Pediatric Subjects With Tinea Corporis

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merz North America, Inc.; Merz Pharmaceuticals, LLC
• Treatments: Naftifine

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.