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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
Information provided by (Responsible Party):
Merz North America, Inc.

Tracking Information
First Submitted Date  ICMJE August 25, 2014
First Posted Date  ICMJE August 28, 2014
Last Update Posted Date October 28, 2016
Study Start Date  ICMJE August 2014
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2014)
Primary Efficacy [ Time Frame: Day 21 ]
Complete cure defined by negative KOH result and negative dermatophyte culture
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2014)
Secondary Efficacy [ Time Frame: Day 21 ]
Treatment Effectiveness defined as negative KOH, negative culture, and improved sign and symptoms.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 26, 2014)
  • Clinical Success at Days 14 and 21 [ Time Frame: Day 14 and Day 21 ]
    Defined as sign and symptom scores of 0 or 1
  • Clinical cure at Days 14 and 21 [ Time Frame: Days 14 and 21 ]
    Defined as erythema, induration, and pruritus score of 0.
  • Subject Satisfaction [ Time Frame: Days 14 and 21 ]
    Assessment on 5 point scale or category of improvement from baseline.
  • Complete Cure [ Time Frame: Day 14 ]
    Defined as negative mycology and abscence of signs/symptoms.
  • Treatment of Effectiveness [ Time Frame: Day 14 ]
    Defined as negative KOH, negative culture, and signs/symptoms.
  • Mycology Cure [ Time Frame: Day 14 ]
    Defined as negative KOH result and negative dermatophyte culture.
Original Other Pre-specified Outcome Measures Same as current
Descriptive Information
Brief Title  ICMJE Pediatric Subjects With Tinea Corporis
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Tinea Corporis
Intervention  ICMJE
  • Drug: Naftin Cream
  • Drug: Placebo Cream
Study Arms  ICMJE
  • Experimental: Naftin Cream, 2%
    Once Daily
    Intervention: Drug: Naftin Cream
  • Placebo Comparator: Placebo Cream
    Once Daily
    Intervention: Drug: Placebo Cream
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 12, 2016)
Original Estimated Enrollment  ICMJE
 (submitted: August 26, 2014)
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Dominican Republic,   Honduras,   Panama,   Puerto Rico,   United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02227290
Other Study ID Numbers  ICMJE MUS90200_4024_1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Merz North America, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Merz North America, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Alan Fleischer, MD Merz North America, Inc.
PRS Account Merz North America, Inc.
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP