Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Evaluation of the Efficacy of a Cosmetic Care in Subjects With Moderate to Severe Atopic Dermatitis, Treated by Systemic Treatments

4. maj 2026 opdateret af: 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

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

80

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Personer med atopisk 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Epidemiologiske data
Tidsramme: Besøg 2 (fra dag 2 til dag 8)
Ved et spørgeskema udfyldt af alle emner for at karakterisere og beskrive befolkningen med hensyn til patologi, tilstand af hud, vaner, behov og forventninger til patienter med hensyn til brugen af ​​blødgørende
Besøg 2 (fra dag 2 til dag 8)
Efficacy of the cosmetic care product
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

12. maj 2025

Primær færdiggørelse (Faktiske)

17. april 2026

Studieafslutning (Faktiske)

17. april 2026

Datoer for studieregistrering

Først indsendt

12. maj 2025

Først indsendt, der opfyldte QC-kriterier

4. maj 2026

Først opslået (Faktiske)

11. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Atopisk dermatitis

Kliniske forsøg med Investigational cosmetic product RV4427C

Abonner