Atopic Dermatitis (AD)ADUTERCoMNCT07568665
Evaluation by Confocal Reflectance Microscopy of the Skin Structure of Patients With Atopic Dermatitis Treated With Tralokinumab Biotherapy.
An observational study of Atopic Dermatitis (AD) and Atopic Dermatitis (Eczema), run by Hôpitaux Drôme Nord at 1 site in France.
Trial summary
Atopic dermatitis (AD) is a chronic inflammatory skin disease with pruritus and recurrence of eczematous eruptions. Evaluation of response to treatment are only clinical using Eczema Area Severity Index (EASI), SCOring of Atopic Dermatitis Index (SCORAD) scores, with a risk of intra-observer variations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis (AD), Atopic Dermatitis (Eczema)
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 27 Nov 2025to 1 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with moderate-to-severe Atopic Dermatitis who require systemic treatment with tralokinumab
Who may be able to join
- Patients aged 18 years and older.
- Patients with moderate-to-severe Atopic Dermatitis who require systemic treatment with tralokinumab in the investigator's opinion.
- Patients affiliated with or entitled to a social security scheme.
- Patients capable of giving informed consent.
- Patients who have received informed information about the study and have co-signed an informed consent form for participation in the study, along with the investigator.
Who cannot join
- Patients who refuse to participate in the study and legally incapacitated adults
- Patients with an uncontrolled chronic disease that may require corticosteroid courses/treatment.
- Patients with a severe concomitant disease that, in the investigator's opinion, would negatively affect participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Atopic dermatitis (AD) is a chronic inflammatory skin disease with pruritus and recurrence of eczematous eruptions. Evaluation of response to treatment are only clinical using Eczema Area Severity Index (EASI), SCOring of Atopic Dermatitis Index (SCORAD) scores, with a risk of intra-observer variations. Tralokinumab is a fully human anti-IL-13 monoclonal antibody that has proven to be effective and well-tolerated for the treatment of patients with moderate-to-severe AD. Reflectance confocal microscopy (RCM) is a noninvasive procedure that allows to evaluate epidermis and papillary dermis at a cellular level. RCM allows skin structural and inflammatory parameters evaluation.
The aim of this study is to evaluate by RCM skin modifications of AD patients treated with tralokinumab.
- Conditions
- Atopic Dermatitis (AD), Atopic Dermatitis (Eczema)
- Keywords
- atopic dermatis, Reflectance Confocal Microscopy, tralokinumab
- Medical subject headings
- Dermatitis, Atopic, Eczema
What is being measured
The primary outcome is the main question the study is designed to answer.
Thickness of the atopic skin
µm, measured by Reflectance Confocal Microscopy (RCM)
Measured: • Before the initiation of treatment. • At Week 16.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start27 Nov 2025
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpitaux Drôme Nord
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568665
- Sponsor's protocol ID
- : 2025-A02067-42
- Acronym
- ADUTERCoM
- Status last verified
- Sep 2026
- First submitted
- 20 Mar 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data will be shared via Mendeley
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation by Confocal Reflectance Microscopy of the Skin Structure of Patients With Atopic Dermatitis Treated With Tralokinumab Biotherapy.
- ClinicalTrials.gov ID
- NCT07568665
- Acronym / sponsor ID
- ADUTERCoM / : 2025-A02067-42
- Conditions
- Atopic Dermatitis (AD), Atopic Dermatitis (Eczema)
- Keywords
- atopic dermatis, Reflectance Confocal Microscopy, tralokinumab
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Hôpitaux Drôme NordUniversity, hospital or other
- Study start
- 27 Nov 2025 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atopic dermatitis (AD) is a chronic inflammatory skin disease with pruritus and recurrence of eczematous eruptions. Evaluation of response to treatment are only clinical using Eczema Area Severity Index (EASI), SCOring of Atopic Dermatitis Index (SCORAD) scores, with a risk of intra-observer variations. Tralokinumab is a fully human anti-IL-13 monoclonal antibody that has proven to be effective and well-tolerated for the treatment of patients with moderate-to-severe AD. Reflectance confocal microscopy (RCM) is a noninvasive procedure that allows to evaluate epidermis and papillary dermis at a cellular level. RCM allows skin structural and inflammatory parameters evaluation.
The aim of this study is to evaluate by RCM skin modifications of AD patients treated with tralokinumab.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with moderate-to-severe Atopic Dermatitis who require systemic treatment with tralokinumab
Key inclusion criteria (5 listed)
- Patients aged 18 years and older.
- Patients with moderate-to-severe Atopic Dermatitis who require systemic treatment with tralokinumab in the investigator's opinion.
- Patients affiliated with or entitled to a social security scheme.
- Patients capable of giving informed consent.
- Patients who have received informed information about the study and have co-signed an informed consent form for participation in the study, along with the investigator.
Key exclusion criteria (3 listed)
- Patients who refuse to participate in the study and legally incapacitated adults
- Patients with an uncontrolled chronic disease that may require corticosteroid courses/treatment.
- Patients with a severe concomitant disease that, in the investigator's opinion, would negatively affect participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Thickness of the atopic skin
Time frame: • Before the initiation of treatment. • At Week 16.
µm, measured by Reflectance Confocal Microscopy (RCM)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Yes. data will be shared via Mendeley
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis (AD) and Atopic Dermatitis (Eczema), run by Hôpitaux Drôme Nord at 1 site in France.
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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. 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 France. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Thickness of the atopic skin (time frame: • Before the initiation of treatment. • At Week 16.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2026.