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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
-
-
-
Pierre-Bénite, Frankreich, F-69495
- Allergologie et Immunologie Clinique, CHU Lyon Sud
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
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.
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
Patienten mit atopischer Dermatitis
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Epidemiologische Daten
Zeitfenster: Besuchen Sie 2 (von Tag 2 bis Tag 8)
|
Durch einen von allen Probanden ausfüllten Fragebogen, um die Bevölkerung in Bezug auf Pathologie, Hautzustand, Gewohnheiten, Bedürfnisse und Erwartungen der Patienten in Bezug auf die Verwendung von Emollient zu charakterisieren und zu beschreiben
|
Besuchen Sie 2 (von Tag 2 bis Tag 8)
|
|
Efficacy of the cosmetic care product
Zeitfenster: 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)
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Genetische Krankheiten, angeboren
- Erkrankungen des Immunsystems
- Überempfindlichkeit, sofort
- Überempfindlichkeit
- Hautkrankheiten
- Hautkrankheiten, genetisch
- Hautkrankheiten, Ekzem
- Dermatitis
- Angeborene, erbliche und neonatale Krankheiten und Anomalien
- Haut- und Bindegewebserkrankungen
- Dermatitis, atopisch
Andere Studien-ID-Nummern
- RV4427C20250038
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Atopische Dermatitis
-
Hadassah Medical OrganizationUnbekannt
-
BayerAbgeschlossen
-
MC2 TherapeuticsAbgeschlossenPhototoxizitätVereinigte Staaten
-
Michele SayagAbgeschlossenPrävention von Phototoxizitäten bei Patienten, die sich einer Behandlung mit Vemurafenib unterziehenPhototoxizitätFrankreich
-
Herbarium Laboratorio Botanico LtdaAbgeschlossen
-
University of Nove de JulhoAdriana da Silva MagalhaesZurückgezogenInkontinenz-assoziierte Dermatitis | Windelausschlag | PhotobiomodulationstherapieBrasilien
Klinische Studien zur Investigational cosmetic product RV4427C
-
PfizerEli Lilly and CompanyAbgeschlossenArthroseVereinigte Staaten, Spanien, Australien, Serbien, Deutschland, Kanada, Japan, Neuseeland, Ungarn, Italien, Schweden, Litauen, Portugal, Russische Föderation, Slowakei
-
Hoffmann-La RocheRekrutierungMetastasierter BrustkrebsVereinigte Staaten, Hongkong, Spanien, Kanada, Japan, Vereinigtes Königreich, China, Frankreich, Deutschland, Indien, Singapur, Argentinien, Taiwan, Südafrika, Polen, Kolumbien, Brasilien, Oman, Australien, Jordanien, Mexiko, Belgien und mehr
-
Hoffmann-La RocheAbgeschlossenNeuromyelitis-Optica-Spektrum-StörungVereinigte Staaten, Spanien, Vereinigtes Königreich, Taiwan, Ungarn, Korea, Republik von, Japan, Kroatien, Bulgarien, Kanada, Deutschland, Italien, Polen, Puerto Rico, Rumänien, Truthahn, Ukraine, Malaysia
-
SanofiRekrutierungRespiratory-Syncytial-Virus (RSV) | Influenza A (H5N1)Australien