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

Tinea Pedis Clinical Trial

Official title:

A Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate the Safety and Efficacy of a Naftifine Hydrochloride Cream 2%and the Naftin® Cream 2% in Patients With Tinea Pedis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02132260
• Other study ID #: NFTC 1301
• Status: Completed
• Phase: Phase 1
• First received: May 5, 2014
• Last updated: May 4, 2017
• Start date: August 2013
• Est. completion date: March 2014

Study information

• Verified date: May 2017
• Source: Taro Pharmaceuticals USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 890
• Est. completion date: March 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tinea
• Tinea Pedis

Intervention

Drug:
• Naftifine Hydrochloride Cream 2%
Naftifine Hydrochloride Cream 2% (Taro Pharmaceuticals Inc.) applied once-daily for two weeks
• Naftin® (Naftifine Hydrochloride) Cream 2%
Naftin® (Naftifine Hydrochloride) Cream 2% (Merz Pharmaceuticals, LLC) applied once-daily for two weeks.
• Placebo Topical Cream
Placebo Topical Cream (Taro Pharmaceuticals Inc.) applied once-daily for two weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taro Pharmaceuticals USA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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