PsoriasisPsoSATNCT06102356
Impact of Clinical and Psychological Factors on Treatment Satisfaction in Psoriatic Patients in Biological Therapy
An observational study of Psoriasis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Questionnaire
- How many people
- 104 participants
- Where
- 1 siteItaly
- Study dates
- 13 Sep 2023to 15 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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;
Who cannot join
- Presence of a psychiatric pathology already diagnosed
- Patients with psoriasis variants (pustular, guttate, palmoplantar)
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli
Rome, Lazio, 00168
About this study
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
Read the detailed description
Psoriasis is a chronic inflammatory disease with a significant impact on the quality of life of those affected. The introduction of monoclonal antibodies directed against key cytokines in the pathogenesis of the disease has so far allowed to obtain excellent results not only in terms of objective clinical response (PASI90, PASI100), but also in terms of quality of life (DLQI) thanks to the speed of action, the long-term response and the better safety profile compared to so-called "traditional" drugs, such as cyclosporine, methotrexate and acitretin.
Patient satisfaction is one of the main elements to ensure the success of a systemic therapy for a chronic disease such as psoriasis, as it is closely related to adherence to treatment. Although the literature suggests that treatment satisfaction derives mainly from objective data such as the extent of residual disease, there are no unequivocal data on which values of the disease severity index (PASI) are associated with greater patient satisfaction. Recent studies have also shown that a certain percentage of patients who achieve optimal responses with biological therapies (PASI90, PASI100, absolute PASI <2), still report an impact of the disease on their quality of life (assessed by DLQI) (2021 Life Basel Kirsten et al Which PASI Outcomes Most Relevant to the Patients in Real-World Care?) This paradox has been partly explained by the localization of residual disease in so-called sensitive sites and by the presence of a possible associated symptomatology, but it is still partially unexplored how the psychological profile of the patient can influence this aspect. (DermatolTher 2022 Lebwohl M. et al "Evolution of Patient Perceptions of Psoriatic Disease: Results from the Understanding Psoriatic Disease Leveraging Insights for Treatment (UPLIFT) Survey"). In particular, it remains to be clarified the weight of some psychopathological characteristics of patients and how these can negatively affect the quality of life and consequently satisfaction with treatment. On the other hand, it is known that there is an increased prevalence of numerous psychiatric pathologies in psoriatic patients: depression, bipolar disorder, anxiety, psychosis, cognitive impairment, sexual disorders, sleep disorders, eating behavior and personality disorders. (Rev. Neuroscience, Amanat M. et al "Neurological and psychiatric disorders in psoriasis").
With regard to personality alterations, several studies have shown an increased prevalence (37.4%) of a particular personality profile, Type D, in patients with psoriasis: this is a personality profile characterized by negative emotionality, often associated with a higher incidence of psychiatric diseases (such as anxiety and depression) and which could affect satisfaction with therapies.
- Conditions
- Psoriasis
- Being tested
- Questionnaire
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
DLQI TSQM v.II PHQ-9 DS14
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between PASI and satisfaction
PASI (Psoriasis Activity and Severity Index) (0-72)
Measured: 1 year
Correlation between DLQI and satisfaction
DLQI (Dermatology Life Quality Index) (0-30)
Measured: 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.
Measured: 1 year
Secondary outcomes (2)
Correlation between satisfaction and Type D Personality
"Type D Personality" will be identified through a special validated questionnaire (DS14) that identifies this type of personality in those who obtain scores of "Negative Affectivity" or "Social Inhibition" higher than 10
Measured: 1 year
Correlation between satisfaction and PHQ-9
PHQ-9 investigates the presence "in the last two weeks" of the 9 symptoms of depression according to the DSM-IV also taken up in the DSM-5. Only this question determines the score of the PHQ-9. Each symptom is assessed on a 4-point scale. The second question assesses the functional impairment that depression causes on the normal course of the patient's life. This question does not count towards the PHQ-9 score.
The PHQ-9 score ranges from 0 to 27. Scores between 5 and 9indicate the presence of a subthreshold depression. The score of 10 is the optimal cut-off to highlight clinically relevant depressions
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start13 Sep 2023
- Primary completion15 Apr 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caldarola Giacomo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102356
- Sponsor's protocol ID
- 5601
- Acronym
- PsoSAT
- Status last verified
- Aug 2025
- First submitted
- 21 Oct 2023
- Last updated
- 22 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Clinical and Psychological Factors on Treatment Satisfaction in Psoriatic Patients in Biological Therapy
- ClinicalTrials.gov ID
- NCT06102356
- Acronym / sponsor ID
- PsoSAT / 5601
- Conditions
- Psoriasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Psoriasis is a chronic inflammatory disease with a significant impact on the quality of life of those affected. The introduction of monoclonal antibodies directed against key cytokines in the pathogenesis of the disease has so far allowed to obtain excellent results not only in terms of objective clinical response (PASI90, PASI100), but also in terms of quality of life (DLQI) thanks to the speed of action, the long-term response and the better safety profile compared to so-called "traditional" drugs, such as cyclosporine, methotrexate and acitretin.
Patient satisfaction is one of the main elements to ensure the success of a systemic therapy for a chronic disease such as psoriasis, as it is closely related to adherence to treatment. Although the literature suggests that treatment satisfaction derives mainly from objective data such as the extent of residual disease, there are no unequivocal data on which values of the disease severity index (PASI) are associated with greater patient satisfaction. Recent studies have also shown that a certain percentage of patients who achieve optimal responses with biological therapies (PASI90, PASI100, absolute PASI <2), still report an impact of the disease on their quality of life (assessed by DLQI) (2021 Life Basel Kirsten et al Which PASI Outcomes Most Relevant to the Patients in Real-World Care?) This paradox has been partly explained by the localization of residual disease in so-called sensitive sites and by the presence of a possible associated symptomatology, but it is still partially unexplored how the psychological profile of the patient can influence this aspect. (DermatolTher 2022 Lebwohl M. et al "Evolution of Patient Perceptions of Psoriatic Disease: Results from the Understanding Psoriatic Disease Leveraging Insights for Treatment (UPLIFT) Survey"). In particular, it remains to be clarified the weight of some psychopathological characteristics of patients and how these can negatively affect the quality of life and consequently satisfaction with treatment. On the other hand, it is known that there is an increased prevalence of numerous psychiatric pathologies in psoriatic patients: depression, bipolar disorder, anxiety, psychosis, cognitive impairment, sexual disorders, sleep disorders, eating behavior and personality disorders. (Rev. Neuroscience, Amanat M. et al "Neurological and psychiatric disorders in psoriasis").
With regard to personality alterations, several studies have shown an increased prevalence (37.4%) of a particular personality profile, Type D, in patients with psoriasis: this is a personality profile characterized by negative emotionality, often associated with a higher incidence of psychiatric diseases (such as anxiety and depression) and which could affect satisfaction with therapies.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: QuestionnairePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (2 listed)
- Presence of a psychiatric pathology already diagnosed
- Patients with psoriasis variants (pustular, guttate, palmoplantar)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireDLQI TSQM v.II PHQ-9 DS14 | Other | Cohort 1 |
Primary outcome
Correlation between PASI and satisfaction
Time frame: 1 year
PASI (Psoriasis Activity and Severity Index) (0-72)
Correlation between DLQI and satisfaction
Time frame: 1 year
DLQI (Dermatology Life Quality Index) (0-30)
Correlation between clinical variables and satisfaction
Time frame: 1 year
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.
2 secondary outcomes
Correlation between satisfaction and Type D Personality
Time frame: 1 year
Correlation between satisfaction and PHQ-9
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between PASI and satisfaction (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.