The Impact of Dupilumab on Quality of Life in Moderate to Severe Atopic Dermatitis Patients
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|ClinicalTrials.gov Identifier: NCT03667014|
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : November 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis Atopic Dermatitis Eczema||Drug: Dupilumab||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Impact of Dupilumab on Quality of Life in Moderate to Severe Atopic Dermatitis Patients|
|Actual Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: Dupilumab treatment
30 subjects will receive dupilumab for a treatment period of 52 weeks. All patients quality of life measures will be assessed with Psychological General Well-Being scale (PGWB), Work Productivity and Activity Impairment scale (WPAI), and Dermatology Life Quality Index (DLQI). Symptom and satisfaction will be assessed with Treatment Satisfaction Questionnaire for Medication (TSQM), Itch Numerical Rating Scale, Pain Numerical Rating Scale, and Pittsburgh Sleep Quality Assessment (PSQI).
Other Name: Dupixent
- Psychological General Well-Being scale (PGWB) [ Time Frame: 16 weeks ]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. It is a self-reported, 22 item questionnaire, scored 0-5 and summed. PGWB will be administered at every study visit.
- Work Productivity and Activity Impairment scale (WPAI:SHP) [ Time Frame: 16 weeks ]
Improvement in work productivity measured by change in Work Productivity and Activity Impairment scale (WPAI) at Week 16 from baseline. It measures the effect of health and symptom severity on work productivity and nonwork activities by assessing absenteeism, presenteeism, and impairment of daily activities. There are 6 questions, each with unique answers. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity.
- Percent work time missed due to problem: Q2/(Q2+Q4)
- Percent impairment while working due to problem: Q5/10
Percent overall work impairment due to problem:
- Percent activity impairment due to problem: Q6/10
- Dermatology Life Quality Index (DLQI) [ Time Frame: 16 weeks ]Improvement in quality of life measured by change in Dermatology Life Quality Index (DLQI) at Week 16 from baseline. It is a 10 item questionnaire with a final score calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
- Treatment Satisfaction Questionnaire for Medication (TSQM) [ Time Frame: 16 weeks ]Assessment of patient satisfaction with treatment measured by change in Treatment Satisfaction Questionnaire for Medication (TSQM) at Week 16 from baseline. TSQM is a 14-item questionnaire with 4 domains: effectiveness, convenience, global satisfaction, and side effects. Item scores are summed to give four domain scores, which are in turn transformed to a scale of 0-100, with higher scores indicating greater satisfaction.
- Itch Numerical Rating Scale [ Time Frame: 16 weeks ]Improvement in itch scores using numerical rating scales at Week 16 from baseline. This is a 0-10 scale with 0 equaling No itch, and 10 being Worst imaginable itch. Patients will circle number that describes the itch experienced from atopic dermatitis.
- Pain Numerical Rating Scale [ Time Frame: 16 weeks ]Improvement in pain scores using numerical rating scales at Week 16 from baseline. This is a 0-10 numerical scale with 10 as the worst imaginable itch. Patients circle the number that best describes the pain experienced from atopic dermatitis.
- PSQI [ Time Frame: 16 weeks ]Improvement in sleep quality measured by the Pittsburgh Sleep Quality Assessment (PSQI) at Week 16 from baseline. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03667014
|Contact: Quinn Thibodeaux, MDemail@example.com|
|Contact: Kristen Beck, MDfirstname.lastname@example.org|
|United States, California|
|UCSF Psoriasis and Skin Treatment Center||Recruiting|
|San Francisco, California, United States, 94118|
|Contact: Quinn Thibodeaux, MD 415-944-7618 email@example.com|
|Principal Investigator: Tina Bhutani, MD|
|Principal Investigator:||Tina Bhutani, MD||University of California, San Francisco|