Pediatric Subjects With Tinea Corporis

Phase 4

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Naftin Cream, 2%	Naftin Cream	Once Daily
Placebo Cream	Placebo Cream	Once Daily

Primary Outcome Measures

Name	Time	Method
Primary Efficacy	Day 21	Complete cure defined by negative KOH result and negative dermatophyte culture

Secondary Outcome Measures

Name	Time	Method
Secondary Efficacy	Day 21	Treatment Effectiveness defined as negative KOH, negative culture, and improved sign and symptoms.

Locations (19): Merz Investigative Site#507001
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Panama City, Panama
Merz Investigative Site#001279
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Cidra, Puerto Rico
Merz Investigative Site#001097
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Nashville, Tennessee, United States
Merz Investigative Site#001316
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Tucson, Arizona, United States
Merz Investigative Site#001312
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Miami, Florida, United States
Merz Investigative Site#180002
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San Cristobal, Dominican Republic
Merz Investigative Site# 180001
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Santo Domingo, Dominican Republic
Merz Investigative Site#001314
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Henderson, Nevada, United States
Merz Investigative Site#001311
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Miami, Florida, United States
Merz Investigative Site #001310
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Miramar, Florida, United States
Merz Investigative Site#001313
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Fremont, California, United States
Investigative Site# 0010320
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Encino, California, United States
Merz Investigative Site#001301
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San Diego, California, United States
Merz Investigative Site#001309
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Omaha, Nebraska, United States
Merz Investigative Site#001307
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Saint Joseph, Missouri, United States
Merz Investigative Site#001126
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Raleigh, North Carolina, United States
Investigative Site# 0010319
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Gresham, Oregon, United States
Merz Investigative Site#001293
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Winston Salem, North Carolina, United States
Merz Investigative Site#504001
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San Pedro Sula, Honduras