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PSORIASIS RCT 2023

Effectiveness of a digital health application for psoriasis
Source : Importé depuis le centre

Référence clinicaltrials.gov: NCT06027034
Recrutement fermé
Dernière modification : 2025/08/21
Type de recherche

Interventionnel


Population cible

Condition médicale (spécialité visée)

Donnée non disponible

Profil des participants

Limites d'âge
minimum : 18 ans
Sexe(s) des participants

ALL

Source : Importé depuis le centre

Critères de sélection

Critères d'inclusion

Inclusion Criteria:

* Age ≥ 18 years
* Presence of psoriasis vulgaris or psoriatic arthritis
* Submission of a specialist medical certificate attesting to the presence of at least one of the following ICD-10-GM diagnoses: Psoriasis vulgaris (L 40.0, L 40.7), Psoriatic arthritis (L40.5, M07.x)
* Impaired health-related quality of life (DLQI \> 10)
* Consent to participate
* Sufficient understanding of the German language

Exclusion Criteria:

* Presence of another subtype of psoriasis (pustular psoriasis, guttate psoriasis, inverse psoriasis, erythrodermic psoriasis, or drug-induced psoriasis) or psoriatic arthritis without skin involvement
* Presence of malignancies
* Presence of other chronic diseases with strong negative influence on quality of life
* Currently undergoing psychiatric treatment / current presence of a severe psychiatric diagnosis
* Insufficient language and/or IT skills

Source : Importé depuis le centre

Thérapie ou Intervention proposée

Cohortes
Nom Condition médicale Traitement État du recrutement
Online program for psoriasis (GAIA-PSO-01) + TAU Participants allocated to the intervention group will receive access to an online program for psoriasis (GAIA-PSO-01) in addition to treatment as usual (TAU). Donnée non disponible
  • Inconnu
  • TAU Participants allocated to the control group will receive access to treatment as usual (TAU). Donnée non disponible
  • Inconnu
  • Online program for psoriasis (GAIA-PSO-01) + TAU
    État du recrutement
    unknown
    TAU
    État du recrutement
    unknown
    Données à jour depuis : 21 août 2025

    Description de l'étude

    Résumé de l'étude

    This clinical trial with 348 patients with psoriasis aims to investigate the effectiveness of a self-guided online program for patients with psoriasis.

    Patients will be randomized and allocated in a 1:1 ratio to either an intervention group, in which they will receive 12-month-access to an online program for psoriasis in addition to treatment as usual (TAU, n = 174), or to a control group, in which they will receive only TAU (n = 174). TAU is defined as any therapy prescribed or recommended by the GP or specialists (e.g. dermatologist, psychiatrist), which may include topical therapy, phototherapy, pharmacotherapy, psychosocial therapy, etc.

    Source : Importé depuis le centre

    Sites

    Centres participants

      1 centres
    • GAIA AG

      Hamburg

      GERMANY

      Recrutement local
      État du recrutement: FERMÉ

    Dernière modification : 21 août 2025
    Données à jour depuis : 23 août
    Origine des données : clinicaltrials.gov
    Référence clinicaltrials.gov: NCT06027034