Impact of Clinical and Psychological Factors on Treatment Satisfaction in Psoriatic Patients in Biological Therapy

NCT06102356 | Completed

• 1 other identifier: 5601
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to identify, through the use of questionnaires, demographic, clinical and psychological factors that could better correlate with the satisfaction of psoriatic patients in systemic therapy with biological drugs for more than a year belonging to the Dermatology Clinics of the A. Gemelli-IRCCS University Hospital

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (3)

• Correlation between PASI and satisfaction

  PASI (Psoriasis Activity and Severity Index) (0-72)

  1 year

• Correlation between DLQI and satisfaction

  DLQI (Dermatology Life Quality Index) (0-30)

  1 year

• Correlation between clinical variables and satisfaction

  Satisfaction is measured via TSQM v.II. TSQM v.II has 11 questions in four subscales including effectiveness, side effects, convenience of use and overall satisfaction. The sum of the scores of each subscale is displayed as a number from zero to 100.

  1 year

Secondary Outcomes (2)

• Correlation between satisfaction and Type D Personality

  1 year

• Correlation between satisfaction and PHQ-9

  1 year

Study Arms (1)

Cohort 1

Patients diagnosed with Psoriasis referred to the outpatient clinics of Dermatology and Venereology of FPG already treated with a systemic biologic drug for at least one year.

Other: Questionnaire

Interventions

Questionnaire OTHER

DLQI TSQM v.II PHQ-9 DS14

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with psoriasis belonging to the Dermatology and Venereology clinics of FPG already treated with a systemic biological drug for at least one year will be included

You may qualify if:

• Patients with age\>18 years, of both sexes;
• Diagnosis of plaque psoriasis, with or without concomitant arthritis
• Patients who have been receiving systemic biologics for at least one year and have disease severity (PASI) and quality of life (DLQI) data available at baseline (prior to initiation of treatment);
• Signature of the written informed consent;

You may not qualify if:

• Presence of a psychiatric pathology already diagnosed
• Patients with psoriasis variants (pustular, guttate, palmoplantar)

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli

Rome, Lazio, 00168, Italy

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: October 21, 2023
• First Posted: October 26, 2023
• Study Start: September 13, 2023
• Primary Completion: April 15, 2024
• Study Completion: June 15, 2024
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

IT (1)