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Recruiting NCT06837454

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

— Observational Atopic Dermatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Atopic Dermatitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • Previous and Current Treatments for Atopic Dermatitis (AD) [Time frame: Baseline, month 6 and month 12]
  • Atopic Comorbidities: Previous and Current Therapeutic Management [Time frame: Baseline, month 6 and month 12]
  • Change from Baseline in Drug Survival for Systemic Treatments for AD by Name and Dose [Time frame: Baseline, month 6 and month 12]
  • Compliance for AD Treatments [Time frame: Baseline, month 6 and month 12]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 62 centers
  • Investigational Site Number: 2500051 — Aix-en-Provence
  • Investigational Site Number: 2500023 — Amiens
  • Investigational Site Number: 2500004 — Angers
  • Investigational Site Number: 2500017 — Angers
  • Investigational Site Number: 2500050 — Arès
  • Investigational Site Number: 2500063 — Arès
  • Investigational Site Number: 2500054 — Bayonne
  • Investigational Site Number: 2500043 — Bezannes
  • … and 54 more centers

Identifiers

NCT: NCT06837454 · OBS17667 · U1111-1279-3382

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗