Description of the Population With Moderate to Severe Atopic Dermatitis, Treated by Systemic Treatments and Needs Regarding Emollients

NCT06983561 | Completed

• 1 other identifier: ADNEEDS
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Atopic dermatitis (AD) is a common chronic inflammatory skin disease, affecting both children (15- 20%) and adults (2-5%). The pathogenesis of AD is complex and multifactorial, including skin barrier dysfunction and immune dysregulation. AD often requires a long management and has a major impact on quality of life. For mild to moderate disease, first-line treatment involves topical therapies including corticosteroids and calcineurin inhibitors. Patients with more severe and refractory symptoms require systemic treatments as phototherapy, conventional systemic treatments (cyclosporine, methotrexate…), biologics and JAK-inhibitors. Regardless of the severity of the disease, additional basic topical treatment with emollient is the mainstay of the management. Emollients, commonly referred to as moisturizing creams are well known for their role in moisture retention, barrier repair and symptom control in AD. Publications on emollient in atopic dermatitis are numerous but there are limited data on how patients with AD treated by systemic treatment use and evaluate emollients. The aim of this study is to characterize and describe the population of subjects suffering from moderate to severe AD, treated and controlled by systemic treatments in terms of pathology, the state of their skin at this stage of their systemic treatment (controlled period), their habits, needs and expectations regarding the use of emollient. This study will be conducted as an exploratory, proof of concept, international, multicentric study in adult subjects suffering from moderate to severe AD, treated and controlled by systemic treatments. 2 visits are planned: Visit 1 (Day 1): Inclusion Visit 2 (from Day 2 to Day 8): End-of-study visit - remote visit for subject's questionnaire filling The maximal duration of participation for a subject is 8 days.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Epidemiological data

  By a questionnaire filled in by all subjects to characterize and describe the population in terms of pathology, state of the skin, habits, needs and expectations of patients regarding the use of emollient

  Visit 2 (from Day 2 to Day 8)

Study Arms (1)

Subject with atopic dermatitis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be enrolled from the investigator's outpatients reception and/or from the database of the centre. The subjects corresponding to eligibility criteria may receive a phone call, a letter or an e-mail proposing to participate to the clinical study.

You may qualify if:

• Criteria related to the population:
• Subject aged between 18 and 75 years included
• Subject having signed his/her written informed consent for his/her participation in the study
• Subject affiliated to a social security system or health insurance, or is a beneficiary (if required by national regulations
• Subject with appropriate hardware (smartphone and/or tablet and/or computer) to complete digital questionnaires
• Subject with a mailbox and internet access to create his account to complete digital questionnaires
• Criteria related to the disease and treatment:
• Subject with moderate to severe atopic dermatitis controlled by systemic treatment, meaning:
• And with an vIGA-ADTM ≤ 2 (Mild).
• Criteria related to the population:
• Subject unable to understand the information given including study procedures (for linguistic or psychiatric reasons) and to give his/her consent in writing and to report required information in writing in the questionnaire
• For woman of childbearing potential: pregnant or breastfeeding or planning to be pregnant during the study
• Subject who has forfeited his/her freedom by administrative or legal award or is under guardianship
• Subject who, in the judgement of the investigator, is not likely to be compliant with study-related constraints and requirements
• Subject who is currently participating, who plans to participate or who has participated within the previous weeks or months in another clinical study liable to interfere with the study assessments according to the investigator's assessment

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Allergologie et Immunologie Clinique, CHU Lyon Sud

Pierre-Bénite, F-69495, France

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 21, 2025
• Study Start: June 16, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-05

Locations

FR (1)