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Safety and Efficacy of NAFT900 in Children With Tinea Capitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02658292
Recruitment Status : Withdrawn
First Posted : January 18, 2016
Last Update Posted : September 9, 2016
Sponsor:
Information provided by (Responsible Party):
Merz North America, Inc.

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinea Infections

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




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



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658292


Sponsors and Collaborators
Merz North America, Inc.
Investigators
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Study Director: Michael Kuligowski, MD Merz North America
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Responsible Party: Merz North America, Inc.
ClinicalTrials.gov Identifier: NCT02658292    
Other Study ID Numbers: M902001001
First Posted: January 18, 2016    Key Record Dates
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:
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Tinea
Tinea Capitis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Scalp Dermatoses
Naftifine
Antifungal Agents
Anti-Infective Agents