BE Study of Naftifine HCL

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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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