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Trial registered on ANZCTR


Registration number
ACTRN12624000388516
Ethics application status
Approved
Date submitted
26/02/2024
Date registered
3/04/2024
Date last updated
3/04/2024
Date data sharing statement initially provided
3/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Hidradenitis suppurativa treated with follicular unit excision: A prospective controlled 24-week pilot study
Scientific title
Effectiveness of follicular unit excision in reducing severity score of Hidradenitis suppurativa: A prospective controlled 24-week pilot study
Secondary ID [1] 311598 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hidradenitis suppurativa 333005 0
Condition category
Condition code
Skin 329699 329699 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective, interventional study to evaluate the effectiveness of follicular unit extraction (FUE) in reducing severity score of mild to moderate Hidradenitis suppurativa (HS).

Follicular unit excision (FUE) is a minimally invasive surgical technique used in hair transplantation surgery where hair grafts are extracted from the donor area and implanted in the recipient area under local anaesthesia. In FUE, the skin around a follicular unit is scored using a 0.8-1 mm circular punch mounted on a motorized hand device, and the graft is subsequently extracted. The extraction leaves a wound which heals by secondary intention. Residual scars are pin-point dots which are virtually imperceptible to the naked eye.

Participants will be taken to the procedure room. Local anaesthesia will be injected into diseased hair-bearing area on both sides of either the axillae or groin. FUE will be performed by the investigator (who is experienced in FUE) using 0.8/0.9/1.0 mm Ertip® punch. The extracted hair follicular unit samples will have histopathological analysis to confirm complete removal of hair follicles, sebaceous glands, aporcrine glands and eccrine glands. These samples are not kept for future studies and will be discarded once complete removal of the pilosebaceous units are confirmed. Participants will not be charged for samples being analysed to confirm complete removal of the pilosebaceous units.

The follicular unit extraction will take approximately 2 hours to complete.

Participants will have 3 subsequent follow ups after the FUE to assess wound healing as well as HS severity.

*Please note that there will be no implantation involved in this procedure. Follicular unit extraction is a technique used in hair transplantation surgeries however this technique will be adopted in this intervention to assess the validity of this technique for HS patients.



Intervention code [1] 328053 0
Treatment: Surgery
Comparator / control treatment
Participants are divided into the intervention group and control group. The control group will be managed with topical 1% clindamycin.

Participants in the control group will have their HS flares managed via the application of topical 1% clindamycin which is part of the mainstay management guidelines for HS. They will be given instructions to apply the cream directly over lesions. Participants will also be given a sheet to document their HS flares and use of topical clindamycin as necessary.
Control group
Active

Outcomes
Primary outcome [1] 337489 0
Change in HS severity score based on validated assessment tools.
This will be assessed as a composite outcome.
Timepoint [1] 337489 0
Baseline and at week 6, 12 and 24 after follicular unit extraction.
Primary outcome [2] 337646 0
Change in pain score
Timepoint [2] 337646 0
Baseline and at week 6, 12 and 24 after follicular unit extraction.
Primary outcome [3] 337647 0
Number of abscesses and nodule counts at each visit.
This will be assessed as a composite outcome.
Timepoint [3] 337647 0
Baseline and at week 6, 12 and 24 after follicular unit extraction.
Secondary outcome [1] 432080 0
Number and location of disease flares before and after follicular unit extraction.
This will be assessed as a composite outcome.
Timepoint [1] 432080 0
At baseline, week 6, 12 and 24 after follicular unit extraction.

Eligibility
Key inclusion criteria
1. Male and female patients with HS aged 18 years and above
2. Mild-moderate HS defined by Hurley stage 1 up to 2A
3. Minimum diagnosis of 3 months prior to baseline
4. Active HS present for at least 3 months from initial diagnosis.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Current treatment with antibiotics, retinoids, immunosuppressants or biologic agents at the discretion of the investigator/research team.
2. Extensive scarring.
3. Absence of terminal hairs in target areas.
4. Previous laser hair removal in target areas.
5. Pregnant or lactating women

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created
by computer software (i.e. computerised sequence
generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Given that this is a pilot study assessing the effectiveness of FUE for HS management, we have decided 24 participants is required as a pilot. The result of this study will be used to inform sample size calculations for future studies as well as account for 20% rate of lost to follow-up.

This pilot study uses 12 participants in each group (intervention vs controlled) and results from this will allow us to calculate the sample size required for statistical power in future clinicals studies.

Abscess and nodule counts will be recorded and then compared at the study visits up to week 24. This will be done using the paired t test.
Paired t test will also be used to compare changes in HS-PGA, IHS4 and HiSCR scores between the treated and control sites.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/04/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315905 0
Self funded/Unfunded
Name [1] 315905 0
Country [1] 315905 0
Primary sponsor type
Individual
Name
Dr Bevin Bhoyrul
Address
Country
Australia
Secondary sponsor category [1] 318052 0
None
Name [1] 318052 0
Address [1] 318052 0
Country [1] 318052 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314753 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 314753 0
https://www.thermh.org.au/research/researchers/ethics
Ethics committee country [1] 314753 0
Australia
Date submitted for ethics approval [1] 314753 0
17/12/2023
Approval date [1] 314753 0
19/02/2024
Ethics approval number [1] 314753 0

Summary
Brief summary
This study is looking at follicular unit extraction to treat hidradenitis suppurativa, a condition that causes inflammation of hair follicles resulting in severe pain and scarring. Follicular unit extraction is a technique used in hair transplants to entirely remove hair follicles. We want to test whether or not by removing hair follicles using hair follicle extraction technique reduces inflammation and improve the quality of patients’ life. We will do hair follicle extraction on both sides of either the armpit or groin and compare it with topical routine treatments to assess whether or not there is improvement. We will follow the participants until week 24 of the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132614 0
Dr Bevin Bhoyrul
Address 132614 0
Sinclair Dermatology, 2 Wellington Parade, East Melbourne, VIC 3002
Country 132614 0
Australia
Phone 132614 0
+61 3 90130099
Fax 132614 0
Email 132614 0
bevin7@hotmail.com
Contact person for public queries
Name 132615 0
Nicole Kah Mun Yoong
Address 132615 0
Sinclair Dermatology, 2 Wellington Parade, East Melbourne, VIC 3002
Country 132615 0
Australia
Phone 132615 0
+61 449126618
Fax 132615 0
Email 132615 0
nicole.yoong@sinclairdermatology.com.au
Contact person for scientific queries
Name 132616 0
Bevin Bhoyrul
Address 132616 0
Sinclair Dermatology, 2 Wellington Parade, East Melbourne, VIC 3002
Country 132616 0
Australia
Phone 132616 0
+61 3 90130099
Fax 132616 0
Email 132616 0
bevin7@hotmail.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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21746Study protocol    387389-(Uploaded-26-02-2024-09-37-26)-Study-related document.pdf
21747Informed consent form    387389-(Uploaded-26-02-2024-09-38-09)-Study-related document.pdf
21748Ethical approval    387389-(Uploaded-26-02-2024-09-37-58)-Study-related document.pdf



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.