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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 de mayo de 2026 actualizado por: 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

Descripción general del estudio

Estado

Terminado

Condiciones

Tipo de estudio

De observación

Inscripción (Actual)

80

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Sujetos con dermatitis atópica
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Datos epidemiológicos
Periodo de tiempo: Visite 2 (desde el día 2 hasta el día 8)
Por un cuestionario completado por todos los sujetos para caracterizar y describir a la población en términos de patología, estado de la piel, hábitos, necesidades y expectativas de los pacientes con respecto al uso de emolientes
Visite 2 (desde el día 2 hasta el día 8)
Efficacy of the cosmetic care product
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

12 de mayo de 2025

Finalización primaria (Actual)

17 de abril de 2026

Finalización del estudio (Actual)

17 de abril de 2026

Fechas de registro del estudio

Enviado por primera vez

12 de mayo de 2025

Primero enviado que cumplió con los criterios de control de calidad

4 de mayo de 2026

Publicado por primera vez (Actual)

11 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

4 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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