BE Study of Naftifine HCL

A Randomized, Prospective Multicenter, Double Blind, Parallel Assignment Placebo Controlled BE Study Of Naftifine Hydrochloride 2% Topical Cream With Naftin® In Patients With Tinea Pedis Using Clinical Endpoints

The current study was randomized, double blind, placebo-controlled, prospective, multicenter, comparative therapeutic equivalence study.

The study duration for each patient was 6 weeks: Following were the visit details.

V1-Baseline and Randomization Visit (Day 1). V2- End of therapy visit (at the end of week 2 + 2 days). V3- Follow up visit (at the end of week 4 + 2 days). V4 - Test of cure visit ( at the end of week 6 + 4 days).

Study Overview

• Status: Completed
• Conditions: Tinea Pedis
• Intervention / Treatment: Drug: Naftifine hydrochloride 2%; Drug: Naftin® 2% (Naftifine hydrochloride 2%); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 693
• Phase: Phase 3

Contacts and Locations

Study Locations

• Dominican Republic
  • San Cristóbal
    • Santo Domingo, San Cristóbal, Dominican Republic, 91000
      • Instituto Dermatologico y Cirugia de Piel
  • Santo Domingo
    • Barrio Maria Auxiliadora, Santo Domingo, Dominican Republic, 10305
      • Instituto Dermatológico
• United States
  • Florida
    • Brandon, Florida, United States, 33511
      • Moore Clinical Research Inc
    • Miami, Florida, United States, 33175
      • FXM Research Corp
    • Miami, Florida, United States, 33014
      • Savin Medical Group Research
    • Miami, Florida, United States, 33144
      • International Dermatology Research, Inc,
    • Miramar, Florida, United States, 33027
      • FXM Research Miramar
    • Tampa, Florida, United States, 33609
      • South Tampa, MOORE Clinical Research, Inc.
    • Tampa, Florida, United States, 33618
      • North Tampa MOORE Clinical Research, Inc.
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Medi Search
  • Texas
    • Bellaire, Texas, United States, 77401
      • Bellaire Dermatology Associates
    • Dallas, Texas, United States, 75234
      • Research Across America
    • Mesquite, Texas, United States, 75149
      • Family Practise
    • Plano, Texas, United States, 75093
      • Research Across America

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy males and females aged more than or equal to 18 years
2. 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 non-interdigital lesions should not be hyperkeratotic, i.e., characteristic of tinea pedis moccasin), and provisionally confirmed at baseline by a positive potassium hydroxide (KOH) wet mount preparation (i.e., skin scrapings from the target site are placed on a microscope slide with a drop of 10% KOH, and microscopic examination reveals segmented fungal hyphae)
3. 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 (on a scale of 0-3, where 2 indicates moderate severity)

Exclusion Criteria:

1. Pregnant or lactating or planning to become pregnant during the study period
2. Use of antipruritics, including antihistamines, within 72 hours prior to entry into the study
3. Use of topical corticosteroid, antibiotics or antifungal therapy within 2 weeks prior to entry into the study
4. Use of systemic (e.g., oral or injectable) corticosteroid, antibiotics or antifungal therapy within 1 month prior to entry into the study
5. Use of oral terbinafine or itraconazole within 2 months prior to entry into the study
6. Use of immunosuppressive medication or radiation therapy within 3 months prior to entry into the study.
7. Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.
8. Presence of any other infection of the foot or other disease process that might confound the treatment evaluation
9. History of dermatophyte infections unresponsive to systemic or topical antifungal drugs
10. Known hypersensitivity to Naftifine Hydrochloride or to any component of the formulation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Naftifine hydrochloride 2%; A thin layer of sufficient quantity of Naftifine hydrochloride cream need to be applied to the affected areas plus an approximate ½ inch margin of healthy surrounding skin once daily consecutively for 2 weeks.	Drug: Naftifine hydrochloride 2%; Topical application for two weeks; Other Names: Naftifine hcl
Active Comparator: Naftin® 2% (Naftifine hydrochloride 2%); A thin layer of sufficient quantity of Naftifine hydrochloride cream need to be applied to the affected areas plus an approximate ½ inch margin of healthy surrounding skin once daily consecutively for 2 weeks.	Drug: Naftin® 2% (Naftifine hydrochloride 2%); Topical application for two weeks; Other Names: Naftifine hcl
Placebo Comparator: Placebo vehicle cream.; A thin layer of sufficient quantity of vehicle cream need to be applied to the affected areas plus an approximate ½ inch margin of healthy surrounding skin once daily consecutively for 2 weeks.	Drug: Placebo; Topical application for two weeks; Other Names: Vehicle cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mycological cure and clinical cure for a single target lesion for Trichyphyton rubrum	After 6 weeks the skin scrapping will be collected for culture to find out the growth of T rubrum. Absence of growth suggests complete cure.	week 6 + 4 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mycological cure and clinical cure for Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum	After 6 weeks the skin scrapping will be collected for culture to find out the growth of T rubrum, T Mentagrophytes or E floccosum. Absence of growth suggests complete cure.	week 6 + 4 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of AEs for each treatment groups	number of adverse events reported will be collated from all the treatment arms, to evaluate the safety of the study drugs.	week 6 + 4 days

Collaborators and Investigators

• Sponsor: Genzum Life Sciences
• Investigators: Study Chair: Zaidoon Al-Zubaidy, Catawba Research

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: December 11, 2015
• First Submitted That Met QC Criteria: December 16, 2015
• First Posted (Estimate): December 17, 2015

Study Record Updates

• Last Update Posted (Actual): May 11, 2017
• Last Update Submitted That Met QC Criteria: May 9, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Bioequivalence; Tinea pedis; Naftin
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Foot Diseases; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Skin Manifestations; Dermatomycoses; Foot Dermatoses; Pruritus; Tinea; Tinea Pedis; Anti-Infective Agents; Antifungal Agents; Naftifine
• Other Study ID Numbers: CD-13-661

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided