Tinea Pedis
Conditions
Keywords
Bioequivalence, Tinea pedis, Naftin
Brief summary
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).
Interventions
DRUGNaftifine hydrochloride 2%
Topical application for two weeks
DRUGPlacebo
Topical application for two weeks
DRUGNaftin® 2% (Naftifine hydrochloride 2%)
Topical application for two weeks
Sponsors
Genzum Life Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mycological cure and clinical cure for a single target lesion for Trichyphyton rubrum | week 6 + 4 days | After 6 weeks the skin scrapping will be collected for culture to find out the growth of T rubrum. Absence of growth suggests complete cure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mycological cure and clinical cure for Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum | week 6 + 4 days | After 6 weeks the skin scrapping will be collected for culture to find out the growth of T rubrum, T Mentagrophytes or E floccosum. Absence of growth suggests complete cure. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assessment of AEs for each treatment groups | week 6 + 4 days | number of adverse events reported will be collated from all the treatment arms, to evaluate the safety of the study drugs. |
Countries
Dominican Republic, United States
Outcome results
None listed