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

  • STATUS
    Recruiting
  • End date
    Dec 26, 2021
  • participants needed
    30
  • sponsor
    University of California, San Francisco
Updated on 26 January 2021
atopy
eczema
phototherapy
dupilumab

Summary

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

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.

Details
Condition Eczema, ATOPIC DERMATITIS, Dermatitis, Eczema (Atopic Dermatitis), Dermatitis, Atopic, Hand Dermatitis, Eczema (Atopic Dermatitis - Pediatric), Atopic Dermatitis Eczema, Eczéma (Dermatite Atopique), Dermatite Atopique, atopic dermatitis/eczema
Treatment Dupilumab
Clinical Study IdentifierNCT03667014
SponsorUniversity of California, San Francisco
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Ability to provide written informed consent and comply with the protocol
At least 18 years of age
Diagnosis of atopic dermatitis at least 6 months prior to enrollment, having stable (unchanged) disease for at least 2 months
Non-immune-compromised status
Subjects have moderate-to-severe atopic dermatitis, classified as Eczema Area and Severity Index (EASI) score greater than or equal to 6
Subject is considered a candidate for phototherapy or systemic therapy
Subjects of child-bearing potential must have a negative urine pregnancy test within 7 days prior to first dose of dupilumab
Sexually active subjects of childbearing potential must agree to use medically acceptable form of contraception during screening and throughout the study
Subject meets concomitant medication requirements (see below)

Exclusion Criteria

Younger than 18 years of age
Has mild atopic dermatitis, classified as EASI score less than 6
History of known or suspected intolerance to any of the ingredients of the investigational study product
Evidence of skin conditions other than atopic dermatitis that would interfere with study-related evaluations of atopic dermatitis
History of immune-compromised status [e.g. human immunodeficiency virus (HIV) positive status or other immune suppressing drug] or a congenital or acquired immunodeficiency or subject testing positive for HIV during screening procedures
Has a poorly controlled medical condition including, but not limited to, unstable cardiovascular disease, poorly controlled diabetes, recent stroke, history of recurrent infections, or any other condition for which, in the opinion of the investigator, participation in the study would place the subject at risk
Has a history of or ongoing drug or alcohol abuse
Is not willing to comply with concomitant medication requirements
Is known, or suspected of being unable to comply with the study protocol
Subjects who are well controlled on current treatment for atopic dermatitis and participation in the study may worsen disease control significantly
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