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

Condition(s) targeted: Tinea Pedis

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

Phase: Phase 1

Status: Completed

Sponsored by: Taro Pharmaceuticals USA

Official(s) and/or principal investigator(s):
Natalie Yantovskiy, Study Director, Affiliation: Taro

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

Official title: A Multi-Center, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® (Naftifine Hydrochloride) Gel 2% in Patients With Tinea Pedis.

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Therapeutic cure after end of treatment

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.

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

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.

Starting date: June 2014
Last updated: January 29, 2015