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Trial registered on ANZCTR


Registration number
ACTRN12615000812594
Ethics application status
Approved
Date submitted
8/07/2015
Date registered
5/08/2015
Date last updated
23/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Epidemiological study of Hidradenitis Suppurativa (HS) to determine the prevalence and severity of the disease in the Australian population.
Scientific title
A two stage, epidemiological, cross-sectional survey study of the Australian population, to determine the prevalence and severity of Hidradenitis Suppurativa (HS).
Secondary ID [1] 287057 0
Nil
Universal Trial Number (UTN)
Trial acronym
HS-Epi
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hidradenitis Suppurativa 295541 0
Condition category
Condition code
Skin 295819 295819 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 a two stage cross-sectional, observational survey study to determine the prevalence and severity of HS in the Australian population. No intervention will be administered and the population will not be exposed to an exposure factor.
Stage one: Screening of the Australian population for those who potentially have HS
The ‘Single Source Establishment Survey’ is a household survey conducted by an Australian market research company, with purpose to obtain demographic data from individuals aged 18 years and over. The ‘Single Source Survey’ covers all Australian States and Territories. Questions that indicate a potential diagnosis of HS, will be added to the ‘Single Source Survey’ administered in all Australian States and Territories, except the Northern Territory*.
Prior the specific HS questions being asked, the interviewee will be asked if he or she verbally consents to being asked these questions.
If the interviewee qualifies for a potential HS diagnosis, he or she will then be asked to participate in stage two.
*The Northern Territory has been excluded from this study due to lack of a local dermatology clinic to confirm diagnosis in stage two.
Stage two: Dermatology consult, diagnosis confirmation and severity assessment
If the subject provides written consent to participating in the study, a researcher will then contact them and invite them to participate in a dermatology consult at a participating local dermatology clinic. If the subject agrees, upon their arrival to the clinic, they will provide written consent to participating in the research study, undergoing a physical examination and having clinical photographs taken by a dermatologist, as well as the storage and future use of the information collected. The clinician will record the diagnosis and clinical notes on severity on a form. All patient data including written information and clinical photographs will be de-identified.
Confirmation of HS diagnosis and confirmation of moderate to severe HS diagnosis will be made by the attending dermatologist according to Hurley Stage System, as well as via a central expert review of the clinical notes and photographs.
Data collected will be statistically analysed to determine the prevalence and severity of HS in the Australian population.
No medication or treatment will be administered.
Intervention code [1] 292288 0
Not applicable
Comparator / control treatment
No comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295511 0
Prevalence of HS - based on dermatologist diagnosis of HS, and the statistical analysis of the number of diagnoses in the Australian population.
Timepoint [1] 295511 0
Measured after a dermatologist has reviewed a patient for HS and confirmed diagnosis, and a central expert dermatologist has reviewed all cases for consistency in diagnosis. Statistical analysis of the data collected will be then be conducted to determine prevalence. Anticipated to be a month after all surveys are conducted.
Secondary outcome [1] 315740 0
Severity of HS via Hurley Stage method - based on dermatologist diagnosis of moderate to severe HS, and the statistical analysis of the number of moderate to severe cases in the Australian population.
Timepoint [1] 315740 0
Measured after a dermatologist has reviewed a patient for HS, confirmed diagnosis, provided severity as per the Hurley Stage Method, and a central expert dermatologist has reviewed all cases for consistency in severity grading. Statistical analysis of the data collected will be then be conducted to determine severity in the Australian population. Anticipated to be a month after all surveys are conducted.

Eligibility
Key inclusion criteria
All those who participates in the 'Single Source Survey'.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those who are under 18 years of age and have not consented to the 'Single Source Survey' .

Study design
Purpose
Duration
Cross-sectional
Selection
Random sample
Timing
Statistical methods / analysis
Data from the survey will be categorised according to HS and non-HS groups. Frequency count and the percentage of subjects within each category will be calculated. Comparison between HS group and non-HS group will be done using an independent T-test. Crude prevalence rates for HS and their 95% CI will be estimated using the number of confirmed HS diagnoses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/08/2015
Actual
15/08/2015
Date of last participant enrolment
Anticipated
30/10/2015
Actual
11/12/2015
Date of last data collection
Anticipated
30/10/2015
Actual
8/02/2016
Sample size
Target
7000
Accrual to date
Final
11433
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 291617 0
Commercial sector/Industry
Name [1] 291617 0
Abbvie Pty Ltd
Country [1] 291617 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
AbbVie Pty Ltd
Address
32-34 Lord Street
Botany NSW 2019
Country
Australia
Secondary sponsor category [1] 290288 0
None
Name [1] 290288 0
Address [1] 290288 0
Country [1] 290288 0
Other collaborator category [1] 278531 0
Other Collaborative groups
Name [1] 278531 0
George Clinical, as part of The George Institute
Address [1] 278531 0
Level 13/321 Kent St Sydney, NSW 2000
Country [1] 278531 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293149 0
Bellberry HREC
Ethics committee address [1] 293149 0
129 Glen Osmund Rd Eastwood, Adelaide, South Australia 5063
Ethics committee country [1] 293149 0
Australia
Date submitted for ethics approval [1] 293149 0
17/06/2015
Approval date [1] 293149 0
11/08/2015
Ethics approval number [1] 293149 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 objectives of this study are to determine the prevalence of HS in the Australian population and characterize the patterns of disease severity in this patient population.

A cross-sectional, observational, population-based study will be used to investigate the epidemiology of HS. The study will be administered via a survey.

If responses indicate that the participant potentially has HS, they will be contacted by a researcher to invite them to attend a dermatology clinic for further assessment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58666 0
Dr Diana Rubel
Address 58666 0
Woden Dermatology: Level 1, 1 Bowes Place, Phillip ACT 2606
Country 58666 0
Australia
Phone 58666 0
+61262828410
Fax 58666 0
Email 58666 0
[email protected]
Contact person for public queries
Name 58667 0
Ms Helen Valcanis
Address 58667 0
AbbVie Pty Ltd: Level 7, 241 O’Riordan Street
Mascot NSW 2020
Country 58667 0
Australia
Phone 58667 0
+61 447 620 031
Fax 58667 0
Email 58667 0
[email protected]
Contact person for scientific queries
Name 58668 0
Ms Helen Valcanis
Address 58668 0
AbbVie Pty Ltd: Level 7, 241 O’Riordan Street
Mascot NSW 2020
Country 58668 0
Australia
Phone 58668 0
+61 447 620 031
Fax 58668 0
Email 58668 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.