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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Withdrawn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
Merz North America, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

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

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

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

    First Posted
    January 12, 2016
    Last Updated
    September 8, 2016
    Sponsor
    Merz North America, Inc.
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    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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