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OpenTrials
Completed

NCT Number: NCT05555953

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

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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AZIENDA USL TOSCANA CENTRO - Piero Palagi /ID# 245569, Florence, Firenze, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. CORONATE Questionnaire Score

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Acronym: CORONATE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 27, 2022
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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