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

April 17, 2012
May 5, 2014
May 2012
March 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01580891 on ClinicalTrials.gov Archive Site
Not Provided
  • Clinical Cure [ Time Frame: 42 Days ] [ Designated as safety issue: No ]
    Secondary endpoints include proportion of patients considered a clinical cure at day 42.
  • Mycological Cure [ Time Frame: 42 Days ] [ Designated as safety issue: No ]
    Secondary endpoints will include proportion of patients considered a mycological cure at day 42.
Not Provided
Not Provided
 
Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis
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.

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Tinea Pedis
  • Drug: Naftifine HCl Cream 1%
    Naftifine HCl Cream 1% applied topically once a day for 28 days.
  • Drug: Naftin® (Naftifine HCl) Cream 1%
    Naftin® (Naftifine HCl) Cream 1% applied topically once a day for 28 days.
  • Drug: Placebo topical cream
    Placebo topical cream applied topically once a day for 28 days.
  • Experimental: Naftifine HCl Cream 1%
    Naftifine HCl Cream 1% (Taro Pharmaceuticals Inc.)
    Intervention: Drug: Naftifine HCl Cream 1%
  • Active Comparator: Naftin® (Naftifine HCl) Cream 1%
    Naftin® (Naftifine HCl) Cream 1% (Merz Pharmaceuticals)
    Intervention: Drug: Naftin® (Naftifine HCl) Cream 1%
  • Placebo Comparator: Placebo topical cream
    Placebo topical cream (Taro Pharmaceuticals Inc.)
    Intervention: Drug: Placebo topical cream
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1053
July 2013
March 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01580891
NTFC 1105.0
No
Taro Pharmaceuticals USA
Taro Pharmaceuticals USA
Not Provided
Not Provided
Taro Pharmaceuticals USA
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP