Evaluate Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® Gel 2% in Tinea Pedis

NCT ID: NCT02335255

Last Updated: 2018-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 1519 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-27
• Study Completion Date: 2018-05-15

Brief Summary

To compare the efficacy and safety of the test formulation Naftifine Hydrochloride Gel 2% to Naftin® (Naftifine Hydrochloride) Gel 2%

Detailed Description

The purpose of this study is to compare the efficacy and safety of the test formulation Naftifine Hydrochloride Gel 2% to Naftin® (Naftifine Hydrochloride) Gel 2% in a six week study (four weeks after the end of two week treatment) in patients with tinea pedis.

Conditions

Tinea Pedis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Naftifine Hydrochloride Gel 2%

Naftifine Hydrochloride Gel 2% (Taro Pharmaceuticals Inc.)

Group Type: EXPERIMENTAL

Naftifine Hydrochloride Gel 2%

Intervention Type: DRUG

Naftifine Hydrochloride Gel 2% applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin.

Naftin® Gel 2%

Naftin® (Naftifine Hydrochloride) Gel 2% (Merz Pharmaceuticals, LLC)

Group Type: ACTIVE_COMPARATOR

Naftin® Gel 2%

Intervention Type: DRUG

Naftin® Gel 2% applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin.

Placebo Topical Gel

Placebo Topical Gel (Taro Pharmaceuticals Inc.)

Group Type: PLACEBO_COMPARATOR

Placebo Topical Gel

Intervention Type: DRUG

Placebo Topical Gel applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin.

Interventions

Naftifine Hydrochloride Gel 2%

Naftifine Hydrochloride Gel 2% applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin.

Intervention Type: DRUG

Naftin® Gel 2%

Naftin® Gel 2% applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin.

Intervention Type: DRUG

Placebo Topical Gel

Placebo Topical Gel applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin.

Intervention Type: DRUG

Other Intervention Names

Naftifine; Naftifine; Vehicle

Eligibility Criteria

Inclusion Criteria

• Male or non-pregnant, non-lactating females 18 years of age or older.
• 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.
• Clinical diagnosis of interdigital tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot.
• The presence of interdigital tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic potassium hydroxide wet mount preparation.

Exclusion Criteria

• Females who are pregnant, lactating or planning to become pregnant during the study period.
• Use of antipruritics, including antihistamines within 72 hours prior to baseline visit.
• Use of topical corticosteroids, antibiotics or antifungal therapies within 2 weeks prior to baseline visit.
• Use of systemic corticosteroids, antibiotics or antifungal therapies within 1 month prior to baseline visit.
• Use of oral Terbinafine or Itraconazole within 2 months prior to baseline visit.
• Use of immunosuppressive medication or radiation therapy within 3 months prior to baseline visit.
• Any known hypersensitivity to Naftifine Hydrochloride, or any component of the formulation.
• Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.
• History of significant or current evidence of chronic infectious disease, system disorder, organ disorder, or other medical condition that would place patient at undue risk by participation or could jeopardize the integrity of the study evaluations.
• Evidence of any concurrent dermatophytic infection of the toe nails or dermatological condition of the foot that may interfere with the investigator's evaluation of tinea pedis.
• Patients with a past history of dermatophyte infections with a lack of response to antifungal therapy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Pharmaceutical Industries, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catawba Research

Role: STUDY_CHAIR

http://catawbaresearch.com/contact/

Other Identifiers

NFTC 1409-1722

Identifier Type: -

Identifier Source: org_study_id