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Atopic DermatitisPhase 4BALISTAD-CNNCT05624112

Dupilumab Skin BArrier Function and LIpidomics STudy in Atopic Dermatitis in China

A Phase 4 study testing Dupilumab in people with Atopic Dermatitis and Dermatitis Atopic, run by Sanofi at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Atopic Dermatitis, Dermatitis Atopic
What is being tested?
Dupilumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteChina
Study dates
25 Nov 2022to 25 Jan 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Dermatology Hospital of Southern Medical University (Guangdong Provincial Dermatology Hospital)

    Guangzhou, Guangdong, 510091

Other trials in China

About this study

Official title: Open-label Exploratory Study to Evaluate the Effect of Dupilumab on Skin Barrier Function in Chinese Patients With Moderate to Severe Atopic Dermatitis

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.

Being tested
Dupilumab
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DupilumabDrug

    Also called Dupixent

    Dupilumab solution in a pre-filled syringe for Subcutaneous injection

Study groups in NCT05624112
Study groupRoleWhat they receive
AD patientsExperimentalAD patients aged ≥12 and ≤ 65
Receives: Drug: Dupilumab
Healthy volunteersNo interventionNon-treatment healthy volunteers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent change from baseline in TEWL after 5 skin tape stripping (STS) assessed on lesional skin at Week16 in AD patients.

    Measured: From baseline to week16

Secondary outcomes (1)

  1. Change from baseline in TEWL before and after 10, 15 and 20 STS respectively assessed on lesional skin at Week16 in AD patients

    Measured: From baseline to week16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2022
  2. Study start25 Nov 2022
  3. Primary completion25 Jan 2024
  4. Study completion25 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05624112
Sponsor's protocol ID
LPS17250
Other IDs
U1111-1272-6687
Acronym
BALISTAD-CN
Status last verified
Sep 2025
First submitted
13 Nov 2022
Last updated
15 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

  • Liu T, Chen S, Zhao W, Di D, Liu J, Tian Y, Luo Y, Xu Y, Xue R, Ye L, Pei X, Yu B, Wang Y, Zhang J, Yu X, Wen W, Yuan L, Ji S, Hu C, Shen D, Guo Y, Liang Y. Impact of Dupilumab Therapy on Skin Barrier Function in Patients With Moderate-to-Severe Atopic Dermatitis: A Phase IV, Non-Randomized, Open-Label, Parallel-Group Clinical Study. MedComm (2020). 2026 Oct 25;7(11):e71091. doi: 10.1002/mco2.71091. eCollection 2026 Nov.

    PubMed 42928785

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dupilumab in people with Atopic Dermatitis and Dermatitis Atopic, run by Sanofi at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change from baseline in TEWL after 5 skin tape stripping (STS) assessed on lesional skin at Week16 in AD patients. (time frame: From baseline to week16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05624112, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.

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