Completed

NCT Number: NCT07577921

Evaluation of the Efficacy of a Cosmetic Care in Subjects With Moderate to Severe Atopic Dermatitis, Treated by Systemic Treatments

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 aims of this study are to evaluate the efficacy of the cosmetic care product RV4427C WM0071 in subjects suffering from moderate to severe AD, treated and controlled by systemic treatments by assessing the cosmetic satisfaction, perceived effects and habits of use as regards to the use of the cosmetic care product RV4427C WM0071, and to qualify this population of subjects 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 study in adult subjects suffering from moderate to severe AD, treated and controlled by systemic treatments.

3 visits are planned:

* Visit 1 (Day 1): Inclusion * Visit 2 (from Day 2 to Day 8): Intermediate visit - remote visit for subject's questionnaire filling * Visit 3 (Visit 2 + 28 days +/- 2 days): End-of-study visit - remote visit for subject's questionnaire filling

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Allergologie et Immunologie Clinique, CHU Lyon Sud

Pierre-Bénite, F-69495, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 AD controlled by systemic treatment, meaning:

Using systemic treatment for AD (biologics, janus kinase inhibitors or conventional immunosuppressants) initiated for at least 6 months at the time of the inclusion visit
With an unchanged systemic treatment dose for at least 2 months at the time of the inclusion visit,
And with an vIGA-ADTM ≤ 2 (Mild).

Non Inclusion criteria:

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
Subject who has already participated to ADNEEDS study
Subject is in a position likely to represent a conflict of interest and/or is a family member of any people involved in the conduct of the study (secretary, nurse, technician,…), of the investigational site

Criteria related to the diseases / skin condition:

Subject with history of allergy or intolerance to any of the tested product ingredients
Subject having a dermatological condition, an acute, chronic or progressive disease or history of disease liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements

Treatment and study plan

Investigational cosmetic product RV4427C

Other

Product is applied at home by the subject between Visit 2 and Visit 3, 1 to 2 application(s) per day, on face and body, in replacement of the subject's usual product(s). For a subject completing the study, the theoretical product exposure will be 28 days. The maximal product exposure will be 30 days.

Primary outcomes

Epidemiological data

Time frame: Visit 2 (from Day 2 to Day 8)

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
Efficacy of the cosmetic care product

Time frame: Visit 2 (from Day 2 to Day 8) +5 days & Visit 3 (Visit 2 + 28 days +/- 2 days)

By questionnaires filled in by all subjects on cosmetic satisfaction, perceived effects and habits of use

Sponsors and collaborators

Lead sponsor

Pierre Fabre Dermo Cosmetique

Industry

Registry information

Official study title

An Exploratory and Proof of Concept Study to Evaluate the Efficacy of the Cosmetic Care Product RV4427C WM0071 in Subjects Suffering From Moderate to Severe Atopic Dermatitis, Treated and Controlled by Systemic Treatments and Their Needs and Expectations Regarding the Use of Emollient

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: May 11, 2026
Registry last updated: May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed