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
1 other identifier
interventional
N/A
0 countries
N/A
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
Trial Health
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2016
CompletedFirst Posted
Study publicly available on registry
January 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedSeptember 9, 2016
September 1, 2016
January 12, 2016
September 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Compare the proportion of subjects with an effective treatment
8 weeks
Compare the proportion of subjects with mycological cure
8 weeks
Study Arms (2)
NAFT900
ACTIVE COMPARATORNAFT900 (Naftifine hydrochloride foam, 3%)
Vehicle
PLACEBO COMPARATORVehicle Foam
Interventions
Apply NAFT900 foam twice daily to the affected area(s) plus half-inch around each affected area for 4 weeks
Apply vehicle foam twice daily to the affected area(s) plus half-inch around each affected area for 4 weeks
Eligibility Criteria
You may qualify if:
- Subjects with clinical diagnosis of tinea capitis with ≤15% involvement of the scalp.
- Subjects with positive KOH microscopy and culture \[for dermatophytes\].
- Male or female subjects ≥6 years and \<13 years of age on the date of the Baseline Visit.
You may not qualify if:
- Subject with acute inflammatory fungal infection of the scalp (kerion)
- 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).
- Subjects who received immunosuppressant therapy, cytostatic therapy or radiation therapy within 4 weeks prior to the baseline.
- Subjects who received systemic corticosteroids and/or systemic antibiotics within 4 weeks prior to study entry (or during study).
- Subjects who have used systemic antifungal treatment within 4 weeks prior to the baseline.
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michael Kuligowski, MD
Merz North America, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2016
First Posted
January 18, 2016
Primary Completion
July 1, 2016
Last Updated
September 9, 2016
Record last verified: 2016-09