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Atopic DermatitisFRAMENCT06837454

French Prospective Observational Study in Patients Eligible for Systemic Therapy for Atopic Dermatitis (AD)

An observational study of Atopic Dermatitis, run by Sanofi at 61 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The objective of the study is to describe the therapeutic management of patients more than or equal to 18 years old eligible for systemic therapy or treated by systemic therapy for atopic dermatitis (AD). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atopic Dermatitis
How many people
600 participants
Where
61 sitesFrance
Study dates
4 Feb 2025to 13 May 2027
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: Patients participating in this study will be more than equal to (≥) 18 years old, managed in France for moderate to severe AD, and who are either eligible to systemic treatment or currently under systemic treatment, in realworldsettings within the inclusion period.

Who may be able to join

  • Signed informed consent form.
  • Patient with moderate to severe AD according to the Investigator's judgment and
  • Patient eligible to systemic treatment as Atopic Dermatitis Control Tool (ADCT) more than or equal to (≥) 7 and/or use topical corticosteroids (TCS) more than (>) 90 gram (g)/month and/or TCS are not advisable.
  • or
  • Patient currently under systemic treatment.
  • Able to understand and complete study-related questionnaires.

Who cannot join

  • Any condition that, in the opinion of the Investigator, may interfere with patient's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other comorbidities that can predictably prevent the patient from adequately completing, as per routine care, the schedule of visits and assessments
  • Patient receiving systemic therapy only for a disease other than AD.
  • Patient participating in any interventional clinical trial at the time of enrolment.
  • Patient is under tutorship or curatorship; patient under safeguard of justice or deprived of his/her liberty by an administrative or court decision
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

61 sites in 1 country.

61 sites in 1 country

France61 sites
  • Investigational Site Number: 2500051

    Aix-en-Provence, 13100

  • Investigational Site Number: 2500023

    Amiens, 80000

  • Investigational Site Number: 2500004

    Angers, 49000

  • Investigational Site Number: 2500017

    Angers, 49100

  • Investigational Site Number: 2500050

    Arès, 33740

  • Investigational Site Number: 2500054

    Bayonne, 64100

  • Investigational Site Number: 2500043

    Bezannes, 51430

  • Investigational Site Number: 2500040

    Biarritz, 64200

  • Investigational Site Number: 2500036

    Bordeaux, 33000

  • Investigational Site Number: 2500053

    Bordeaux, 33000

  • Investigational Site Number: 2500061

    Boulogne-Billancourt, 92100

  • Investigational Site Number: 2500013

    Chalon-sur-Saône, 71100

  • Investigational Site Number: 2500026

    Chalon-sur-Saône, 71100

  • Investigational Site Number: 2500046

    Chalon-sur-Saône, 71100

  • Investigational Site Number: 2500041

    Châlons-en-Champagne, 51005

  • nvestigational Site Number: 2500018

    Cherbourg, 50102

  • Investigational Site Number: 2500020

    Cholet, 49300

  • Investigational Site Number : 2500048

    Clermont-Ferrand, 63100

  • Investigational Site Number: 2500059

    Contamine-sur-Arve, 74130

  • Investigational Site Number: 2500010

    Dunkirk, 59385

  • Investigational Site Number: 2500047

    Estrées-Deniécourt, 80200

  • Investigational Site Number: 2500049

    Fort-de-france, 97261

  • Investigational Site Number: 2500032

    La Ravoire, 73490

  • Investigational Site Number: 2500044

    La Ravoire, 73490

  • Investigational Site Number : 2500011

    La Roche-sur-Yon, 85925

  • Investigational Site Number: 2500037

    La Tronche, 38700

  • Investigational Site Number: 2500056

    Le Mans, 72000

  • Investigational Site Number: 2500068

    Le Mans, 72000

  • Investigational Site Number : 2500001

    Le Mans, 72037

  • Investigational Site Number: 2500012

    Le Puy-en-Velay, 43000

  • Investigational Site Number: 2500003

    Limoges, 87042

  • Investigational Site Number: 2500031

    Loperhet, 29470

  • Investigational Site Number: 2500067

    Mantes-la-Jolie, 78201

  • Investigational Site Number: 2500060

    Marseille, 13012

  • Investigational Site Number : 2500069

    Marseille, 13885

  • Investigational Site Number: 2500055

    Monaco, 98000

  • Investigational Site Number : 2500058

    Mont-de-Marsan, 40024

  • Investigational Site Number: 2500033

    Niort, 79021

  • Investigational Site Number: 2500065

    Paris, 75005

  • Investigational Site Number: 2500005

    Paris, 75009

  • Investigational Site Number: 2500030

    Paris, 75010

  • Investigational Site Number: 2500071

    Paris, 75017

  • Investigational Site Number: 2500009

    Paris, 75020

  • Investigational Site Number: 2500028

    Périgueux, 24000

  • Investigational Site Number: 2500027

    Périgueux, 24019

  • Investigational Site Number: 2500029

    Rennes, 35000

  • Investigational Site Number: 2500035

    Rennes, 35000

  • Investigational Site Number : 2500021

    Romans-sur-Isère, 26102

  • Investigational Site Number : 2500022

    Rouen, 76031

  • Investigational Site Number: 2500025

    Saint-Etienne, 42100

  • Investigational Site Number: 2500076

    Saint-Martin, 97150

  • Investigational Site Number: 2500034

    Saint-Maur-des-Fossés, 94100

  • Investigational Site Number: 2500045

    Saint-Quentin, 02321

  • Investigational Site Number: 2500057

    Sainte-Eulalie, 15140

  • Investigational Site Number: 2500019

    Sainte-Maxime, 83120

  • Investigational Site Number: 2500015

    Toulouse, 31200

  • Investigational Site Number: 2500016

    Tours, 37044

  • Investigational Site Number: 2500038

    Vannes, 56000

  • Investigational Site Number: 2500024

    Villefranche-sur-Saône, 69655

  • Investigational Site Number : 2500066

    Villeurbanne, 69100

  • Investigational Site Number: 2500052

    Villeurbanne, 69100

Other trials in France

About this study

The objective of the study is to describe the therapeutic management of patients more than or equal to 18 years old eligible for systemic therapy or treated by systemic therapy for atopic dermatitis (AD). This study will be proposed to a sample of French dermatologists experienced in the management of AD, practicing in hospital centers and/or office-based dermatologists. The study will be conducted in real conditions of practice, systemic treatment decisions will be taken at the sole initiative of the participating physician irrespective of the patient enrollment decision. Each patient will be followed-up in routine care setting for 1 year.

Medical subject headings
Dermatitis, Atopic

What participants receive

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

Study groups in NCT06837454
Study groupRoleWhat they receive
Atopic DermatitisThe study plans to collect information on patients during visits according to clinical practice. Enrolled patients will receive AD treatment of marketed drugs prescribed by the specialty physician. No investigational drug will be given for the purpose of this study.

What is being measured

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

  1. Previous and Current Treatments for Atopic Dermatitis (AD)

    List of previous and current treatments for AD based on physician-reported data will be assessed.

    Measured: Baseline, month 6 and month 12

  2. Atopic Comorbidities: Previous and Current Therapeutic Management

    Description of previous and current therapeutic management of atopic comorbidities over time based on physician-reported data will be assessed.

    Measured: Baseline, month 6 and month 12

  3. Change from Baseline in Drug Survival for Systemic Treatments for AD by Name and Dose

    Drug survival is defined as the time from the start of treatment to the end or discontinuation of treatment with no changes. If a patient has multiple drug survival events for the same treatment, the longest drug survival will be used in the data summarization. The drug survival will be illustrated using a Kaplan-Meier plot.

    Measured: Baseline, month 6 and month 12

  4. Compliance for AD Treatments

    Compliance for AD treatments will be assessed by the physician.

    Measured: Baseline, month 6 and month 12

Secondary outcomes (20)
  1. Demographic Characteristics of Participants

    Demographics characteristics including birth date, gender, and socio-professional category, height, weight, phototype (type I to type VI according to Fitzpatrick's classification).

    Measured: Baseline

  2. Medical History and AD history

    Medical history will be summarized using the Medical Dictionary for Regulatory Activities (MedDRA) codes of System Organ Class (SOC) and Preferred Terms (PT).

    Measured: Baseline

  3. Change from Baseline in AD Severity

    Change from baseline in AD severity assessed through physician-reported persistence with prescribed therapy.

    Measured: Baseline, month 6 and month 12

  4. Atopic Comorbidities

    Description of the presence, evolution, and therapeutic management of atopic comorbidities over time based on physician-reported data.

    Measured: Baseline, month 6 and month 12

  5. Non-atopic Comorbidities

    Description of the presence, evolution, and therapeutic management of non-atopic comorbidities over time based on physician-reported data.

    Measured: Baseline, month 6 and month 12

  6. Use of Psychoactive Substances

    Description of the use of psychoactive substances over time based on patient-reported data.

    Measured: Baseline, month 6 and month 12

  7. Change from Baseline in Itch Assessment

    Itch assessment (Worst-Itch Numeric Rating Scale, WI-NRS) will be rated from 0 to 10 on average during the past 7 days, completed by the observing physician after questioning of patient; 0 = no itch and 10 = the worst imaginable itch.

    Measured: Baseline, month 6 and month 12

  8. Change from Baseline in Sleep Disturbance NRS

    NRS sleep disturbance will be rated from 0 to 10 on average during the past 7 days, completed by the observing physician after questioning of patient; 0 = "sleep not disturbed at all" (best possible sleep) and 10 = "sleep extremely disturbed (worst possible sleep)".

    Measured: Baseline, month 6 and month 12

  9. Change from Baseline in Skin Pain NRS

    Skin pain NRS will be rated from 0 to 10 on average during the past 7 days prior to the visit. On a scale of 0 to 10, with 0 being 'no skin pain at all' and 10 being 'the worst imaginable skin pain'.

    Measured: Baseline, month 6 and month 12

  10. Change from Baseline in AD Disease Control Using the Atopic Dermatitis Control Tool (ADCT)

    ADCT is a questionnaire to assess patient-self-perceived control of their AD with a total score from 0 to 24; higher scores indicate lower AD control.

    Measured: Baseline, month 6 and month 12

  11. Change from Baseline in Dermatology Life Quality Index (DLQI)

    DLQI is a 10-item questionnaire to measure dermatology specific quality of life (QoL). DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.

    Measured: Baseline, month 6 and month 12

  12. Change from Baseline in Psychological Comorbidities Assessed using Hospital Anxiety and Depression Scale (HADS)

    The HADS is a 14-item patient-reported outcomes measure used to assess states of anxiety and depression over the past week. It is comprised of 7 items assessing anxiety and depression respectively. A Total score is out of 42 (21 per subscale). Higher scores indicate greater levels of anxiety and/or depression.

    Measured: Baseline, month 6 and month 12

  13. Cumulative Life Course Impairment (CLCI) - for Physicians in Hospital Centers

    CLCI-r instrument determines retrospectively which changes and effects the patients have already experienced due to the disease over their entire disease course.

    CLCI-p determines the patient's current situation and thus identifies risk areas in which the patient could experience burdens in the future.

    Measured: Baseline, month 6 and month 12

  14. Change from Baseline in Patient's Treatment Satisfaction Score Using the Patient Global Assessment of Treatment Effect (PGATE)

    Patient's treatment satisfaction score will be assessed using Patient Global Assessment of Treatment Effect (PGATE). PGATE is an assessment tool used to rate the treatment effect of the medication on atopic dermatitis (AD), with scores ranging from 0 to 4 (0 = poor; 1 = fair; 2 = good; 3 = very good; 4 = excellent), i.e., higher score indicated higher treatment effect.

    Measured: Baseline, month 6 and month 12

  15. Evolution of Atopic Comorbidities

    Evolution of atopic comorbidities over time, assessed through physician-reported status, occurrence of new diagnoses and persistence of existing conditions.

    Measured: Baseline, month 6 and month 12

  16. Management of AD from First Diagnosis

    History of healthcare pathway of participant related to AD will be assessed by the physician (if participant had appointment with other healthcare provider for AD).

    Measured: Baseline, month 6 and month 12

  17. Therapeutic Education

    History of healthcare pathway of participant related to AD will be assessed by the physician (if participant received therapeutic education).

    Measured: Baseline, month 6 and month 12

  18. Cost of Emollients and Hygiene Products

    Cost of emollients, hygiene products etc. during the last month of the study visit will be assessed.

    Measured: At month 12

  19. Sick Leaves Related to AD

    Number of sick leaves participant has taken related to AD since the last visit or over the last 6 months.

    Measured: Baseline, month 6 and month 12

  20. Hospitalization with Overnight Stay Related to AD

    Overnight hospitalization related to AD since the last visit or over the last 6 months.

    Measured: Baseline, month 6 and month 12

Timeline

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

  1. First posted20 Feb 2025
  2. Study start4 Feb 2025
  3. Primary completion13 May 2027 (estimated)
  4. Study completion13 May 2027 (estimated)

Resources

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
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06837454
Sponsor's protocol ID
OBS17667
Other IDs
U1111-1279-3382
Acronym
FRAME
Status last verified
Sep 2026
First submitted
28 Jan 2025
Last updated
28 Sep 2026
Results posted
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

Questions about this trial

What is this clinical trial studying?

An observational study of Atopic Dermatitis, run by Sanofi at 61 sites 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 6 inclusion and 5 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 28 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 61 sites 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?

Previous and Current Treatments for Atopic Dermatitis (AD) (time frame: Baseline, month 6 and month 12). The study lists 4 primary outcomes in all. 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 Sep 2026.

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