Pediatric Subjects With Tinea Corporis

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

Tracking Information

• First Submitted Date: August 25, 2014
• First Posted Date: August 28, 2014
• Last Update Posted Date: October 28, 2016
• Study Start Date: August 2014
• Actual Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: 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: Pediatric Subjects With Tinea Corporis
• 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
• 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Tinea Corporis

Intervention

• Drug: Naftin Cream
• Drug: Placebo Cream

Study Arms

• Experimental: Naftin Cream, 2%
  Once Daily
  Intervention: Drug: Naftin Cream
• Placebo Comparator: Placebo Cream
  Once Daily
  Intervention: Drug: Placebo Cream

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 12, 2016): 230
• Original Estimated Enrollment (submitted: August 26, 2014): 318
• Actual Study Completion Date: December 2015
• Actual Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 2 Years to 17 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Dominican Republic, Honduras, Panama, Puerto Rico, United States

Administrative Information

• NCT Number: NCT02227290
• Other Study ID Numbers: MUS90200_4024_1
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Merz North America, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Merz North America, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Alan Fleischer, MD; Merz North America, Inc.

• PRS Account: Merz North America, Inc.
• Verification Date: October 2016