Pediatric Subjects With Tinea Corporis

Launched by MERZ NORTH AMERICA, INC. · Aug 26, 2014

Keywords

ClinConnect Summary

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.

Gender

ALL

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.