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Trial registered on ANZCTR


Registration number
ACTRN12615000030572
Ethics application status
Approved
Date submitted
10/12/2014
Date registered
19/01/2015
Date last updated
25/11/2015
Type of registration
Prospectively registered

Titles & IDs
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
Secondary ID [1] 285827 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hidradentitis Suppurativa 293743 0
Condition category
Condition code
Skin 294043 294043 0 0
Dermatological conditions

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure

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.
Intervention code [1] 290806 0
Not applicable
Comparator / control treatment
No comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293821 0
Severity of Hydrdentitis Supperativa (HS).

The questionnaire used to assess the outcome will be the HS Severity Questionnaire which is not yet validated
Timepoint [1] 293821 0
The Questionnaire will be completed during the single study visit to clinic.
Secondary outcome [1] 311931 0
Quality of Life questionnaire to be used in the study is the Dermatology Life Quality Index
Timepoint [1] 311931 0
There is only one single study visit
Secondary outcome [2] 311932 0
Hurley staging
Timepoint [2] 311932 0
There is only one single study visit

Eligibility
Key inclusion criteria
Patients with a diagnosis of Hidradenitis Suppurativa (HS) who are aged 18 years or older will be eligible for this study.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 290398 0
Commercial sector/Industry
Name [1] 290398 0
Abbvie Pty Ltd
Address [1] 290398 0
32-34 Lord Street
Botany NSW 2019
Australia
Country [1] 290398 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Abbvie Pty Ltd
Address
32-34 Lord Street
Botany NSW 2019
Australia
Country
Australia
Secondary sponsor category [1] 289115 0
None
Name [1] 289115 0
Address [1] 289115 0
Country [1] 289115 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292092 0
Bellberry HREC
Ethics committee address [1] 292092 0
129 Glen Osmund Rd Eastwood, Adelaide, South Australia 5063
Ethics committee country [1] 292092 0
Australia
Date submitted for ethics approval [1] 292092 0
03/12/2014
Approval date [1] 292092 0
04/02/2015
Ethics approval number [1] 292092 0

Summary
Brief summary
Hidradenitis Suppurativa (HS) is a chronic skin disease that appears as pea-sized to marble-sized lumps under the skin. The lumps form most often in the armpits, under the breasts, inner thighs, groin and buttocks. HS can be painful and cause scarring and pus in affected areas. Flare-ups may be triggered by perspiration, hormonal changes (such as monthly cycles in women), humidity and heat, and friction from clothing.

The current standard for diagnosing and assessing your condition is called the Hurley Stage Method. This involves a physical assessment of your skin by your doctor.

Recently a new tool has been developed to diagnose Hidradentitis Suppurativa called a ‘self administered questionnaire’.

The purpose of this research is to investigate the predictive ability, sensitivity and specificity of this self-administered questionnaire against the gold-standard clinical assessment of Hidradentitis Suppurativa severity using the Hurley stage method.

The ability of self-administered questionnaires to assess disease severity has not been assessed. A self-administered questionnaire offers advantages over physical assessment, particularly for epidemiologic research into HS where it is important to be able to determine both the prevalence and severity of disease.
Trial website
Trial related presentations / publications
Public notes
Bellberry HREC approval not yet been received as HREC and lead site have been on holidays during Xmas/New Year period so approval has been delayed.

Contacts
Principal investigator
Name 53446 0
Dr Lynda Spelman
Address 53446 0
Veracity Clinical Research
68 Ipswich Road, Woolloongabba, QLD 4102
Country 53446 0
Australia
Phone 53446 0
+61 7 3039 1300
Fax 53446 0
Email 53446 0
spelchat@iinet.net.au
Contact person for public queries
Name 53447 0
Mr LUCIANO ESCUDERO
Address 53447 0
Abbvie Pty Ltd
Level 7, 241 O’Riordan Street
MASCOT NSW 2020
Country 53447 0
Australia
Phone 53447 0
+61 417702391
Fax 53447 0
Email 53447 0
luciano.escuderoherrera@abbvie.com
Contact person for scientific queries
Name 53448 0
Mr LUCIANO ESCUDERO
Address 53448 0
Abbvie Pty Ltd
Level 7, 241 O’Riordan Street
MASCOT NSW 2020
Country 53448 0
Australia
Phone 53448 0
+61 417702391
Fax 53448 0
Email 53448 0
luciano.escuderoherrera@abbvie.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary