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

Taro Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Tinea Pedis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02132260

NFTC 1301

Details and patient eligibility

About

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.

Enrollment: 890 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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890 participants in 3 patient groups, including a placebo group

Naftifine Hydrochloride Cream 2%

Experimental group

Description:

Naftifine Hydrochloride Cream 2% (Taro Pharmaceuticals Inc.)

Treatment:

Drug: Naftifine Hydrochloride Cream 2%

Naftin® Cream 2%

Active Comparator group

Description:

Naftin® (Naftifine Hydrochloride) Cream 2%

Treatment:

Drug: Naftin® (Naftifine Hydrochloride) Cream 2%

Placebo Topical Cream

Placebo Comparator group

Description:

Placebo Topical Cream

Treatment:

Drug: Placebo Topical Cream