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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with atopic dermatitis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Efficacy of the cosmetic care product | 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) |
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Inclusion Criteria:
Criteria related to the population:
Criteria related to the disease and treatment:
• Subject with moderate to severe AD controlled by systemic treatment, meaning:
Non Inclusion criteria:
Criteria related to the population:
Criteria related to the diseases / skin condition:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergologie et Immunologie Clinique, CHU Lyon Sud | Pierre-Bénite | F-69495 | France |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |