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

Information source: Taro Pharmaceuticals USA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tinea Pedis

Intervention: Naftifine Hydrochloride Cream 2% (Drug); Naftin® (Naftifine Hydrochloride) Cream 2% (Drug); Placebo Topical Cream (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Taro Pharmaceuticals USA

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.

Clinical Details

Official title: A Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate the Safety and Efficacy of a Naftifine Hydrochloride Cream 2% (Taro Pharmaceuticals Inc.) and the Naftin (Naftifine Hydrochloride) Cream 2% (Merz Pharmaceuticals, LLC) in Patients With Tinea Pedis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Therapeutic Cure

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 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 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

Locations and Contacts

Additional Information

Starting date: August 2013
Last updated: May 5, 2014

Page last updated: August 23, 2015

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