NCT05456529

Study of Ruxolitinib Cream in Adolescents With Atopic Dermatitis

A Phase 3, Open-Label, One-Year Safety Study of Ruxolitinib Cream in Adolescents (Ages ≥ 12 Years to < 18 Years) With Atopic Dermatitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the long-term safety and tolerability of ruxolitinib cream in adolescents with Atopic Dermatitis (AD).

Detailed description

The study comprises of a 8 week continuous treatment period followed by 44 week Long Term Safety (LTS) period and 30 days safety follow up period. During Continuous treatment period all lesions identified at baseline will be treated and during LTS period only active lesions will be treated.

Conditions

• Atopic Dermatitis (AD)

Interventions

Type	Name	Description
DRUG	Ruxolitinib Cream	Ruxolitinib cream 1.5% twice daily (BID) during the continuous and LTS treatment period.

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-05-17
• Completion: 2024-05-17
• First posted: 2022-07-13
• Last updated: 2025-06-25
• Results posted: 2025-06-25

Locations

38 sites across 3 countries: United States, Canada, Poland

Regulatory

• FDA-regulated drug study