NCT03415282

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

Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RVT-501 Topical Ointment in Pediatric Patients With Atopic Dermatitis

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Dermavant Sciences GmbH · Industry
• Sex: All
• Age: 2 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label Phase 1b study in pediatric patients age 2-11 years old with extensive atopic dermatitis.

Detailed description

The purpose of this multicenter, open-label study is to evaluate the safety, tolerability, and pharmacokinetics of RVT-501 0.5% topical ointment administered twice daily (BID) for 4 weeks in pediatric patients age 2-11 years of age with extensive atopic dermatitis. The efficacy of RVT-501 will also be evaluated as a secondary objective in these patients. The study will consist of three phases: Screening (up to 30 days), Treatment Phase (28 days), and Follow-up (7-10 days).

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	RVT-501 0.5% topical ointment	RVT-501 0.5% topical ointment twice daily (BID) for 4 weeks.

Timeline

• Start date: 2018-02-05
• Primary completion: 2018-07-24
• Completion: 2018-08-07
• First posted: 2018-01-30
• Last updated: 2018-05-11

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study