A Study to Evaluate the Quality of Life of Male and Female Adult Patients With Severe Refractory Atopic Dermatitis Treated With Dupilumab in Czech Republic
Study of Treatment Effects on Life Quality in Skin Condition
Study Overview
Assessment of the relationship between treatment response (EASI75) and change in quality of life (EQ-5D) by week 24.
Description of the:
- Change in disease activity after 16 and 24 weeks
- Change in subject and family quality of life after 16 and 24 weeks
- Change in sleep quality after 16 and 24 weeks
- Change in anxiety after 16 and 24 weeks
- Change in depression after 16 and 24 weeks
- Safety and tolerability
Study Details
28 weeks
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Atopic Dermatitis
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Age: 18 years or above
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Gender: All
Inclusion Criteria:
- Patient eligible for Dupixent therapy of AD according to the current SPC and reimbursement criteria given by the SUKL
- Signed informed consent
- 18 years and older (study questionnaires are validated for this age group). Patient is able to follow the prescribed regimen, routine follow-up visits and to fill the questionnaires
Exclusion Criteria:
- Patient not eligible for Dupixent therapy of AD according to the current SPC and reimbursement criteria given by the SUKL.
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
This study investigates the relationship between treatment response and changes in quality of life in patients with atopic dermatitis. Atopic dermatitis is a condition that causes the skin to become itchy, red, and swollen. The study measures how well patients respond to treatment and how it affects their day-to-day life, including their sleep and mental health.
Participants will be monitored for changes in disease activity, sleep quality, anxiety, and depression over 16 and 24 weeks. The study will also assess the safety and tolerability of the investigational medication. Participants will complete questionnaires to track these changes.
- Who can participate: Adults 18 years and older who are eligible for Dupixent therapy for atopic dermatitis and can attend follow-up visits are invited to participate.
- Study details: Participants will be asked to complete questionnaires about their quality of life, sleep, and mental health at various points during the study. They will also receive the investigational medication and attend routine follow-up visits. An inactive substance that looks like the investigational medicine may be used for comparison.
- Study Timelines: The study will last 28 weeks.
