Trial | NCT02633813  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    naftifine ...

  • Study Participants

    693
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 Started
Mar 31
2015
Primary Completion
Nov 30
2015
Study Completion
Dec 31
2015
Last Update
May 11
2017

Drug Naftifine hydrochloride 2%

Topical application for two weeks

  • Other names: Naftifine hcl

Drug Placebo

Topical application for two weeks

  • Other names: Vehicle cream

Drug Naftin® 2% (Naftifine hydrochloride 2%)

Topical application for two weeks

  • Other names: Naftifine hcl

Naftifine hydrochloride 2% Experimental

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.

Naftin® 2% (Naftifine hydrochloride 2%) Active Comparator

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.

Placebo vehicle cream. Placebo Comparator

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.

Criteria 

Inclusion Criteria:

Healthy males and females aged more than or equal to 18 years
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)
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:

Pregnant or lactating or planning to become pregnant during the study period
Use of antipruritics, including antihistamines, within 72 hours prior to entry into the study
Use of topical corticosteroid, antibiotics or antifungal therapy within 2 weeks prior to entry into the study
Use of systemic (e.g., oral or injectable) corticosteroid, antibiotics or antifungal therapy within 1 month prior to entry into the study
Use of oral terbinafine or itraconazole within 2 months prior to entry into the study
Use of immunosuppressive medication or radiation therapy within 3 months prior to entry into the study.
Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.
Presence of any other infection of the foot or other disease process that might confound the treatment evaluation
History of dermatophyte infections unresponsive to systemic or topical antifungal drugs
Known hypersensitivity to Naftifine Hydrochloride or to any component of the formulation
No Results Posted