Pediatric Subjects With Tinea Corporis

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

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.

Study Overview

• Status: Completed
• Conditions: Tinea Corporis
• Intervention / Treatment: Drug: Placebo Cream; Drug: Naftin Cream

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
• Enrollment (Actual): 230
• Phase: Phase 4

Contacts and Locations

Study Locations

• Dominican Republic
  • San Cristobal, Dominican Republic
    • Merz Investigative Site#180002
  • Santo Domingo, Dominican Republic
    • Merz Investigative Site# 180001
• Honduras
  • San Pedro Sula, Honduras
    • Merz Investigative Site#504001
• Panama
  • Panama City, Panama
    • Merz Investigative Site#507001
• Puerto Rico
  • Cidra, Puerto Rico, 00739
    • Merz Investigative Site#001279
• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Merz Investigative Site#001316
  • California
    • Encino, California, United States, 91436
      • Investigative Site# 0010320
    • Fremont, California, United States, 94538
      • Merz Investigative Site#001313
    • San Diego, California, United States, 92102
      • Merz Investigative Site#001301
  • Florida
    • Miami, Florida, United States, 33144
      • Merz Investigative Site#001312
    • Miami, Florida, United States, 33175
      • Merz Investigative Site#001311
    • Miramar, Florida, United States, 33027
      • Merz Investigative Site #001310
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Merz Investigative Site#001307
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Merz Investigative Site#001309
  • Nevada
    • Henderson, Nevada, United States, 89074
      • Merz Investigative Site#001314
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Merz Investigative Site#001126
    • Winston Salem, North Carolina, United States, 27104
      • Merz Investigative Site#001293
  • Oregon
    • Gresham, Oregon, United States, 97030
      • Investigative Site# 0010319
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Merz Investigative Site#001097

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Naftin Cream, 2%; Once Daily	Drug: Naftin Cream
Placebo Comparator: Placebo Cream; Once Daily	Drug: Placebo Cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Efficacy	Complete cure defined by negative KOH result and negative dermatophyte culture	Day 21

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Efficacy	Treatment Effectiveness defined as negative KOH, negative culture, and improved sign and symptoms.	Day 21

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Success at Days 14 and 21	Defined as sign and symptom scores of 0 or 1	Day 14 and Day 21
Clinical cure at Days 14 and 21	Defined as erythema, induration, and pruritus score of 0.	Days 14 and 21
Subject Satisfaction	Assessment on 5 point scale or category of improvement from baseline.	Days 14 and 21
Complete Cure	Defined as negative mycology and abscence of signs/symptoms.	Day 14
Treatment of Effectiveness	Defined as negative KOH, negative culture, and signs/symptoms.	Day 14
Mycology Cure	Defined as negative KOH result and negative dermatophyte culture.	Day 14

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: August 25, 2014
• First Submitted That Met QC Criteria: August 26, 2014
• First Posted (Estimate): August 28, 2014

Study Record Updates

• Last Update Posted (Estimate): October 28, 2016
• Last Update Submitted That Met QC Criteria: October 27, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Tinea Corporis; Ringworm
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Dermatomycoses; Tinea
• Other Study ID Numbers: MUS90200_4024_1