Safety and Efficacy of NAFT900 in Children With Tinea Capitis

NCT ID: NCT02658292

Last Updated: 2016-09-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL

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

Conditions

Tinea Capitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

NAFT900

NAFT900 (Naftifine hydrochloride foam, 3%)

Group Type: ACTIVE_COMPARATOR

Naftifine hydrochloride foam, 3%

Intervention Type: DRUG

Apply NAFT900 foam twice daily to the affected area(s) plus half-inch around each affected area for 4 weeks

Vehicle

Vehicle Foam

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: DRUG

Apply vehicle foam twice daily to the affected area(s) plus half-inch around each affected area for 4 weeks

Interventions

Naftifine hydrochloride foam, 3%

Apply NAFT900 foam twice daily to the affected area(s) plus half-inch around each affected area for 4 weeks

Intervention Type: DRUG

Vehicle

Apply vehicle foam twice daily to the affected area(s) plus half-inch around each affected area for 4 weeks

Intervention Type: DRUG

Other Intervention Names

NAFT900; Vehicle Foam

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merz North America, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Kuligowski, MD

Role: STUDY_DIRECTOR

Merz North America, Inc.

Other Identifiers

M902001001

Identifier Type: -

Identifier Source: org_study_id