Patients With Hidradenitis vs Patients With Psoriasis: Psychological Impact

Psoriasis Clinical Trial

Official title:

A Comparative Retrospective Study Between Patients With Hidradenitis vs Patients With Psoriasis: Psychological Impact

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02999698
• Other study ID #: IIBSP-PSI-2016-71
• Status: Not yet recruiting
• Phase: N/A
• First received: December 19, 2016
• Last updated: December 21, 2016
• Start date: February 2017
• Est. completion date: June 2017

Study information

• Verified date: December 2016
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Esther Margarit de Miguel, Msc
• Phone: +34696617013
• Email: emargarit[@]santpau.cat
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hidradenitis
• Psoriasis

Intervention

Other:
• Observational
Observational

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Universitat Autonoma de Barcelona

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day	No
Primary	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.	1 day	No
Primary	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.	1 day	No
Primary	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.	1 day	No
Secondary	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.	1 day	No
Secondary	Static Physician's Global Assessment (sPGA)	The PGA is a 5 point ordinal rating ranging from "clear" to "very severe psoriasis".	1 day	No
Secondary	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.	1 day	No
Secondary	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	1 day	No