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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
230
Merz Investigative Site#001316
Tucson, Arizona, United States
Investigative Site# 0010320
Encino, California, United States
Primary Efficacy
Complete cure defined by negative KOH result and negative dermatophyte culture
Time frame: Day 21
Secondary Efficacy
Treatment Effectiveness defined as negative KOH, negative culture, and improved sign and symptoms.
Time frame: Day 21
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Merz Investigative Site#001313
Fremont, California, United States
Merz Investigative Site#001301
San Diego, California, United States
Merz Investigative Site#001312
Miami, Florida, United States
Merz Investigative Site#001311
Miami, Florida, United States
Merz Investigative Site #001310
Miramar, Florida, United States
Merz Investigative Site#001307
Saint Joseph, Missouri, United States
Merz Investigative Site#001309
Omaha, Nebraska, United States
Merz Investigative Site#001314
Henderson, Nevada, United States
...and 9 more locations