NCT02227290

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Merz North America, Inc. · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tinea Corporis

Interventions

Type	Name	Description
DRUG	Naftin Cream
DRUG	Placebo Cream

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-11-01
• Completion: 2015-12-01
• First posted: 2014-08-28
• Last updated: 2016-10-28

Locations

19 sites across 5 countries: United States, Dominican Republic, Honduras, Panama, Puerto Rico