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

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

Study Overview

• Status: Withdrawn
• Conditions: Tinea Capitis
• Intervention / Treatment: Drug: Naftifine hydrochloride foam, 3%; Drug: Vehicle

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 Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Merz North America, Inc.
• Investigators: Study Director: Michael Kuligowski, MD, Merz North America, Inc.

Study record dates

Study Major Dates

• Primary Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: January 12, 2016
• First Submitted That Met QC Criteria: January 14, 2016
• First Posted (Estimate): January 18, 2016

Study Record Updates

• Last Update Posted (Estimate): September 9, 2016
• Last Update Submitted That Met QC Criteria: September 8, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: skin; antifungal; dermatophyte; hair; skin infection; eyelashes; fungus; scalp; hair infection; eyebrows; Trichophyton; Microsporum; Endothrix; spores
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Dermatomycoses; Scalp Dermatoses; Tinea; Tinea Capitis; Anti-Infective Agents; Antifungal Agents; Naftifine
• Other Study ID Numbers: M902001001