Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT01580891
First received: April 17, 2012
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

The objective of this study is to evaluate the efficacy and safety of the test formulation of Naftifine HCl Cream 1% (Taro Pharmaceuticals Inc.) as compared to the already marketed formulation Naftin® (Naftifine HCl) 1% Cream (Merz Pharmaceuticals) and placebo in patients with tinea pedis and to show the superiority of the active treatments over placebo when dosed once a day for 28 days.


Condition Intervention Phase
Tinea Pedis
Drug: Naftifine HCl Cream 1%
Drug: Naftin® (Naftifine HCl) Cream 1%
Drug: Placebo topical cream
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled, Multiple-Site, Parallel Design Study to Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis.

Resource links provided by NLM:


Further study details as provided by Taro Pharmaceuticals USA:

Primary Outcome Measures:
  • Therapeutic Cure [ Time Frame: 42 Days ] [ Designated as safety issue: No ]
    Patients with both mycological cure and clinical cure at the final follow-up visit two weeks fter the end of treatment (Day 42) will be considered therapeutic cures.


Enrollment: 1053
Study Start Date: May 2012
Study Completion Date: July 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Naftifine HCl Cream 1%
Naftifine HCl Cream 1% (Taro Pharmaceuticals Inc.)
Drug: Naftifine HCl Cream 1%
Naftifine HCl Cream 1% applied topically once a day for 28 days.
Active Comparator: Naftin® (Naftifine HCl) Cream 1%
Naftin® (Naftifine HCl) Cream 1% (Merz Pharmaceuticals)
Drug: Naftin® (Naftifine HCl) Cream 1%
Naftin® (Naftifine HCl) Cream 1% applied topically once a day for 28 days.
Placebo Comparator: Placebo topical cream
Placebo topical cream (Taro Pharmaceuticals Inc.)
Drug: Placebo topical cream
Placebo topical cream applied topically once a day for 28 days.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or non-pregnant, non-lactating females 18 years of age or older.
  • Signed informed consent form, which meets all criteria of current FDA regulations.
  • If female and of child-bearing potential, have a negative urine pregnancy test at baseline visit, and prepare to abstain from sexual intercourse or use a reliable method of contraception during the study.
  • A total score of at least 4 for the clinical signs and symptoms of tinea pedis for the target lesion. In addition, the most infected area must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for scaling.
  • A confirmed 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 tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic 10% potassium hydroxide wet mount examination.

Exclusion Criteria:

  • Females who are pregnant, lactating or likely to become pregnant during the study.
  • 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.
  • Any known hypersensitivity to Naftifine HCl, any component of the formulation or other antifungal agents.
  • Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.
  • Significant history or current evidence of chronic infectious disease, system disorder, organ disorder, or other medical condition that would place the 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 evaluation of tinea pedis.
  • Patients with a past history of tinea pedis infections with a lack of response to antifungal therapy.
  • Patients who would be non-compliant with the requirements of the study protocol.
  • Participation in a research study within 30 days prior to baseline visit.
  • Employees or family members of employees of the research center or investigator.
  • Previous participation in this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT01580891     History of Changes
Other Study ID Numbers: NTFC 1105.0
Study First Received: April 17, 2012
Last Updated: May 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Taro Pharmaceuticals USA:
Naftifine HCl Cream 1%
Naftin® (Naftifine HCl) Cream 1%
Tinea Pedis
Efficacy and safety

Additional relevant MeSH terms:
Tinea
Tinea Pedis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Foot Dermatoses
Foot Diseases
Pruritus
Skin Manifestations
Signs and Symptoms
Naftifine
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014