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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Apply NAFT900 foam twice daily to the affected area(s) plus half-inch around each affected area for 4 weeks
Apply vehicle foam twice daily to the affected area(s) plus half-inch around each affected area for 4 weeks
Compare the proportion of subjects with complete cure
Complete cure defined as negative KOH microscopy, negative dermatophyte culture and a score of 0 on baseline signs
Time frame: 8 weeks
Compare the proportion of subjects with an effective treatment
Effective treatment is defined as negative KOH microscopy, negative dermatophyte culture and a score of 0 or 1 on baseline signs
Time frame: 8 weeks
Compare the proportion of subjects with mycological cure
Mycological cure is defined as complete cure defined as negative KOH microscopy and negative dermatophyte culture
Time frame: 8 weeks
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