BE Study of Naftifine HCL
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Naftifine hydrochloride 2% A thin layer of sufficient quantity of Naftifine hydrochloride cream need to be applied to the affected areas plus an approximate ½ inch margin of healthy surrounding skin once daily consecutively for 2 weeks. |
Drug: Naftifine hydrochloride 2%
Topical application for two weeks
Other Names:
|
| Active Comparator: Naftin® 2% (Naftifine hydrochloride 2%) A thin layer of sufficient quantity of Naftifine hydrochloride cream need to be applied to the affected areas plus an approximate ½ inch margin of healthy surrounding skin once daily consecutively for 2 weeks. |
Drug: Naftin® 2% (Naftifine hydrochloride 2%)
Topical application for two weeks
Other Names:
|
| Placebo Comparator: Placebo vehicle cream. A thin layer of sufficient quantity of vehicle cream need to be applied to the affected areas plus an approximate ½ inch margin of healthy surrounding skin once daily consecutively for 2 weeks. |
Drug: Placebo
Topical application for two weeks
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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)
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Moore Clinical Research Inc | Brandon | Florida | United States | 33511 |
| 2 | Savin Medical Group Research | Miami | Florida | United States | 33014 |
| 3 | International Dermatology Research, Inc, | Miami | Florida | United States | 33144 |
| 4 | FXM Research Corp | Miami | Florida | United States | 33175 |
| 5 | FXM Research Miramar | Miramar | Florida | United States | 33027 |
| 6 | South Tampa, MOORE Clinical Research, Inc. | Tampa | Florida | United States | 33609 |
| 7 | North Tampa MOORE Clinical Research, Inc. | Tampa | Florida | United States | 33618 |
| 8 | Medi Search | Saint Joseph | Missouri | United States | 64506 |
| 9 | Bellaire Dermatology Associates | Bellaire | Texas | United States | 77401 |
| 10 | Research Across America | Dallas | Texas | United States | 75234 |
| 11 | Family Practise | Mesquite | Texas | United States | 75149 |
| 12 | Research Across America | Plano | Texas | United States | 75093 |
| 13 | Instituto Dermatológico y Cirugía de Piel | Santo Domingo | San Cristóbal | Dominican Republic | 91000 |
| 14 | Instituto Dermatológico | Barrio Maria Auxiliadora | Santo Domingo | Dominican Republic | 10305 |
Sponsors and Collaborators
- Genzum Life Sciences
Investigators
- Study Chair: Zaidoon Al-Zubaidy, Catawba Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CD-13-661