BE Study of Naftifine HCL

G

Genzum Life Sciences

Status and phase

Completed
Phase 3

Conditions

Tinea Pedis

Treatments

Drug: Placebo
Drug: Naftifine hydrochloride 2%
Drug: Naftin® 2% (Naftifine hydrochloride 2%)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02633813
CD-13-661

Details and patient eligibility

About

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).

Enrollment

693 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

693 participants in 3 patient groups, including a placebo group

Naftifine hydrochloride 2%
Experimental group
Description:
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.
Treatment:
Drug: Naftifine hydrochloride 2%
Naftin® 2% (Naftifine hydrochloride 2%)
Active Comparator group
Description:
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.
Treatment:
Drug: Naftin® 2% (Naftifine hydrochloride 2%)
Placebo vehicle cream.
Placebo Comparator group
Description:
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.
Treatment:
Drug: Placebo

Trial contacts and locations

14

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Data sourced from clinicaltrials.gov

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