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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Pierre-Bénite, Frankrike, F-69495
- Allergologie et Immunologie Clinique, CHU Lyon Sud
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
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.
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
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Personer med atopisk dermatit
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Epidemiologiska data
Tidsram: Besök 2 (från dag 2 till dag 8)
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Genom ett frågeformulär som fyllts i av alla försökspersoner för att karakterisera och beskriva befolkningen när det gäller patologi, tillstånd av hud, vanor, behov och förväntningar från patienter när det gäller användning av mjukgörande
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Besök 2 (från dag 2 till dag 8)
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Efficacy of the cosmetic care product
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RV4427C20250038
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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