BE Study of Naftifine HCL

Phase 3

Completed

• Conditions: Tinea Pedis
• Interventions: Drug: Naftin® 2% (Naftifine hydrochloride 2%); Drug: Placebo; Drug: Naftifine hydrochloride 2%

• Registration Number: NCT02633813
• Lead Sponsor: Genzum Life Sciences

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Study First Submitted: 2015-12-11
• Study First Submitted QC: 2015-12-16
• Study First Posted: 2015-12-17
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-09
• Last Update Posted: 2017-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 693

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naftin® 2% (Naftifine hydrochloride 2%)	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.
Placebo vehicle cream.	Placebo	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.
Naftifine hydrochloride 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.

Primary Outcome Measures

Name	Time	Method
Mycological cure and clinical cure for a single target lesion for Trichyphyton rubrum	week 6 + 4 days	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.

Secondary Outcome Measures

Name	Time	Method
Mycological cure and clinical cure for Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum	week 6 + 4 days	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.

Trial Locations

Locations (13)

Instituto Dermatológico y Cirugía de Piel; 🇩🇴 Santo Domingo, San Cristóbal, Dominican Republic

Moore Clinical Research Inc; 🇺🇸 Brandon, Florida, United States

Medi Search; 🇺🇸 Saint Joseph, Missouri, United States

South Tampa, MOORE Clinical Research, Inc.; 🇺🇸 Tampa, Florida, United States

Bellaire Dermatology Associates; 🇺🇸 Bellaire, Texas, United States

Family Practise; 🇺🇸 Mesquite, Texas, United States

Savin Medical Group Research; 🇺🇸 Miami, Florida, United States

FXM Research Miramar; 🇺🇸 Miramar, Florida, United States

Research Across America; 🇺🇸 Plano, Texas, United States

International Dermatology Research, Inc,; 🇺🇸 Miami, Florida, United States

North Tampa MOORE Clinical Research, Inc.; 🇺🇸 Tampa, Florida, United States

Instituto Dermatológico; 🇩🇴 Barrio Maria Auxiliadora, Santo Domingo, Dominican Republic

FXM Research Corp; 🇺🇸 Miami, Florida, United States