Safety and Efficacy of NAFT900 in Children With Tinea Capitis

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Tinea Capitis

Intervention / Treatment
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* Drug: Naftifine hydrochloride foam, 3%
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with clinical diagnosis of tinea capitis with ≤15% involvement of the scalp. Subjects with positive KOH microscopy and culture [for dermatophytes]. Male or female subjects ≥6 years and <13 years of age on the date of the Baseline Visit. Exclusion Criteria: Subject with acute inflammatory fungal infection of the scalp (kerion) Subjects with skin disease on the scalp, or any other condition or prior/present treatment which in the opinion of the investigator would interfere with the study drug's effect or assessments (e.g., psoriasis, seborrheic dermatitis). Subjects who received immunosuppressant therapy, cytostatic therapy or radiation therapy within 4 weeks prior to the baseline. Subjects who received systemic corticosteroids and/or systemic antibiotics within 4 weeks prior to study entry (or during study). Subjects who have used systemic antifungal treatment within 4 weeks prior to the baseline. Subjects who have used antifungal agents, corticosteroid preparations, ketoconazole, ciclopirox, salicylic acid, terbinafine, amorolfine, butenafine, clotrimazole, econazole, oxiconazole, sertaconazole, sulconazole, luliconazole, fluconazole, benzoic acid, griseofulvin, undecylenic acid, zinc pyrithione or selenium sulfide, or tar containing topical treatments for their scalp within 1 week prior to the baseline visit. Subjects with a life-threatening condition (ex. autoimmune deficiency syndrome, cancer, unstable angina, or myocardial infarction) within the last 6 months prior to baseline visit.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NAFT900<br>NAFT900 (Naftifine hydrochloride foam, 3%) | Drug: Naftifine hydrochloride foam, 3%<br>* Apply NAFT900 foam twice daily to the affected area(s) plus half-inch around each affected area for 4 weeks<br>* Other names: NAFT900;|
| Placebo Comparator: Vehicle<br>Vehicle Foam | Drug: Vehicle<br>* Apply vehicle foam twice daily to the affected area(s) plus half-inch around each affected area for 4 weeks<br>* Other names: Vehicle Foam;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fungus, antifungal, skin infection, hair infection, dermatophyte, scalp, skin, eyebrows, eyelashes, hair, Trichophyton, Microsporum, Endothrix, spores