Safety and Efficacy of NAFT900 in Children With Tinea Capitis
Primary Purpose
Tinea Capitis
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Naftifine hydrochloride foam, 3%
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Tinea Capitis focused on measuring fungus, antifungal, skin infection, hair infection, dermatophyte, scalp, skin, eyebrows, eyelashes, hair, Trichophyton, Microsporum, Endothrix, spores
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
NAFT900
Vehicle
Arm Description
NAFT900 (Naftifine hydrochloride foam, 3%)
Vehicle Foam
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Compare the proportion of subjects with mycological cure
Mycological cure is defined as complete cure defined as negative KOH microscopy and negative dermatophyte culture
Full Information
NCT ID
NCT02658292
First Posted
January 12, 2016
Last Updated
September 8, 2016
Sponsor
Merz North America, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02658292
Brief Title
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
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merz North America, Inc.
4. Oversight
Data Monitoring Committee
No
5. 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinea Capitis
Keywords
fungus, antifungal, skin infection, hair infection, dermatophyte, scalp, skin, eyebrows, eyelashes, hair, Trichophyton, Microsporum, Endothrix, spores
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NAFT900
Arm Type
Active Comparator
Arm Description
NAFT900 (Naftifine hydrochloride foam, 3%)
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle Foam
Intervention Type
Drug
Intervention Name(s)
Naftifine hydrochloride foam, 3%
Other Intervention Name(s)
NAFT900
Intervention Description
Apply NAFT900 foam twice daily to the affected area(s) plus half-inch around each affected area for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Vehicle
Other Intervention Name(s)
Vehicle Foam
Intervention Description
Apply vehicle foam twice daily to the affected area(s) plus half-inch around each affected area for 4 weeks
Primary Outcome Measure Information:
Title
Compare the proportion of subjects with complete cure
Description
Complete cure defined as negative KOH microscopy, negative dermatophyte culture and a score of 0 on baseline signs
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Compare the proportion of subjects with an effective treatment
Description
Effective treatment is defined as negative KOH microscopy, negative dermatophyte culture and a score of 0 or 1 on baseline signs
Time Frame
8 weeks
Title
Compare the proportion of subjects with mycological cure
Description
Mycological cure is defined as complete cure defined as negative KOH microscopy and negative dermatophyte culture
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Kuligowski, MD
Organizational Affiliation
Merz North America, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of NAFT900 in Children With Tinea Capitis
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