Dupilumab Skin BArrier Function and LIpidomics STudy in Atopic Dermatitis in China (NCT05624112) | Clinical Trial Compass
CompletedPhase 4
Dupilumab Skin BArrier Function and LIpidomics STudy in Atopic Dermatitis in China
China44 participantsStarted 2022-11-25
Plain-language summary
This is a 16-week, open label, exploratory study designed to investigate dupilumab's effect on skin barrier function as measured by transepidermal water loss (TEWL) before and after skin tape stripping. During the first 2 treatment weeks, patients will have 2 on-site visits/week, followed by one on-site visit/week up to Week 4, one on-site visit every two weeks from Week 4 to Week 8, and one on-site visit every 4 weeks up to Week 16 End of Treatment phase visit (EoT) thereafter.
A follow-up visit by phone 4 weeks after the last study assessment at Week 16 will end the study for each participant (End of Study: EoS). The maximum duration of the study per participant will be 24 weeks.
Who can participate
Age range
12 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant must be between 12 to 65 years of age (inclusive), at the time of signing the informed consent.
* Male or Female. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Willing to refrain from applying any topical medication products on the target assessment areas throughout the study until the EoT visit unless necessary to alleviate intolerable symptoms.
* Willing to refrain taking showers or soaking in a bathtub with soaps and body washes within 6 hours before TEWL assessments.
* Willing to NOT apply any moisturizers to the areas of the skin that are targeted assessment areas during the entire study from Day -7 to the EoT visit.
* Willing and able to comply with all clinic visits and study-related procedures.
* Capable of understanding and giving signed informed consent/assent as will be described in the protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. For adolescents ≥12 and \<18 years of age a specific ICF must also be signed by the participant's legally authorized representative.
ATOPIC DERMATITIS PAIENTS ONLY:
* Patients with AD diagnosis according to Hanifin and Rajka criteria at least 1 year before screening.
* Investigator Global Assessment (IGA) score of ≥3 at screening (on the 0-4 scale).
* Patients with moderate to severe atopic dermatitis…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent change from baseline in TEWL after 5 skin tape stripping (STS) assessed on lesional skin at Week16 in AD patients.