase 1 interventional study of Naftifine Hydrochloride Cream 2% and Naftin® (Naftifine Hydrochloride) Cream 2% in Tinea Pedis, sponsored by Taro Pharmaceuticals USA. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-09.

Sponsored by Taro Pharmaceuticals USA (part of Sun Pharmaceutical Industries Limited) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
890
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Tinea Pedis

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Keywords

  • Naftifine
  • Naftin®
  • Tinea pedis
03

In context

Tinea Pedis

73 studies on the registry are indexed under Tinea Pedis; 8 are open to participants now.

This study's enrollment of 890 is above the median of 128 across 66 interventional studies indexed under Tinea Pedis.

Browse Tinea Pedis studies →

Lead sponsor

Taro Pharmaceuticals USA is the lead sponsor of 71 studies on the registry; none are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 1 (5%) have results posted.

First submitted after Taro Pharmaceuticals USA became part of Sun Pharmaceutical Industries Limited.

Browse Taro Pharmaceuticals USA studies →All Sun Pharmaceutical Industries Limited studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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 , 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 medication or radiation therapy within three months prior to baseline visit
  • Any known 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
890 participants (actual)

Study arms

  • Experimental
    Naftifine Hydrochloride Cream 2%

    Naftifine Hydrochloride Cream 2% (Taro Pharmaceuticals Inc.)

    Drug: Naftifine Hydrochloride Cream 2%

  • Active comparator
    Naftin® Cream 2%

    Naftin® (Naftifine Hydrochloride) Cream 2%

    Drug: Naftin® (Naftifine Hydrochloride) Cream 2%

  • Placebo comparator
    Placebo Topical Cream

    Placebo Topical Cream

    Drug: Placebo Topical Cream

Interventions

  • DrugNaftifine Hydrochloride Cream 2%

    Naftifine Hydrochloride Cream 2% (Taro Pharmaceuticals Inc.) applied once-daily for two weeks

    Also known as: Naftifine

  • DrugNaftin® (Naftifine Hydrochloride) Cream 2%

    Naftin® (Naftifine Hydrochloride) Cream 2% (Merz Pharmaceuticals, LLC) applied once-daily for two weeks.

    Also known as: Naftifine

  • DrugPlacebo Topical Cream

    Placebo Topical Cream (Taro Pharmaceuticals Inc.) applied once-daily for two weeks.

    Also known as: vehicle

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2013, a primary completion of Feb 2014 and a completion of Mar 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 5, 2014
First posted
May 7, 2014
Start
Aug 2013
Primary completionActual
Feb 2014
CompletionActual
Mar 2014
Last update
May 9, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02132260
Lead sponsor
Taro Pharmaceuticals USA
Responsible party
Sponsor
First posted
May 7, 2014
Start date
Aug 2013
Primary completion
Feb 2014
Completion
Mar 2014
Last update
May 9, 2017

Study contacts

Catawba Research
study chair · http://catawbaresearch.com/contact/
Natalie Yantovskiy
study director · Taro Pharmaceuticals USA Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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