PsoriasisNCT02999698
Patients With Hidradenitis vs Patients With Psoriasis: Psychological Impact
An observational study of Psoriasis and Hidradenitis, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Trial summary
The aim of this study is to evaluate the psychological impact of psoriasis or hidradenitis suppurativa on patients, in order to compare both pathologies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis, Hidradenitis
- What is being tested?
- Observational
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Feb 2017to Jun 2017
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with hidradenitis suppurativa or psoriasis who have completed the questionnaires for psychological impact in the Hospital de la Santa Creu and Sant Pau, Barcelona.
Who may be able to join
- Men and women at least 18 years old at the time of selection.
- Subjects diagnosed with psoriasis or hidradenitis suppurativa
- Subjects who had completed the questionnaires for psychological impact.
- Patients should be able to understand and communicate with the investigator.
Who cannot join
- Subjects suffering from a serious concomitant illness.
- Subjects with a mental illness.
- Subjects who are performing psychiatric treatment.
- Patients who have alcohol dependence or drug abuse.
- Subjects that present legal incapacity or limited legal capacity.
- Subjects presenting illiteracy or language barriers.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Comparative Retrospective Study Between Patients With Hidradenitis vs Patients With Psoriasis: Psychological Impact
The aim of this study is to evaluate the psychological impact of psoriasis or hidradenitis suppurativa on patients, in order to compare both pathologies.
- Conditions
- Psoriasis, Hidradenitis
- Being tested
- Observational
- Keywords
- Psoriasis, Hidradenitis, Psychological impact, Quality of life
- Medical subject headings
- Psoriasis, Hidradenitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Observational
| Study group | Role | What they receive |
|---|---|---|
| Psoriasis Group | Patients with psoriasis complete the questionnaires for psychological impact. Receives: Other: Observational | |
| Hidradenitis Suppurativa Group | Patients with hidradenitis suppurativa complete the questionnaires for psychological impact. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dermatology Quality of Life Index (DLQI)
The Dermatology Life Quality Index or DLQI, developed in 1994, was the first dermatology-specific Quality of Life instrument. It is a simple 10-question validated questionnaire that has been used in over 40 different skin conditions in over 80 countries and is available in over 90 languages. Its use has been described in over 1000 publications including many multinational studies. The DLQI is the most frequently used instrument in studies of randomised controlled trials in dermatology.
Measured: 1 day
Hospital Anxiety and Depression Scale (HADS)
Hospital Anxiety and Depression Scale (HADS) was originally developed by Zigmond and Snaith (1983) and is commonly used by doctors to determine the levels of anxiety and depression that a patient is experiencing. The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression.
Measured: 1 day
Perceived Stress Scale (PSS)
Perceived Stress Scale (PSS) was originally developed by Cohen (1983) and this scale is a self-report instrument that evaluates the level of stress perceived during the last month. The scale consists of 14 items with a response format of a five-point scale (0 = never, 1 = almost never, 2 = Every now and then, 3 = often, 4 = very often). The score obtained indicates that a higher score corresponds to a higher level of perceived stress.
Measured: 1 day
The Holmes and Rahe stress scale
The Holmes and Rahe stress scale is a list of 43 stressful life events that can contribute to illness.
Measured: 1 day
Secondary outcomes (4)
Psoriasis Area Severity Index (PASI)
The Psoriasis Area Severity Index (PASI) is an index used to express the severity of psoriasis. It combines the severity (erythema, induration and desquamation) and percentage of affected area.
Measured: 1 day
Static Physician's Global Assessment (sPGA)
The PGA is a 5 point ordinal rating ranging from "clear" to "very severe psoriasis".
Measured: 1 day
Hurley's staging system
Hurley separated patients into three groups based largely on the presence and extent of cicatrization and sinuses. It has been used as a basis for clinical trials in the past and is a useful basis to approach therapy for patients. These three stages are based on Hurley's staging system, which is simple and relies on the subjective extent of the diseased tissue the patient has. Hurley's three stages of hidradenitis suppurativa.
Measured: 1 day
Hidradenitis Suppurativa - Physician Global Assessment (HS-PGA)
The six-point Physician Global Assessment (PGA) ranges from clear to very severe. It is used in clinical trials to measure clinical improvement in inflammatory nodules, abscesses and draining fistulae
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study startFeb 2017
- Primary completionApr 2017 (estimated)
- Study completionJun 2017 (estimated)
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 Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Autonoma de Barcelona
- Responsible party
- Sponsor
- Investigators
- Esther Margarit de Miguel, Msc, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauAntoni Font Guiteras, PhD, Study director, Universitat Autonoma de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999698
- Sponsor's protocol ID
- IIBSP-PSI-2016-71
- Status last verified
- Dec 2016
- First submitted
- 19 Dec 2016
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Retrospective Study Between Patients With Hidradenitis vs Patients With Psoriasis: Psychological Impact
- ClinicalTrials.gov ID
- NCT02999698
- Acronym / sponsor ID
- IIBSP-PSI-2016-71
- Conditions
- Psoriasis, Hidradenitis
- Keywords
- Psoriasis, Hidradenitis, Psychological impact, Quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Universitat Autonoma de Barcelona
- Study start
- Feb 2017
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 21 Dec 2016 (estimated)
- 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.
The aim of this study is to evaluate the psychological impact of psoriasis or hidradenitis suppurativa on patients, in order to compare both pathologies.
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psoriasis Group | – | Other: ObservationalPatients with psoriasis complete the questionnaires for psychological impact. |
| Hidradenitis Suppurativa Group | – | Other: ObservationalPatients with hidradenitis suppurativa complete the questionnaires for psychological impact. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with hidradenitis suppurativa or psoriasis who have completed the questionnaires for psychological impact in the Hospital de la Santa Creu and Sant Pau, Barcelona.
Key inclusion criteria (4 listed)
- Men and women at least 18 years old at the time of selection.
- Subjects diagnosed with psoriasis or hidradenitis suppurativa
- Subjects who had completed the questionnaires for psychological impact.
- Patients should be able to understand and communicate with the investigator.
Key exclusion criteria (6 listed)
- Subjects suffering from a serious concomitant illness.
- Subjects with a mental illness.
- Subjects who are performing psychiatric treatment.
- Patients who have alcohol dependence or drug abuse.
- Subjects that present legal incapacity or limited legal capacity.
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 |
|---|---|---|
| ObservationalObservational | Other | Hidradenitis Suppurativa Group, Psoriasis Group |
Primary outcome
Dermatology Quality of Life Index (DLQI)
Time frame: 1 day
The Dermatology Life Quality Index or DLQI, developed in 1994, was the first dermatology-specific Quality of Life instrument. It is a simple 10-question validated questionnaire that has been used in over 40 different skin conditions in over 80 countries and is available in over 90 languages. Its use has been described in over 1000 publications including many multinational studies. The DLQI is the most frequently used instrument in studies of randomised controlled trials in dermatology.
Hospital Anxiety and Depression Scale (HADS)
Time frame: 1 day
Hospital Anxiety and Depression Scale (HADS) was originally developed by Zigmond and Snaith (1983) and is commonly used by doctors to determine the levels of anxiety and depression that a patient is experiencing. The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression.
Perceived Stress Scale (PSS)
Time frame: 1 day
Perceived Stress Scale (PSS) was originally developed by Cohen (1983) and this scale is a self-report instrument that evaluates the level of stress perceived during the last month. The scale consists of 14 items with a response format of a five-point scale (0 = never, 1 = almost never, 2 = Every now and then, 3 = often, 4 = very often). The score obtained indicates that a higher score corresponds to a higher level of perceived stress.
The Holmes and Rahe stress scale
Time frame: 1 day
The Holmes and Rahe stress scale is a list of 43 stressful life events that can contribute to illness.
4 secondary outcomes
Psoriasis Area Severity Index (PASI)
Time frame: 1 day
Static Physician's Global Assessment (sPGA)
Time frame: 1 day
Hurley's staging system
Time frame: 1 day
Hidradenitis Suppurativa - Physician Global Assessment (HS-PGA)
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2016.
- Individual participant dataSharing planned: No
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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.
Esther Margarit de Miguel, Msc principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Antoni Font Guiteras, PhD study director
Universitat Autonoma de Barcelona
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis and Hidradenitis, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
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 6 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: status not confirmed, as of the sponsor's last update on 22 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esther Margarit de Miguel, Msc (+34696617013, emargarit@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dermatology Quality of Life Index (DLQI) (time frame: 1 day). The study lists 4 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 Dec 2016.