Evaluate the Safety and Efficacy of Naftifine Hydrochloride Cream 2% and Naftin® Cream 2% in Patients With Tinea Pedis

NCT02132260 | Completed Phase 1

• 1 other identifier: NFTC 1301
• Study Type: interventional
• Target: 890
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to compare the efficacy and safety of the test formulation of Naftifine Hydrochloride Cream 2% to Naftin® (Naftifine Hydrochloride) 2% Cream in a 6 week study in patients with tinea pedis.

Conditions

Tinea Pedis

Keywords

Naftifine; Naftin®; Tinea pedis

Outcome Measures

Primary Outcomes (1)

• Therapeutic Cure

  The proportion of subjects with therapeutic cure (both mycological cure and clinical cure) at the test-of-cure visit conducted four weeks after the end of treatment.

  6 weeks

Study Arms (3)

Naftifine Hydrochloride Cream 2%

EXPERIMENTAL

Naftifine Hydrochloride Cream 2% (Taro Pharmaceuticals Inc.)

Drug: Naftifine Hydrochloride Cream 2%

Naftin® Cream 2%

ACTIVE COMPARATOR

Naftin® (Naftifine Hydrochloride) Cream 2%

Drug: Naftin® (Naftifine Hydrochloride) Cream 2%

Placebo Topical Cream

PLACEBO COMPARATOR

Placebo Topical Cream

Drug: Placebo Topical Cream

Interventions

Naftifine Hydrochloride Cream 2% DRUG

Naftifine Hydrochloride Cream 2% (Taro Pharmaceuticals Inc.) applied once-daily for two weeks

Also known as: Naftifine

Naftifine Hydrochloride Cream 2%

Naftin® (Naftifine Hydrochloride) Cream 2% DRUG

Naftin® (Naftifine Hydrochloride) Cream 2% (Merz Pharmaceuticals, LLC) applied once-daily for two weeks.

Also known as: Naftifine

Naftin® Cream 2%

Placebo Topical Cream DRUG

Placebo Topical Cream (Taro Pharmaceuticals Inc.) applied once-daily for two weeks.

Also known as: vehicle

Placebo Topical Cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant, non-lactating females 18 years or older
• 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 presence of interdigital tinea pedis infection
• 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

You may not qualify if:

• 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 two weeks prior to baseline visit
• Use of systemic corticosteroids, antibiotics or antifungal therapies within one month prior to baseline visit
• Use of oral terbinafine or itraconazole within two months prior to baseline visit
• Use of immunosuppressive medication or radiation therapy within three 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 undue risk by participation or could jeopardize the integrity of study evaluations
• Evidence of any concurrent dermatophytic infection of the toe nails or dermatological condition of the foot that may interfere with tinea pedis evaluation
• Past history of dermatophyte infections with a lack of response ot antifungal therapy

Sponsors & Collaborators

• Sun Pharmaceutical Industries, Inc.: lead

MeSH Terms

Conditions

Tinea Pedis

Interventions

naftifine

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Foot Dermatoses; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pruritus; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Catawba Research

  http://catawbaresearch.com/contact/

  STUDY CHAIR

• Natalie Yantovskiy

  Taro Pharmaceuticals USA Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2014
• First Posted: May 7, 2014
• Study Start: August 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: March 1, 2014
• Last Updated: May 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share