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DEFINITIONS
Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12619000802101
Ethics application status
Approved
Date submitted
26/05/2019
Date registered
3/06/2019
Date last updated
22/10/2021
Date data sharing statement initially provided
3/06/2019
Date results information initially provided
22/10/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
The microbiome and role of biofilms in Hidradenitis Suppurativa
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Scientific title
The microbiome and role of biofilms in Hidradenitis Suppurativa
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Secondary ID [1]
297007
0
Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hidradenitis suppurativa
310979
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Condition category
Condition code
Skin
309641
309641
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0
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Dermatological conditions
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Inflammatory and Immune System
311529
311529
0
0
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Other inflammatory or immune system disorders
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Infection
311530
311530
0
0
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Three (3) 6mm punch biopsies of skin - two (2) from affected areas, and one (1) from an unaffected area in each participant. These will take approximately 30 minutes to collect, and will be collected by a dermatology registrar and/or a consultant dermatologist.
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Intervention code [1]
313283
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Not applicable
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Comparator / control treatment
Patient's will be their own controls, as a sample of unaffected skin will be taken as a comparator. Unaffected skin is defined as skin being greater or equal to 2cm from the nearest HS lesion.
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Control group
Active
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Outcomes
Primary outcome [1]
318600
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Determine if biofilms are present in HS using microscopy.
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Assessment method [1]
318600
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Timepoint [1]
318600
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Single skin biopsies collection
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Primary outcome [2]
318601
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Explore the microbial diversity, community structure and function (Microbiome) of HS and the differences between disease stages. This is a composite outcome. This will be assessed through the sampling of patients with lesions with different stages of the disease - Hurley stage I (mild), Hurley stage II (moderate) and Hurley stage III (severe) disease. This will also be assessed through the use of 16s and shotgun genomics.
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Assessment method [2]
318601
0
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Timepoint [2]
318601
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Single skin biopsies collection
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Secondary outcome [1]
365492
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Explore associations between host- microbiome genes and inflammatory markers. This is an exploratory outcome, and will be assessed by the use of 16s and shotgun genomics.
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Assessment method [1]
365492
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Timepoint [1]
365492
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Single skin biopsies collection
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Secondary outcome [2]
365493
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Assess the microbial load (number of bacteria) of HS. This will be assessed through the use of electron scanning microscopy.
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Assessment method [2]
365493
0
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Timepoint [2]
365493
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Single skin biopsies collection
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Secondary outcome [3]
365494
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Assess the histopathology of HS specimens. This will be assessed through histopathological examination of the samples by a pathologist.
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Assessment method [3]
365494
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Timepoint [3]
365494
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Single skin biopsies collection
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Eligibility
Key inclusion criteria
Inclusion criteria is the presence of hidradenitis suppurativa, diagnosed or having had the diagnosis confirmed by a dermatologist.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients will be excluded if they are less than 18 years of age.
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
Clinical metrics and microbiome data will be analysed through Statistical Package for Social Sciences Version 23 (SPSS Inc., Chicago, Illinois, USA). CLC genomics workbench version 8.5.1 in combination with the microbial genome-finishing module (CLC bio, Qiagen Aarhus, Denmark) will allow analysis of DNA sequence data. For all comparisons and modelling, the level of significance was set at p < .05. Data are given as mean, median and SD.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
3/06/2019
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Actual
18/06/2019
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Date of last participant enrolment
Anticipated
31/12/2020
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Actual
13/07/2020
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Date of last data collection
Anticipated
31/12/2020
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Actual
21/07/2020
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Sample size
Target
30
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Accrual to date
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Final
25
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
12842
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Liverpool Hospital - Liverpool
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Recruitment postcode(s) [1]
25314
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2170 - Liverpool
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Funding & Sponsors
Funding source category [1]
301578
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Commercial sector/Industry
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Name [1]
301578
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Sun Pharma
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Address [1]
301578
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2.02/12 Waterloo Rd
Macquarie Park NSW 2113
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Country [1]
301578
0
Australia
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Funding source category [2]
302871
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University
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Name [2]
302871
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Western Sydney University
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Address [2]
302871
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100 Macquarie Street
Liverpool NSW 2170
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Country [2]
302871
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Australia
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Primary sponsor type
Hospital
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Name
Liverpool Hospital, Department of Dermatology
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Address
Elizabeth and Goulburn Streets
Liverpool NSW 2170
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Country
Australia
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Secondary sponsor category [1]
302823
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None
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Name [1]
302823
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None
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Address [1]
302823
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None
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Country [1]
302823
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
302307
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South Western Sydney Local Health District Human Research Ethics Committee
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Ethics committee address [1]
302307
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Level 2, UNSW Clinical School
Liverpool Hospital
NSW 2170
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Ethics committee country [1]
302307
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Australia
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Date submitted for ethics approval [1]
302307
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Approval date [1]
302307
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06/03/2019
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Ethics approval number [1]
302307
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2019/ETH00069
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Summary
Brief summary
In this study we aim to see if biofilms (groups of bacteria) are present in HS lesions, and see what bacteria are present, how they are grouped and what effect they have on the skin and how this relates to disease severity.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
89770
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Dr Jane Woods
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Address
89770
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Department of Dermatology, Liverpool Hospital
Suite 7, Level 1
45-47 Goulburn Street
Liverpool NSW 2170
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Country
89770
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Australia
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Phone
89770
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+61 (02) 8738-4560
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Fax
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Email
89770
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[email protected]
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Contact person for public queries
Name
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Dr Samuel Der Sarkissian
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Address
89771
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Department of Dermatology, Liverpool Hospital
Suite 7, Level 1
45-47 Goulburn Street
Liverpool NSW 2170
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Country
89771
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Australia
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Phone
89771
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61 (02) 8738-4560
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Fax
89771
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Email
89771
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[email protected]
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Contact person for scientific queries
Name
89772
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Dr Samuel Der Sarkissian
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Address
89772
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Department of Dermatology, Liverpool Hospital
Suite 7, Level 1
45-47 Goulburn Street
Liverpool NSW 2170
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Country
89772
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Australia
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Phone
89772
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61 (02) 8738-4560
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Fax
89772
0
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Email
89772
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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