BE Study of Naftifine HCL

Completed · Phase 3 · Has a placebo group

Conditions studied: Tinea Pedis

In brief

The current study was randomized, double blind, placebo-controlled, prospective, multicenter, comparative therapeutic equivalence study. The study duration for each patient was 6 weeks: Following were the visit details. V1-Baseline and Randomization Visit (Day 1). V2- End of therapy visit (at the end of week 2 + 2 days). V3- Follow up visit (at the end of week 4 + 2 days). V4 - Test of cure visit ( at the end of week 6 + 4 days).

Key facts

Study ID

NCT02633813

Run by

Genzum Life Sciences

People needed

693

Starts

2015-03-01

Expected to finish

2015-12-01

Last updated by the study team

2017-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Healthy males and females aged more than or equal to 18 years
• 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 non-interdigital lesions should not be hyperkeratotic, i.e., characteristic of tinea pedis moccasin), and provisionally confirmed at baseline by a positive potassium hydroxide (KOH) wet mount preparation (i.e., skin scrapings from the target site are placed on a microscope slide with a drop of 10% KOH, and microscopic examination reveals segmented fungal hyphae)
• 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 (on a scale of 0-3, where 2 indicates moderate severity)

You may not qualify if…

• Pregnant or lactating or planning to become pregnant during the study period
• Use of antipruritics, including antihistamines, within 72 hours prior to entry into the study
• Use of topical corticosteroid, antibiotics or antifungal therapy within 2 weeks prior to entry into the study
• Use of systemic (e.g., oral or injectable) corticosteroid, antibiotics or antifungal therapy within 1 month prior to entry into the study
• Use of oral terbinafine or itraconazole within 2 months prior to entry into the study
• Use of immunosuppressive medication or radiation therapy within 3 months prior to entry into the study.
• Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.
• Presence of any other infection of the foot or other disease process that might confound the treatment evaluation
• History of dermatophyte infections unresponsive to systemic or topical antifungal drugs
• Known hypersensitivity to Naftifine Hydrochloride or to any component of the formulation

Where it is running

• Moore Clinical Research Inc — Brandon, Florida, United States
• Savin Medical Group Research — Miami, Florida, United States
• International Dermatology Research, Inc, — Miami, Florida, United States
• FXM Research Corp — Miami, Florida, United States
• FXM Research Miramar — Miramar, Florida, United States
• South Tampa, MOORE Clinical Research, Inc. — Tampa, Florida, United States
• North Tampa MOORE Clinical Research, Inc. — Tampa, Florida, United States
• Medi Search — Saint Joseph, Missouri, United States
• Bellaire Dermatology Associates — Bellaire, Texas, United States
• Research Across America — Dallas, Texas, United States
• Family Practise — Mesquite, Texas, United States
• Research Across America — Plano, Texas, United States
• Instituto Dermatológico y Cirugía de Piel — Santo Domingo, San Cristóbal, Dominican Republic
• Instituto Dermatológico — Barrio Maria Auxiliadora, Santo Domingo Province, Dominican Republic

Full record on ClinicalTrials.gov

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