BE Study of Naftifine HCL

Tinea Pedis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02633813
• Other study ID #: CD-13-661
• Status: Completed
• Phase: Phase 3
• First received: December 11, 2015
• Last updated: May 9, 2017
• Start date: March 2015
• Est. completion date: December 2015

Study information

• Verified date: May 2017
• Source: Genzum Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 693
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tinea
• Tinea Pedis

Intervention

Drug:
• Naftifine hydrochloride 2%
Topical application for two weeks
• Placebo
Topical application for two weeks
• Naftin® 2% (Naftifine hydrochloride 2%)
Topical application for two weeks

Locations

Country	Name	City	State
Dominican Republic	Instituto Dermatológico	Barrio Maria Auxiliadora	Santo Domingo
Dominican Republic	Instituto Dermatológico y Cirugía de Piel	Santo Domingo	San Cristóbal
United States	Bellaire Dermatology Associates	Bellaire	Texas
United States	Moore Clinical Research Inc	Brandon	Florida
United States	Research Across America	Dallas	Texas
United States	Family Practise	Mesquite	Texas
United States	FXM Research Corp	Miami	Florida
United States	International Dermatology Research, Inc,	Miami	Florida
United States	Savin Medical Group Research	Miami	Florida
United States	FXM Research Miramar	Miramar	Florida
United States	Research Across America	Plano	Texas
United States	Medi Search	Saint Joseph	Missouri
United States	North Tampa MOORE Clinical Research, Inc.	Tampa	Florida
United States	South Tampa, MOORE Clinical Research, Inc.	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Genzum Life Sciences

Countries where clinical trial is conducted

United States,  Dominican Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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