NCT03826901

Delgocitinib Cream for the Treatment of Moderate to Severe Atopic Dermatitis During 8 Weeks in Adults, Adolescents, and Children

A Phase 1 Open-label, Multi-centre, Single-arm Trial to Evaluate the Safety and Pharmacokinetics (Including MUsT) of Twice Daily Topical Application of Delgocitinib Cream for 8 Weeks in Adults, Adolescents, and Children With Moderate to Severe Atopic Dermatitis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, open-label trial to evaluate safety and pharmacokinetics of topical delgocitinib cream applied to pediatric subjects (2-17 years) and adult subjects (18 years and above) with atopic dermatitis.

Detailed description

A phase 1 open-label, multi-centre, single-arm trial to evaluate the safety and pharmacokinetics (including MUsT) of twice daily topical application of delgocitinib cream for 8 weeks in adults, adolescents, and children with moderate to severe atopic dermatitis

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	delgocitinib	Cream for topical application

Timeline

• Start date: 2019-02-20
• Primary completion: 2021-10-29
• Completion: 2021-10-29
• First posted: 2019-02-01
• Last updated: 2025-02-24

Locations

16 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study