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.
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
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.
- Conditions
- Atopic Dermatitis
- 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 group | Role | What they receive |
|---|---|---|
| Atopic Dermatitis | The 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.
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
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
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
Compliance for AD Treatments
Compliance for AD treatments will be assessed by the physician.
Measured: Baseline, month 6 and month 12
Secondary outcomes (20)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted20 Feb 2025
- Study start4 Feb 2025
- Primary completion13 May 2027 (estimated)
- Study completion13 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Prospective Observational Study in Patients Eligible for Systemic Therapy for Atopic Dermatitis (AD)
- ClinicalTrials.gov ID
- NCT06837454
- Acronym / sponsor ID
- FRAME / OBS17667
- Conditions
- Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- 13 May 2027 (estimated)
- Study completion
- 13 May 2027 (estimated)
- First posted
- 20 Feb 2025 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atopic Dermatitis | – | –The 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (6 listed)
- Signed informed consent form.
- Patient with moderate to severe AD according to the Investigator's judgment and
- or
- Able to understand and complete study-related questionnaires.
Key exclusion criteria (5 listed)
- 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.
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
Previous and Current Treatments for Atopic Dermatitis (AD)
Time frame: Baseline, month 6 and month 12
List of previous and current treatments for AD based on physician-reported data will be assessed.
Atopic Comorbidities: Previous and Current Therapeutic Management
Time frame: Baseline, month 6 and month 12
Description of previous and current therapeutic management of atopic comorbidities over time based on physician-reported data will be assessed.
Change from Baseline in Drug Survival for Systemic Treatments for AD by Name and Dose
Time frame: Baseline, month 6 and month 12
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.
Compliance for AD Treatments
Time frame: Baseline, month 6 and month 12
Compliance for AD treatments will be assessed by the physician.
20 secondary outcomes
Demographic Characteristics of Participants
Time frame: Baseline
Medical History and AD history
Time frame: Baseline
Change from Baseline in AD Severity
Time frame: Baseline, month 6 and month 12
Atopic Comorbidities
Time frame: Baseline, month 6 and month 12
Non-atopic Comorbidities
Time frame: Baseline, month 6 and month 12
Use of Psychoactive Substances
Time frame: Baseline, month 6 and month 12
Change from Baseline in Itch Assessment
Time frame: Baseline, month 6 and month 12
Change from Baseline in Sleep Disturbance NRS
Time frame: Baseline, month 6 and month 12
Change from Baseline in Skin Pain NRS
Time frame: Baseline, month 6 and month 12
Change from Baseline in AD Disease Control Using the Atopic Dermatitis Control Tool (ADCT)
Time frame: Baseline, month 6 and month 12
Change from Baseline in Dermatology Life Quality Index (DLQI)
Time frame: Baseline, month 6 and month 12
Change from Baseline in Psychological Comorbidities Assessed using Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, month 6 and month 12
Cumulative Life Course Impairment (CLCI) - for Physicians in Hospital Centers
Time frame: Baseline, month 6 and month 12
Change from Baseline in Patient's Treatment Satisfaction Score Using the Patient Global Assessment of Treatment Effect (PGATE)
Time frame: Baseline, month 6 and month 12
Evolution of Atopic Comorbidities
Time frame: Baseline, month 6 and month 12
Management of AD from First Diagnosis
Time frame: Baseline, month 6 and month 12
Therapeutic Education
Time frame: Baseline, month 6 and month 12
Cost of Emollients and Hygiene Products
Time frame: At month 12
Sick Leaves Related to AD
Time frame: Baseline, month 6 and month 12
Hospitalization with Overnight Stay Related to AD
Time frame: Baseline, month 6 and month 12
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 Sep 2026.
- Individual participant dataSharing planned: 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
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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.
61 sites 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, 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.