NCT03394677

Study of RVT-501 Topical Ointment in Pediatric Patients With Atopic Dermatitis

Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerabililty of RVT-501 Topical Ointment in Pediatric Patients With Mild to Moderate Atopic Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Dermavant Sciences GmbH · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, vehicle controlled, double-blind Phase 2 study in pediatric patients age 2-17 years old with mild to moderate atopic dermatitis.

Detailed description

The purpose of this study is to evaluate the safety, efficacy, and tolerability of a 0.5% BID concentration of RVT-501 in pediatric patients 2-17 years of age with mild to moderate atopic dermatitis. The pharmacokinetics of RVT-501 will also be evaluated in patients 2-11 years of age.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	RVT-501 0.5% ointment	Patients will receive RVT-501 0.5% ointment twice daily (BID) for 4 weeks.
DRUG	Vehicle ointment	Placebo comparator - ointment twice daily (BID) for 4 weeks.

Timeline

• Start date: 2018-01-25
• Primary completion: 2018-07-02
• Completion: 2018-07-02
• First posted: 2018-01-09
• Last updated: 2018-07-19

Locations

7 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study