Effect of Long-term Psoriasis on Patients' Life - CORONATE

EffeCt Of Long-Term PsoRiasis ON PAtienTs' lifE- CORONATE

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05555953

Acronym

CORONATE

Enrollment

543

Registered

2022-09-27

Start date

2023-01-26

Completion date

2024-10-17

Last updated

2024-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

Psoriasis, CORONATE questionnaire

Brief summary

Psoriasis, is an inflammatory chronic skin disease which has a heavy physical and psychosocial impact on participant's life. This is a study to finalize and validate a questionnaire to assess the long-term effect of long-term psoriasis in adult participants. Approximately 550 adult participants with moderate to severe plaque psoriasis will be enrolled in approximately 15 dermatology centers in Italy. Participants will receive standard of care while participating in this study. No drug will be administered as a part of this study. The duration of this study is up to 22 months. There is no additional burden for participants in this study. Participants will attend regular visits during the course of the study at a hospital or clinic.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

Inclusion criteria

* Participants with a diagnosis of moderate-to-severe plaque psoriasis (PASI≥10 or PASI\<10 with involvement of sensitive areas) since at least 10 years. * Adult partner in relationship with the participant since at least 3 years(Part 2 only).

Exclusion criteria

\- Participants with psychiatric conditions.

Design outcomes

Primary

Measure	Time frame	Description
CORONATE Questionnaire Score	Up to 22 months	The CORONATE Questionnaire is a self-administered 25 item questionnaire used to assess the long term effect of moderate to severe psoriasis. Scores range from 0 (false) to 3 (true).

Countries

Italy

Outcome results