Evaluation of the Efficacy of a Cosmetic Care in Subjects With Moderate to Severe Atopic Dermatitis, Treated by Systemic Treatments
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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Pierre-Bénite, França, F-69495
- Allergologie et Immunologie Clinique, CHU Lyon Sud
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
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.
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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Indivíduos com dermatite atópica
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Dados epidemiológicos
Prazo: Visite 2 (do dia 2 ao dia 8)
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Por um questionário preenchido por todos os sujeitos para caracterizar e descrever a população em termos de patologia, estado da pele, hábitos, necessidades e expectativas dos pacientes em relação ao uso de emoliente
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Visite 2 (do dia 2 ao dia 8)
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Efficacy of the cosmetic care product
Prazo: Visit 2 (from Day 2 to Day 8) +5 days & Visit 3 (Visit 2 + 28 days +/- 2 days)
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By questionnaires filled in by all subjects on cosmetic satisfaction, perceived effects and habits of use
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Visit 2 (from Day 2 to Day 8) +5 days & Visit 3 (Visit 2 + 28 days +/- 2 days)
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças Genéticas, Congênitas
- Doenças do sistema imunológico
- Hipersensibilidade, Imediata
- Hipersensibilidade
- Doenças de pele
- Doenças de Pele Genéticas
- Doenças de Pele, Eczematosas
- Dermatite
- Doenças e Anormalidades Congênitas, Hereditárias e Neonatais
- Doenças da Pele e do Tecido Conjuntivo
- Dermatite Atópica
Outros números de identificação do estudo
- RV4427C20250038
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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