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CompletedNCT02335255Updated Sep 6, 2018

Evaluate Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® Gel 2% in Tinea Pedis

A Phase 1 interventional study of Naftifine Hydrochloride Gel 2% and Naftin® Gel 2% in Tinea Pedis, sponsored by Taro Pharmaceuticals USA. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-06.

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

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Jun 2014, registered Jan 2015).
Phase
Phase 1
Study type
Interventional
Enrollment
1,519
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Tinea Pedis

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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 1,519 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.

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 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.

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 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 medication or radiation therapy within 3 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 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.
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
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,519 participants (actual)

Study arms

  • Experimental
    Naftifine Hydrochloride Gel 2%

    Naftifine Hydrochloride Gel 2% (Taro Pharmaceuticals Inc.)

    Drug: Naftifine Hydrochloride Gel 2%

  • Active comparator
    Naftin® Gel 2%

    Naftin® (Naftifine Hydrochloride) Gel 2% (Merz Pharmaceuticals, LLC)

    Drug: Naftin® Gel 2%

  • Placebo comparator
    Placebo Topical Gel

    Placebo Topical Gel (Taro Pharmaceuticals Inc.)

    Drug: Placebo Topical Gel

Interventions

  • Naftifine Hydrochloride Gel 2% applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin.

    Also known as: Naftifine

  • Naftin® Gel 2% applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin.

    Also known as: Naftifine

  • DrugPlacebo Topical Gel

    Placebo Topical Gel applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin.

    Also known as: Vehicle

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Study day 38-46

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

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02335255
Responsible party
Sponsor
First posted
Jan 9, 2015
Start date
Jun 27, 2014
Primary completion
May 15, 2018
Completion
May 15, 2018
Last update
Sep 6, 2018

Study contacts

Catawba Research
study chair · http://catawbaresearch.com/contact/

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 Sep 2018. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Naftifine

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