Atopic Dermatitis (AD)NEMOSKINNCT07730788
Reflectance Confocal Microscopy Evaluation of Skin Structure of Patients With Atopic Dermatitis Under Nemolizumab
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
- 11 Jun 2026to 11 Jun 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 patint with moderate to severe Atopic Dermatitis who require systemic treatment with nemolizumab
Who may be able to join
- Patients aged 18 years and older.
- Patients with moderate-to-severe Atopic Dermatitis who require systemic treatment with nemolizumab
- 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. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Drôme Nord
Romans-sur-Isère, Drôme, 26100
François Skowron, MD, 0475054680 ext. +33, f.skowron@ch-hdn.fr
Marina Bert, miss, +0475054698 ext. +33, m.bert@ch-hdn.fr
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. Nemolizumab is a a humanised anti-IL-31 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 nemolizumab.
- Conditions
- Atopic Dermatitis (AD), Atopic Dermatitis (Eczema)
- Keywords
- atopic dermatitis, reflectance confocal microscopy, nemolizumab
- 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: 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 posted28 Jul 2026
- Study start11 Jun 2026
- Primary completion11 Jun 2027 (estimated)
- Study completion11 Jun 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
- NCT07730788
- Sponsor's protocol ID
- 2026-A00585-46
- Acronym
- NEMOSKIN
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 28 Jul 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 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reflectance Confocal Microscopy Evaluation of Skin Structure of Patients With Atopic Dermatitis Under Nemolizumab
- ClinicalTrials.gov ID
- NCT07730788
- Acronym / sponsor ID
- NEMOSKIN / 2026-A00585-46
- Conditions
- Atopic Dermatitis (AD), Atopic Dermatitis (Eczema)
- Keywords
- atopic dermatitis, reflectance confocal microscopy, nemolizumab
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Hôpitaux Drôme NordUniversity, hospital or other
- Study start
- 11 Jun 2026 (actual)
- Primary completion
- 11 Jun 2027 (estimated)
- Study completion
- 11 Jun 2028 (estimated)
- First posted
- 28 Jul 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. Nemolizumab is a a humanised anti-IL-31 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 nemolizumab.
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 patint with moderate to severe Atopic Dermatitis who require systemic treatment with nemolizumab
Key inclusion criteria (5 listed)
- Patients aged 18 years and older.
- Patients with moderate-to-severe Atopic Dermatitis who require systemic treatment with nemolizumab
- 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: 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 28 Jul 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.
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: looking for participants now, as of the sponsor's last update on 28 Jul 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thickness of the atopic skin (time frame: 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 28 Jul 2026.