Safety and Efficacy of NAFT900 in Children With Tinea Capitis

• ClinicalTrials.gov Identifier: NCT02658292
• Recruitment Status: Withdrawn
• First Posted: January 18, 2016
• Last Update Posted: September 9, 2016
• Sponsor: Merz North America, Inc.
• Information provided by (Responsible Party): Merz North America, Inc.

Study Description

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

Condition or disease	Intervention/treatment	Phase
Tinea Capitis	Drug: Naftifine hydrochloride foam, 3%; Drug: Vehicle	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Primary Completion Date: July 2016

Arms and Interventions

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 Name: 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 Name: Vehicle Foam

Outcome Measures

Primary Outcome Measures :

1. Compare the proportion of subjects with complete cure [ Time Frame: 8 weeks ]
   Complete cure defined as negative KOH microscopy, negative dermatophyte culture and a score of 0 on baseline signs

Secondary Outcome Measures :

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

Eligibility Criteria

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

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.

Contacts and Locations

Sponsors and Collaborators

Merz North America, Inc.

Investigators

• Study Director: Michael Kuligowski, MD; Merz North America

More Information

• Responsible Party: Merz North America, Inc.
• ClinicalTrials.gov Identifier: NCT02658292
• Other Study ID Numbers: M902001001
• First Posted: January 18, 2016
• Last Update Posted: September 9, 2016
• Last Verified: September 2016

Keywords provided by Merz North America, Inc.:

fungus; antifungal; skin infection; hair infection; dermatophyte; scalp; skin; eyebrows; eyelashes; hair; Trichophyton; Microsporum; Endothrix; spores

Additional relevant MeSH terms:

Tinea; Tinea Capitis; Dermatomycoses; Skin Diseases, Infectious; Infection; Mycoses; Skin Diseases; Scalp Dermatoses; Naftifine; Antifungal Agents; Anti-Infective Agents