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

Taro Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Tinea Pedis

Treatments: Drug: Naftifine Hydrochloride Gel 2%; Drug: Naftin® Gel 2%; Drug: Placebo Topical Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02335255

NFTC 1409-1722

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,519 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,519 participants in 3 patient groups, including a placebo group

Naftifine Hydrochloride Gel 2%

Experimental group

Description:

Naftifine Hydrochloride Gel 2% (Taro Pharmaceuticals Inc.)

Treatment:

Drug: Naftifine Hydrochloride Gel 2%

Naftin® Gel 2%

Active Comparator group

Description:

Naftin® (Naftifine Hydrochloride) Gel 2% (Merz Pharmaceuticals, LLC)

Treatment:

Drug: Naftin® Gel 2%

Placebo Topical Gel

Placebo Comparator group

Description:

Placebo Topical Gel (Taro Pharmaceuticals Inc.)

Treatment:

Drug: Placebo Topical Gel