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Trial registered on ANZCTR


Registration number
ACTRN12618001321235p
Ethics application status
Submitted, not yet approved
Date submitted
8/07/2018
Date registered
6/08/2018
Date last updated
6/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Is platelet-rich plasma (a blood product) helpful in treating lichen sclerosus on the vulva (external female genitalia)?
Scientific title
The role of regenerative medicine for treatment of vulval lichen sclerosus: A randomised control trial of platelet-rich plasma (PRP) versus normal saline
Secondary ID [1] 295460 0
none
Universal Trial Number (UTN)
U1111-1207-4893
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
vulvar lichen sclerosus 308715 0
Condition category
Condition code
Renal and Urogenital 307658 307658 0 0
Other renal and urogenital disorders
Skin 307659 307659 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 - Platelet-rich plasma (PRP) is an autologous blood product that will be used to inject into the vulva at the lichen sclerosus lesion. PRP is the study treatment.

Arm 2 – Normal saline will be used to inject into the vulva at the lichen sclerosus lesion as a placebo in this trial.

Informational materials will be the Participant Information and Consent form. The principal investigator will deliver the intervention and placebo treatment. Participants will have two treatments 6 weeks apart at FBW Gynaecology Plus. Assessment is at 6 weeks, 6 months, and 12 months.

The first visit is for initial assessment and randomization into the study. The first treatment may occur at the time of the initial assessment. A second treatment will be 6 weeks after the first treatment. The injections into the vulva will be a maximum of 4 mls of PRP or placebo. It may be less if it becomes evident through visual inspection that the tissue cannot hold the maximum amount.

Subsequent clinical reviews will be at 6 months and 12 months after the first treatment.
Intervention code [1] 301775 0
Treatment: Other
Comparator / control treatment
The normal saline syringe will be injected underneath the vulval mucosa at the area affected by lichen sclerosus using a 30-gauge needle.

The technique of injection that will be employed will be a maximum of 4 mls. It may be less if it becomes evident through visual inspection that the tissue cannot hold the maximum amount.
Control group
Placebo

Outcomes
Primary outcome [1] 306645 0
The differences in symptoms of vulvar lichen sclerosus after PRP treatment assessed by Australian Pelvic Floor Questionnaire and the Dermatology Life Quality Index.
Timepoint [1] 306645 0
baseline, 6 weeks, 6 months (primary timepoint), and 12 months after randomisation
Primary outcome [2] 306744 0
To assess changes in lesions of vulvar lichen sclerosus with PRP assessed by clinical scoring for vulvar lichen sclerosus
Timepoint [2] 306744 0
baseline, 6 weeks, 6 months (primary timepoint), and 12 months after randomisation
Secondary outcome [1] 349110 0
Composite score of lichen sclerosus symptomes, such as dyspareunia, sexual function, and quality of life based on Australian Pelvic Floor Questionnaire..
Timepoint [1] 349110 0
baseline, 6 weeks, 6 months, and 12 months after randomisation
Secondary outcome [2] 349111 0
Genitourinary syndrome of menopause grade based on medical records.
Timepoint [2] 349111 0
baseline, 6 weeks, 6 months, and 12 months after randomisation
Secondary outcome [3] 349112 0
Complications after PRP treatment from medical chart review, for instance haematoma, infection, and disease progression.
Timepoint [3] 349112 0
baseline, 6 weeks, 6 months, and 12 months after randomisation
Secondary outcome [4] 349113 0
level of discomfort from PRP treatment by visual analogue scale
Timepoint [4] 349113 0
baseline, 6 weeks, 6 months, and 12 months after randomisation

Eligibility
Key inclusion criteria
a) Are female patients over the age of 18;
b) Have been formally diagnosed with lichen sclerosus;
c) Remain symptomatic from vulvar lichen sclerosus despite topical steroid treatment prior to the beginning of the study or women who are unable to use or are intolerant of topical steroid use;
d) Understand the conditions of the study fully and are willing to participate for the length of the study in its entirety;
e) Are capable of, and have given, informed consent to their participation in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Patients on anti-oestrogens.
b) Patients on systemic immunosuppressant within 12 weeks prior to participating in the study.
c) Patients currently suffering any gynaecological or breast cancers.
d) Patients with autoimmune disorders requiring anti-platelet medication, except Sjogren’s syndrome and lichen sclerosus.
e) Patient who are immunocompromised (e.g. lymphoma, AIDS) or have uncontrolled malignant disease.
f) Patient who have been diagnosed with lichen planus, psoriasis, candidiasis, vulvar intraepithelial neoplasia, or vulvar carcinoma.
g) Patients with vulvodynia.
h) Patients with acute vaginal infection or systemic infection.
i) Patients on anti-platelet treatment.
j) Patients on aspirin.
k) Patients who have a mental disability leading to their inabilty to give consent.
l) Patients who are pregnant.
m) Patients who are uncooperative, known to miss appointments, are unlikely to follow medical instructions, or unable to attend regular scheduled visits.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Based on the pilot study on 28 patients (Behnia-Willison 2016), 80% of the PRP-treated patients experimented an improvement of their condition. Assuming a difference of 30% between PRP treatment and normal saline placebo at 12 months, an alpha risk of 5% and a power of 80%, a sample size of 31 subjects for the PRP group and 31 subjects for the normal saline group is required. Assuming that up to 10% subjects may be lost to follow-up or withdrawn, a sample size of 34 subjects for the PRP group and 34 subjects for the normal saline group is required, for a total sample size of 68 patients.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/09/2018
Actual
Date of last participant enrolment
Anticipated
1/04/2019
Actual
Date of last data collection
Anticipated
1/04/2020
Actual
Sample size
Target
68
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment postcode(s) [1] 23235 0
5035 - Ashford
Recruitment postcode(s) [2] 23236 0
2065 - St Leonards
Recruitment outside Australia
Country [1] 10626 0
Italy
State/province [1] 10626 0
Country [2] 10627 0
Ireland
State/province [2] 10627 0
Country [3] 10628 0
Puerto Rico
State/province [3] 10628 0

Funding & Sponsors
Funding source category [1] 300051 0
Charities/Societies/Foundations
Name [1] 300051 0
Australasian Gynaecological Endoscopy and Surgery Society
Country [1] 300051 0
Australia
Primary sponsor type
Individual
Name
Dr Fariba Behnia Willison
Address
FBW Gynaecology Plus
46 Marleston Ave
Ashford SA 5035
Country
Australia
Secondary sponsor category [1] 299447 0
None
Name [1] 299447 0
none
Address [1] 299447 0
none
Country [1] 299447 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 300898 0
Bellberry
Ethics committee address [1] 300898 0
Ethics committee country [1] 300898 0
Australia
Date submitted for ethics approval [1] 300898 0
08/07/2018
Approval date [1] 300898 0
Ethics approval number [1] 300898 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2869 2869 0 0
/AnzctrAttachments/375536-RCT PRP Ethics application 2018-07-04.docx (Protocol)
Attachments [2] 2870 2870 0 0
/AnzctrAttachments/375536-3. Participant Information and Consent Form 2017 v3.docx (Participant information/consent)
Attachments [3] 2871 2871 0 0
/AnzctrAttachments/375536-1. GOX-D-16-00463 copy.pdf (Publication)

Contacts
Principal investigator
Name 85202 0
Dr Fariba Behnia Willison
Address 85202 0
FBW Gynaecology Plus
46 Marleston Avenue
Ashford, SA 5035
Country 85202 0
Australia
Phone 85202 0
+61882972822
Fax 85202 0
Email 85202 0
fbw@fbwgynplus.com
Contact person for public queries
Name 85203 0
Tran Nguyen
Address 85203 0
FBW Gynaecology Plus
46 Marleston Avenue
Ashford, SA 5035
Country 85203 0
Australia
Phone 85203 0
+61882972822
Fax 85203 0
Email 85203 0
DrNguyen@fbwgynplus.com
Contact person for scientific queries
Name 85204 0
Tran Nguyen
Address 85204 0
FBW Gynaecology Plus
46 Marleston Avenue
Ashford, SA 5035
Country 85204 0
Australia
Phone 85204 0
+61882972822
Fax 85204 0
Email 85204 0
DrNguyen@fbwgynplus.com

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

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