Clinical trial NCT02658292: Safety and Efficacy of NAFT900 in Children With Tinea Capitis
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Tinea Capitis
Keywords: fungus
antifungal
skin infection
hair infection
dermatophyte
scalp
skin
eyebrows
eyelashes
hair
Trichophyton
Microsporum
Endothrix
spores
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2016-01-18
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Compare the proportion of subjects with complete cure
timeFrame: 8 weeks
Secondary outcomes:
measure: Compare the proportion of subjects with an effective treatment
timeFrame: 8 weeks
measure: Compare the proportion of subjects with mycological cure
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merz North America, Inc.
name: Michael Kuligowski, MD
role: STUDY_DIRECTOR
References: