Dupixent shows promise for eczema skin barrier in chinese patients
NCT ID NCT05624112
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested the drug dupilumab (Dupixent) in 44 Chinese patients aged 12 to 65 with moderate to severe atopic dermatitis (eczema). The goal was to see if the drug improves skin barrier function by measuring water loss through the skin over 16 weeks. Participants received dupilumab injections and had regular skin tests. The study is complete, but results are not yet published.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dupilumab (Dupixent)
- What this could lead to
- If successful, this could confirm that dupilumab improves skin barrier function, supporting its use for managing atopic dermatitis.
- What could go wrong
- This is a small, open-label study with no placebo group, so results may not be definitive. It only looks at a specific measure (water loss) and may not reflect overall symptom improvement.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
44 people
The number who actually took part.
- Started
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Nov 2022
- Finished
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Jan 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
12 to 65 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 that are eligible to be treated with dupilumab according to package insert. * Patients with AD must have active lesions on the upper limbs or lower limbs, with severity for lesion erythema or edema/papulation ≥2 at screening on the 0-3 scale of the ISS. * Participants should have a non-lesional (normal looking) skin area 4 cm from the edge of the lesional area. If unable to identify non-lesional skin 4 cm from the lesional area, it is acceptable to identify normal looking skin as close to the lesion as possible. HEALTHY VOLUNTEERS ONLY: * Age and gender matched to a selected AD patient by study site. Adolescents aged 12 to 17 years will be matched by post puberty status, and adults aged 18 to 65 years will be matched by age as close as possible within 10 years of age. * No current or prior dermatologic or systemic condition that could interfere with the assessments. Exclusion Criteria: * Medical conditions * Previous treatment with dupilumab within 6 months prior to screening. * Skin conditions other than AD that can confound assessments in the area of TEWL assessments in the opinion of the investigator (ie, skin atrophy, ichthyosis, Netherton syndrome, severe photo damage). * Cracked, crusted, oozing, or bleeding AD lesions in the designated lesional assessment area leaving insufficient skin that is adequate for TEWL assessments. * Ocular disorder that in the opinion of the investigator could adversely affect the individual's risk for study participation. Examples include -but are not limited to- individuals with a history of active cases of herpes keratitis; Sjogren's syndrome, keratoconjunctivitis sicca or dry eye syndrome that require daily use of supplemental lubrication; or individuals with ocular conditions that require the use of ocular corticosteroids or cyclosporine. * Systemic AD treatment or phototherapy within 4 weeks of baseline. * Topical AD treatment within 1 week of baseline. Face and neck may be treated with topical steroids during the washout period if approved by the investigator. * Severe prior or concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's participation in the study. Examples include, but are not limited to patients with short life expectancy, patients with uncontrolled diabetes (hemoglobin A1c ≥9%), patients with cardiovascular conditions (eg, Class III or IV cardiac failure according to the New York Heart Association classification), severe renal conditions (eg, patients on dialysis), hepato-biliary conditions (eg, Child-Pugh class B or C), neurological conditions (eg, demyelinating diseases), active major autoimmune diseases (eg, lupus, inflammatory bowel disease, rheumatoid arthritis, etc), other severe endocrinological, gastrointestinal, metabolic, pulmonary, psychiatric (known suicidal intentions),lymphatic diseases, or any illness(es) that resulted in prior or current use of chemotherapy or radiation . The specific justification for patients excluded under this criterion will be noted in study documents (chart notes, electronic case report forms \[eCRF\], screening logs, etc). * History of hypersensitivity reaction to tape or adhesives. Prior/concomitant therapy * Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known) prior to Day 1, whichever is longer. * Treatment with live (attenuated) vaccine within 4 weeks before the baseline visit. Prior/concurrent clinical study experience * Current participation in another investigational clinical study. Other exclusions * Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized * Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures * Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals (in conjunction with section 1.61 of the ICH-GCP Ordinance E6) * Any specific situation during study implementation/course that may raise ethics considerations * Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study * Planned or anticipated major surgical procedure during the patient's participation in this study. * Pregnant or breast-feeding women or were planning to become pregnant or breastfeed during the subject's participation in this study. * Women unwilling to use adequate birth control, if of reproductive potential and sexually active. * Healthy volunteers with a personal history of an atopic condition. * Healthy volunteers with use of any topical treatment anywhere except Cetaphil, Vanicream, or the preferred moisturizer not containing additives on non-targeted skin areas.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Dermatology Hospital of Southern Medical University (Guangdong Provincial Dermatology Hospital)
Guangzhou, Guangdong, 510091, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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