Evaluate the Safety and Efficacy of Naftifine Hydrochloride Cream 2% and Naftin� Cream 2% in Patients With 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 Hydrochloride Cream 2% (Drug); Naftin® (Naftifine Hydrochloride) Cream 2% (Drug); Placebo Topical Cream (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Taro Pharmaceuticals USA
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.
Clinical Details
Official title: A Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate the Safety and Efficacy of a Naftifine Hydrochloride Cream 2% (Taro Pharmaceuticals Inc.) and the Naftin® (Naftifine Hydrochloride) Cream 2% (Merz Pharmaceuticals, LLC) in Patients With 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: August 2013
Last updated: May 5, 2014
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