|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ANZCTR |
|
Last refreshed on:
|
13 January 2020 |
|
Main ID: |
ACTRN12615000030572 |
|
Date of registration:
|
19/01/2015 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Validation of a self-administered questionnaire to determine the severity of Hidradenitis Suppurativa
|
|
Scientific title:
|
Hurley staging versus self administered questionnaire to determine the severity of Hydradentitis Suppurativa |
|
Date of first enrolment:
|
04/03/2015 |
|
Target sample size:
|
120 |
|
Recruitment status: |
Completed |
|
URL:
|
https://anzctr.org.au/ACTRN12615000030572.aspx |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
Not Applicable
|
|
|
Countries of recruitment
|
|
Australia
| | | | | | | |
|
Contacts
|
|
Name:
|
Mr LUCIANO ESCUDERO
|
|
Address:
|
Abbvie Pty Ltd
Level 7, 241 O’Riordan Street
MASCOT NSW 2020
Australia |
|
Telephone:
|
+61 417702391 |
|
Email:
|
luciano.escuderoherrera@abbvie.com |
|
Affiliation:
|
|
|
|
Name:
|
Mr LUCIANO ESCUDERO
|
|
Address:
|
Abbvie Pty Ltd
Level 7, 241 O’Riordan Street
MASCOT NSW 2020
Australia |
|
Telephone:
|
+61 417702391 |
|
Email:
|
luciano.escuderoherrera@abbvie.com |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: Patients with a diagnosis of Hidradenitis Suppurativa (HS) who are aged 18 years or older will be eligible for this study.
Exclusion criteria: No exclusion criteria
Age minimum:
18 Years
Age maximum:
No limit
Gender:
Both males and females
|
|
Health Condition(s) or Problem(s) studied
|
Hidradentitis Suppurativa;
Hidradentitis Suppurativa
|
|
Skin - Dermatological conditions
|
|
Intervention(s)
|
This cross sectional observational study will used to compare a self administered questionnaire against a gold standard clinical assessment for diagnosis of severity of Hydradentitis Supperativa (HS). The gold standard clinical assessment will be the Hurley stage method.
The medical care of the patient will not alter as a result of being involved in this study.
The patient will visit a clinic for 1-2 hours where the patient will complete the self administered HS questionnaire, Quality of Life questionnaire and undergo clinical assessment.
Study endpoints will be the Hurley Stage, DLQi and the completed HS severity questionnaire. The utility of each of the possible 8 questions of the questionnaire will be evaluated through regression models and the agreement determined between the best model and the Hurley stage method.
|
|
Primary Outcome(s)
|
Severity of Hydrdentitis Supperativa (HS).
The questionnaire used to assess the outcome will be the HS Severity Questionnaire which is not yet validated[The Questionnaire will be completed during the single study visit to clinic.]
|
|
Secondary Outcome(s)
|
|
Hurley staging[There is only one single study visit]
|
|
Quality of Life questionnaire to be used in the study is the Dermatology Life Quality Index[There is only one single study visit]
|
|
Secondary ID(s)
|
|
Nil known
|
|
Source(s) of Monetary Support
|
|
Abbvie Pty Ltd
|
|
Ethics review
|
Status: Approved
Approval date:
Contact:
Bellberry HREC
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|