Safety and Efficacy of NAFT900 in Children With Tinea Capitis

Phase 2

Withdrawn

• Conditions: Tinea Capitis
• Interventions: Drug: Vehicle; Drug: Naftifine hydrochloride foam, 3%

• Registration Number: NCT02658292
• Lead Sponsor: Merz North America, Inc.

Brief 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

Study Timeline

• Study First Submitted: 2016-01-12
• Study First Submitted QC: 2016-01-14
• Study First Posted: 2016-01-18
• Primary Completion: 2016-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-08
• Last Update Posted: 2016-09-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Subjects with clinical diagnosis of tinea capitis with ≤15% involvement of the scalp.
2. Subjects with positive KOH microscopy and culture [for dermatophytes].
3. Male or female subjects ≥6 years and <13 years of age on the date of the Baseline Visit.

Exclusion Criteria

1. Subject with acute inflammatory fungal infection of the scalp (kerion)
2. 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).
3. Subjects who received immunosuppressant therapy, cytostatic therapy or radiation therapy within 4 weeks prior to the baseline.
4. Subjects who received systemic corticosteroids and/or systemic antibiotics within 4 weeks prior to study entry (or during study).
5. Subjects who have used systemic antifungal treatment within 4 weeks prior to the baseline.
6. 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.
7. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle	Vehicle Foam
NAFT900	Naftifine hydrochloride foam, 3%	NAFT900 (Naftifine hydrochloride foam, 3%)

Primary Outcome Measures

Name	Time	Method
Compare the proportion of subjects with complete cure	8 weeks	Complete cure defined as negative KOH microscopy, negative dermatophyte culture and a score of 0 on baseline signs

Secondary Outcome Measures

Name	Time	Method
Compare the proportion of subjects with an effective treatment	8 weeks	Effective treatment is defined as negative KOH microscopy, negative dermatophyte culture and a score of 0 or 1 on baseline signs
Compare the proportion of subjects with mycological cure	8 weeks	Mycological cure is defined as complete cure defined as negative KOH microscopy and negative dermatophyte culture