NCT02658292

Safety and Efficacy of NAFT900 in Children With Tinea Capitis

A Double-Blind, Randomized, Vehicle-Control, Multicenter Study to Evaluate the Efficacy and Safety of NAFT900 in Children With Tinea Capitis Aged 6 to < 13 Years

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Merz North America, Inc. · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

A Double-Blind, Randomized, Vehicle-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of NAFT-900 in Children Aged 6 to \< 13 Years with Tinea Capitis

Detailed description

This is an 8-week double-blind, randomized, vehicle-controlled, multicenter study of NAFT-900 compared to vehicle in the treatment of tinea capitis in children ≥6 years to \<13 years of age. There will be approximately 60 subjects enrolled. Qualifying subjects with clinical evidence of a tinea capitis infection involving ≤ 15% of the scalp, confirmed by positive culture, will be randomized 2:1 to one of the following treatments: * NAFT-900 (Naftifine hydrochloride foam, 3%) * Vehicle Foam The study will consist of up to 6 visits. Subjects will apply the assigned study product twice daily to the affected area(s) for 4 weeks

Conditions

• Tinea Capitis

Interventions

Type	Name	Description
DRUG	Naftifine hydrochloride foam, 3%	Apply NAFT900 foam twice daily to the affected area(s) plus half-inch around each affected area for 4 weeks
DRUG	Vehicle	Apply vehicle foam twice daily to the affected area(s) plus half-inch around each affected area for 4 weeks

Timeline

• Primary completion: 2016-07-01
• First posted: 2016-01-18
• Last updated: 2016-09-09