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

4 mai 2026 mis à jour par: Pierre Fabre Dermo Cosmetique

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

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

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Observationnel

Inscription (Réel)

80

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • France
      • Pierre-Bénite, France, F-69495
        • Allergologie et Immunologie Clinique, CHU Lyon Sud

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Sujets atteints de dermatite atopique
Autre: Investigational cosmetic product RV4427C
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Données épidémiologiques
Délai: Visitez 2 (du jour 2 au jour 8)
Par un questionnaire rempli par tous les sujets pour caractériser et décrire la population en termes de pathologie, d'état de la peau, des habitudes, des besoins et des attentes des patients concernant l'utilisation de l'émollient
Visitez 2 (du jour 2 au jour 8)
Efficacy of the cosmetic care product
Délai: 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
Visit 2 (from Day 2 to Day 8) +5 days & Visit 3 (Visit 2 + 28 days +/- 2 days)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Pierre Fabre Dermo Cosmetique

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

12 mai 2025

Achèvement primaire (Réel)

17 avril 2026

Achèvement de l'étude (Réel)

17 avril 2026

Dates d'inscription aux études

Première soumission

12 mai 2025

Première soumission répondant aux critères de contrôle qualité

4 mai 2026

Première publication (Réel)

11 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • RV4427C20250038

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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