DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital 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 HCl Cream 1% (Drug); Naftin® (Naftifine HCl) Cream 1% (Drug); Placebo topical cream (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Taro Pharmaceuticals USA


The objective of this study is to evaluate the efficacy and safety of the test formulation of Naftifine HCl Cream 1% (Taro Pharmaceuticals Inc.) as compared to the already marketed formulation Naftin® (Naftifine HCl) 1% Cream (Merz Pharmaceuticals) and placebo in patients with tinea pedis and to show the superiority of the active treatments over placebo when dosed once a day for 28 days.

Clinical Details

Official title: Randomized, Double-Blind, Placebo-Controlled, Multiple-Site, Parallel Design Study to Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital 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


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


Inclusion Criteria:

- Male or non-pregnant, non-lactating females 18 years of age or older.

- Signed informed consent form, which meets all criteria of current FDA regulations.

- If female and of child-bearing potential, have a negative urine pregnancy test at

baseline visit, and prepare to abstain from sexual intercourse or use a reliable method of contraception during the study.

- A total score of at least 4 for the clinical signs and symptoms of tinea pedis for

the target lesion. In addition, the most infected area must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for scaling.

- A confirmed 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 tinea pedis infection, confirmed by the observation of segmented

fungal hyphae during a microscopic 10% potassium hydroxide wet mount examination. Exclusion Criteria:

- Females who are pregnant, lactating or likely to become pregnant during the study.

- Use of antipruritics, including antihistamines within 72 hours prior to baseline


- 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 HCl, any component of the formulation or

other antifungal agents.

- Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.

- Significant history or current evidence of chronic infectious disease, system

disorder, organ disorder, or other medical condition that would place the 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 evaluation of tinea pedis.

- Patients with a past history of tinea pedis infections with a lack of response to

antifungal therapy.

- Patients who would be non-compliant with the requirements of the study protocol.

- Participation in a research study within 30 days prior to baseline visit.

- Employees or family members of employees of the research center or investigator.

- Previous participation in this study.

Locations and Contacts

Additional Information

Starting date: May 2012
Last updated: May 5, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017