NCT03667014

The Impact of Dupilumab on Quality of Life in Moderate to Severe Atopic Dermatitis Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label study, which will examine the effect of dupilumab on quality of life in atopic dermatitis patients.

Detailed description

This is a single center, open-label study, which will examine the effect of dupilumab on quality of life in atopic dermatitis (AD). Thirty patients with moderate to severe AD will receive dupilumab for a treatment period of 52 weeks (i.e. last injection on week 48). Improvement in patient quality of life after 52 weeks of treatment with dupilumab will be evaluated using validated dermatologic and non-dermatologic psychometric instruments. The primary endpoint is the improvement in quality of life measured by change in Psychological General Well-Being scale (PGWB) at Week 16 from baseline. Additionally, patients will be given a video recording device to document their experience with the study drug at home. Video footage of patient experiences will be compiled at the end of the study. The compiled video footage will subsequently be watched and analyzed to further understand the experiences of atopic dermatitis patients, and how undergoing dupilumab treatment alters these patients' experiences and attitudes with their skin disease.

Conditions

• Atopic Dermatitis
• Atopic Dermatitis Eczema

Interventions

Type	Name	Description
DRUG	Dupilumab	Dupilumab treatment

Timeline

• Start date: 2018-11-01
• Primary completion: 2022-12-15
• Completion: 2022-12-15
• First posted: 2018-09-12
• Last updated: 2024-01-09
• Results posted: 2024-01-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study