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Pediatric Subjects With Tinea Corporis

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ClinicalTrials.gov Identifier: NCT02227290
Recruitment Status : Completed
First Posted : August 28, 2014
Last Update Posted : October 28, 2016
Sponsor:
Information provided by (Responsible Party):
Merz North America, Inc.

Study Description
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Brief Summary:
The study is being done to see how well the study cream works when applied once a day to affected area of child (where they have ringworm). The results will be compared to those seen with a placebo cream which has no active ingredient. Safety of the cream will also be measured.

Condition or disease Intervention/treatment Phase
Tinea Corporis Drug: Naftin Cream Drug: Placebo Cream Phase 4

Detailed Description:
The objectives of this study are to evaluate the safety and efficacy of Naftin (naftifine hydrochloride) Cream, 2% applied once daily for 2 weeks, compared to its vehicle in the treatment of pediatric subjects aged 2 to 17 years and 11 months with positive potassium hydroxide (KOH), positive dermatophyte culture, and clinical signs and symptoms of tinea corporis.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 4, Double-Blind, Randomized, Vehicle-Controlled, Multicenter, Parallel Group Evaluation of the Efficacy and Safety of Naftin (Naftifine Hydrochloride) Cream, 2% in Pediatric Subjects With Tinea Corporis
Study Start Date : August 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinea Infections

Arms and Interventions
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Arm Intervention/treatment
Experimental: Naftin Cream, 2%
Once Daily
 Drug: Naftin Cream
Placebo Comparator: Placebo Cream
Once Daily
 Drug: Placebo Cream


Outcome Measures
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Primary Outcome Measures :
  1. Primary Efficacy [ Time Frame: Day 21 ]
    Complete cure defined by negative KOH result and negative dermatophyte culture


Secondary Outcome Measures :
  1. Secondary Efficacy [ Time Frame: Day 21 ]
    Treatment Effectiveness defined as negative KOH, negative culture, and improved sign and symptoms.


Other Outcome Measures:
  1. Clinical Success at Days 14 and 21 [ Time Frame: Day 14 and Day 21 ]
    Defined as sign and symptom scores of 0 or 1

  2. Clinical cure at Days 14 and 21 [ Time Frame: Days 14 and 21 ]
    Defined as erythema, induration, and pruritus score of 0.

  3. Subject Satisfaction [ Time Frame: Days 14 and 21 ]
    Assessment on 5 point scale or category of improvement from baseline.

  4. Complete Cure [ Time Frame: Day 14 ]
    Defined as negative mycology and abscence of signs/symptoms.

  5. Treatment of Effectiveness [ Time Frame: Day 14 ]
    Defined as negative KOH, negative culture, and signs/symptoms.

  6. Mycology Cure [ Time Frame: Day 14 ]
    Defined as negative KOH result and negative dermatophyte culture.


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males or non-pregnant females 2 years of age to 17 years, 11 months, of any race. Females of child bearing potential must have a negative urine pregnancy test.
  • Presence of tinea corporis by clinical evidence of a tinea infection of at least moderate erythema, moderate induration, and mild pruritus.
  • KOH positive and culture positive baseline skin scrapings obtained form the site with the mose severely affected lesion or a representative site of the overall severity.

Exclusion Criteria:

  • Tinea infection of the face, scalp, groin, and/or feet
  • A life-threatening condition in the opinion of the investigator (ex. autoimmune deficiency syndrome, cancer, etc) within the last 6 months.
  • Subjects with abnormal findings- physical or laboratory- that are considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of study results
  • Subjects with a known hypersensitivity or other contradictions to study medications or their components.
  • Subjects who have a recent history or who are currently known to abuse alcohol or drugs.
  • Uncontrolled diabetes mellitus.
  • Hemodialysis or chronic ambulatory peritoneal dialysis therapy.
  • Current diagnosis of immunocompromising conditions.
  • Current evidence of compromised skin, atopic or contact dermatitis, eczema, impetigo, lichen planus, pityriasis rosea, pityriasis versicolor, psoriasis, seborrhoeic dermatitis and syphilis.
  • Severe dermatophytoses, mucocutaneous candidiasis, or bacterial skin infection
  • Patients with tinea corporis who have concurrent dermatophytosis of the scalp, beard or nails.
Contacts and Locations
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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): NCT02227290


Locations
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Sponsors and Collaborators
Merz North America, Inc.
Investigators
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Study Director: Alan Fleischer, MD Merz North America, Inc.
More Information
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Responsible Party: Merz North America, Inc.
ClinicalTrials.gov Identifier: NCT02227290    
Other Study ID Numbers: MUS90200_4024_1
First Posted: August 28, 2014    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016
Keywords provided by Merz North America, Inc.:
Tinea Corporis
Ringworm
Additional relevant MeSH terms:
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Tinea
Dermatomycoses
Mycoses
Bacterial Infections and Mycoses
 Infections
Skin Diseases, Infectious
Skin Diseases