BE Study of Naftifine HCL

Launched by GENZUM LIFE SCIENCES · Dec 16, 2015

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy males and females aged more than or equal to 18 years
• • 2. 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)
• • 3. 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)
• Exclusion Criteria:
• • 1. Pregnant or lactating or planning to become pregnant during the study period
• • 2. Use of antipruritics, including antihistamines, within 72 hours prior to entry into the study
• • 3. Use of topical corticosteroid, antibiotics or antifungal therapy within 2 weeks prior to entry into the study
• • 4. Use of systemic (e.g., oral or injectable) corticosteroid, antibiotics or antifungal therapy within 1 month prior to entry into the study
• • 5. Use of oral terbinafine or itraconazole within 2 months prior to entry into the study
• • 6. Use of immunosuppressive medication or radiation therapy within 3 months prior to entry into the study.
• • 7. Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.
• • 8. Presence of any other infection of the foot or other disease process that might confound the treatment evaluation
• • 9. History of dermatophyte infections unresponsive to systemic or topical antifungal drugs
• • 10. Known hypersensitivity to Naftifine Hydrochloride or to any component of the formulation