Clinical trial NCT02633813: BE Study of Naftifine HCL
Official title: A Randomized, Prospective Multicenter, Double Blind, Parallel Assignment Placebo Controlled BE Study Of Naftifine Hydrochloride 2% Topical Cream With Naftin® In Patients With Tinea Pedis Using Clinical Endpoints
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tinea Pedis
Keywords: Bioequivalence
Tinea pedis
Naftin
Lead sponsor: Genzum Life Sciences
Sponsor class: INDUSTRY
First posted: 2015-12-17
Enrollment: 693
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Mycological cure and clinical cure for a single target lesion for Trichyphyton rubrum
timeFrame: week 6 + 4 days
Secondary outcomes:
measure: Mycological cure and clinical cure for Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum
timeFrame: week 6 + 4 days
Other outcomes:
measure: Assessment of AEs for each treatment groups
timeFrame: week 6 + 4 days
Locations:
city: Brandon
country: United States
facility: Moore Clinical Research Inc
state: Florida
city: Miami
country: United States
facility: Savin Medical Group Research
state: Florida
city: Miami
country: United States
facility: International Dermatology Research, Inc,
state: Florida
city: Miami
country: United States
facility: FXM Research Corp
state: Florida
city: Miramar
country: United States
facility: FXM Research Miramar
state: Florida
city: Tampa
country: United States
facility: South Tampa, MOORE Clinical Research, Inc.
state: Florida
city: Tampa
country: United States
facility: North Tampa MOORE Clinical Research, Inc.
state: Florida
city: Saint Joseph
country: United States
facility: Medi Search
state: Missouri
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates
state: Texas
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: Mesquite
country: United States
facility: Family Practise
state: Texas
city: Plano
country: United States
facility: Research Across America
state: Texas
city: Santo Domingo
country: Dominican Republic
facility: Instituto Dermatológico y Cirugía de Piel
state: San Cristóbal
city: Barrio Maria Auxiliadora
country: Dominican Republic
facility: Instituto Dermatológico
state: Santo Domingo
Study officials:
affiliation: Catawba Research
name: Zaidoon Al-Zubaidy
role: STUDY_CHAIR
References: