ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hidradenitis suppurativa

Condition category

Condition code

Skin

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]

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]

Change in HS severity score based on validated assessment tools.
This will be assessed as a composite outcome.

Timepoint [1]

Baseline and at week 6, 12 and 24 after follicular unit extraction.

Primary outcome [2]

Change in pain score

Timepoint [2]

Baseline and at week 6, 12 and 24 after follicular unit extraction.

Primary outcome [3]

Number of abscesses and nodule counts at each visit.
This will be assessed as a composite outcome.

Timepoint [3]

Baseline and at week 6, 12 and 24 after follicular unit extraction.

Secondary outcome [1]

Number and location of disease flares before and after follicular unit extraction.
This will be assessed as a composite outcome.

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Individual

Name

Dr Bevin Bhoyrul

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Royal Melbourne Hospital Human Research Ethics Committee

Ethics committee address [1]

https://www.thermh.org.au/research/researchers/ethics

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/12/2023

Approval date [1]

19/02/2024

Ethics approval number [1]

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

Dr Bevin Bhoyrul

Address

Sinclair Dermatology, 2 Wellington Parade, East Melbourne, VIC 3002

Country

Australia

Phone

+61 3 90130099

Fax

bevin7@hotmail.com

Contact person for public queries

Name

Nicole Kah Mun Yoong

Address

Sinclair Dermatology, 2 Wellington Parade, East Melbourne, VIC 3002

Country

Australia

Phone

+61 449126618

Fax

nicole.yoong@sinclairdermatology.com.au

Contact person for scientific queries

Name

Bevin Bhoyrul

Address

Sinclair Dermatology, 2 Wellington Parade, East Melbourne, VIC 3002

Country

Australia

Phone

+61 3 90130099

Fax

bevin7@hotmail.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

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

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