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

• ClinicalTrials.gov Identifier: NCT01580891
• Recruitment Status: Completed
• First Posted: April 19, 2012
• Last Update Posted: May 6, 2014
• Sponsor: Taro Pharmaceuticals USA
• Information provided by (Responsible Party): Taro Pharmaceuticals USA

Tracking Information

• First Submitted Date: April 17, 2012
• First Posted Date: April 19, 2012
• Last Update Posted Date: May 6, 2014
• Study Start Date: May 2012
• Actual Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 18, 2012)

Therapeutic Cure [ Time Frame: 42 Days ]

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (submitted: April 18, 2012)

• Clinical Cure [ Time Frame: 42 Days ]
  Secondary endpoints include proportion of patients considered a clinical cure at day 42.
• Mycological Cure [ Time Frame: 42 Days ]
  Secondary endpoints will include proportion of patients considered a mycological cure at day 42.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis
• 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.
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Tinea Pedis

Intervention

• 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.

Study Arms

• 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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 19, 2013): 1053
• Original Estimated Enrollment (submitted: April 18, 2012): 750
• Actual Study Completion Date: July 2013
• Actual Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: Belize, United States

Administrative Information

• NCT Number: NCT01580891
• Other Study ID Numbers: NTFC 1105.0
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Taro Pharmaceuticals USA
• Original Responsible Party: Same as current
• Current Study Sponsor: Taro Pharmaceuticals USA
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Taro Pharmaceuticals USA
• Verification Date: May 2014