A Phase 4 interventional study of Dupilumab in Atopic Dermatitis and Atopic Dermatitis Eczema, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-09.
Sponsored by University of California, San Francisco · Phase 4, Interventional, and Treatment
This is a single-arm, open-label study, which will examine the effect of dupilumab on quality of life in atopic dermatitis patients.
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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 34 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Drug: Dupilumab
Dupilumab treatment
Also known as: Dupixent
Psychological General Well-Being Scale (PGWB)
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.
Time frame: 16 weeks
Work Productivity and Activity Impairment Scale (WPAI:SHP)
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. Scoring equations: 1. Percent work time missed due to problem: Q2/(Q2+Q4) 2. Percent impairment while working due to problem: Q5/10 3. Percent overall work impairment due to problem: Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4)))x(Q5/10)\] 4. Percent activity impairment due to problem: Q6/10
Time frame: 16 weeks
Dermatology Life Quality Index (DLQI)
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.
Time frame: 16 weeks
Itch Numerical Rating Scale
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.
Time frame: 16 weeks
Pain Numerical Rating Scale
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.
Time frame: 16 weeks
PSQI
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.
Time frame: 16 weeks
| Milestone | Dupilumab Treatment |
|---|---|
| Started | 34 |
| Completed | 24 |
| Not completed | 10 |
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.
| score on a scale | Dupilumab Treatment |
|---|---|
| Baseline | 68.3 ± 19.5 |
| Week 16 | 73.7 ± 23.7 |
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. Scoring equations: 1. Percent work time missed due to problem: Q2/(Q2+Q4) 2. Percent impairment while working due to problem: Q5/10 3. Percent overall work impairment due to problem: Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4)))x(Q5/10)\] 4. Percent activity impairment due to problem: Q6/10
| percentage of overall work impairment | Dupilumab Treatment |
|---|---|
| Baseline | 0.45 ± 0.26 |
| Week 16 | 0.24 ± 0.25 |
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.
| score on a scale | Dupilumab Treatment |
|---|---|
| Baseline | 16.4 ± 7.0 |
| Week 16 | 8.0 ± 6.8 |
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.
| score on a scale | Dupilumab Treatment |
|---|---|
| Baseline | 7.7 ± 2.0 |
| Week 16 | 3.5 ± 2.6 |
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.
| score on a scale | Dupilumab Treatment |
|---|---|
| Baseline | 5.3 ± 3.2 |
| Week 16 | 2.0 ± 2.3 |
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.
| score on a scale | Dupilumab Treatment |
|---|---|
| Baseline | 10.05 ± 4.58 |
| Week 16 | 6.59 ± 4.38 |
Collected over 52 Weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dupilumab Treatment | 0/34 (0%) | 0/34 (0%) | 3/34 (8.8%) |
| Event | Dupilumab Treatment |
|---|---|
| Facial erythemaSkin and subcutaneous tissue disorders | 1/34 |
| Eye rednessSkin and subcutaneous tissue disorders | 1/34 |
| Eyelid swellingSkin and subcutaneous tissue disorders | 1/34 |
| Age, Continuous(years) | Dupilumab Treatment |
|---|---|
| Mean | 40.1 ± 16.3 |
| Sex: Female, Male(Participants) | Dupilumab Treatment |
|---|---|
| Female | 12 |
| Male | 22 |
| Race (NIH/OMB)(Participants) | Dupilumab Treatment |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 17 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 12 |
| More than one race | 0 |
| Unknown or Not Reported | 3 |
| Region of Enrollment(participants) | Dupilumab Treatment |
|---|---|
| United States | 34 |
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University of California, San Francisco