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
Type of registration
Prospectively registered

Titles & IDs
Public title
The microbiome and role of biofilms in Hidradenitis Suppurativa
Scientific title
The microbiome and role of biofilms in Hidradenitis Suppurativa
Secondary ID [1] 297007 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hidradenitis suppurativa 310979 0
Condition category
Condition code
Skin 309641 309641 0 0
Dermatological conditions
Inflammatory and Immune System 311529 311529 0 0
Other inflammatory or immune system disorders
Infection 311530 311530 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 313283 0
Not applicable
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.
Control group
Active

Outcomes
Primary outcome [1] 318600 0
Determine if biofilms are present in HS using microscopy.
Timepoint [1] 318600 0
Single skin biopsies collection
Primary outcome [2] 318601 0
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.
Timepoint [2] 318601 0
Single skin biopsies collection
Secondary outcome [1] 365492 0
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.
Timepoint [1] 365492 0
Single skin biopsies collection
Secondary outcome [2] 365493 0
Assess the microbial load (number of bacteria) of HS. This will be assessed through the use of electron scanning microscopy.
Timepoint [2] 365493 0
Single skin biopsies collection
Secondary outcome [3] 365494 0
Assess the histopathology of HS specimens. This will be assessed through histopathological examination of the samples by a pathologist.
Timepoint [3] 365494 0
Single skin biopsies collection

Eligibility
Key inclusion criteria
Inclusion criteria is the presence of hidradenitis suppurativa, diagnosed or having had the diagnosis confirmed by a dermatologist.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they are less than 18 years of age.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/06/2019
Actual
18/06/2019
Date of last participant enrolment
Anticipated
31/12/2020
Actual
13/07/2020
Date of last data collection
Anticipated
31/12/2020
Actual
21/07/2020
Sample size
Target
30
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 12842 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 25314 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 301578 0
Commercial sector/Industry
Name [1] 301578 0
Sun Pharma
Country [1] 301578 0
Australia
Funding source category [2] 302871 0
University
Name [2] 302871 0
Western Sydney University
Country [2] 302871 0
Australia
Primary sponsor type
Hospital
Name
Liverpool Hospital, Department of Dermatology
Address
Elizabeth and Goulburn Streets
Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 302823 0
None
Name [1] 302823 0
None
Address [1] 302823 0
None
Country [1] 302823 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302307 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 302307 0
Ethics committee country [1] 302307 0
Australia
Date submitted for ethics approval [1] 302307 0
Approval date [1] 302307 0
06/03/2019
Ethics approval number [1] 302307 0
2019/ETH00069

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89770 0
Dr Jane Woods
Address 89770 0
Department of Dermatology, Liverpool Hospital
Suite 7, Level 1
45-47 Goulburn Street
Liverpool NSW 2170
Country 89770 0
Australia
Phone 89770 0
+61 (02) 8738-4560
Fax 89770 0
Email 89770 0
manager@drjanewoods.com
Contact person for public queries
Name 89771 0
Samuel Der Sarkissian
Address 89771 0
Department of Dermatology, Liverpool Hospital
Suite 7, Level 1
45-47 Goulburn Street
Liverpool NSW 2170
Country 89771 0
Australia
Phone 89771 0
61 (02) 8738-4560
Fax 89771 0
Email 89771 0
Samueldersarkissian@gmail.com
Contact person for scientific queries
Name 89772 0
Samuel Der Sarkissian
Address 89772 0
Department of Dermatology, Liverpool Hospital
Suite 7, Level 1
45-47 Goulburn Street
Liverpool NSW 2170
Country 89772 0
Australia
Phone 89772 0
61 (02) 8738-4560
Fax 89772 0
Email 89772 0
samueldersarkissian@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.