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Trial registered on ANZCTR


Registration number
ACTRN12621000010897
Ethics application status
Approved
Date submitted
24/06/2020
Date registered
11/01/2021
Date last updated
11/01/2021
Date data sharing statement initially provided
11/01/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
mMaLeS: Markers in Male Lichen Sclerosus
Scientific title
mMaLeS: Markers in Male Lichen Sclerosus
Secondary ID [1] 301622 0
none
Universal Trial Number (UTN)
Trial acronym
mMaLeS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lichen sclerosus 318011 0
Condition category
Condition code
Skin 316039 316039 0 0
Dermatological conditions
Renal and Urogenital 317236 317236 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Samples of affected skin and normal skin will be obtained for the surgically excised skin taken in the therapeutic circumcision for the management of lichen sclerosus. These biopsies with be analysed to determine the genetic and proteomic profile to identify markers for early detection and treatment targets.
The intervention (therapeutic circumcision) duration is ~40min performed by a urologist.
From the excised skin, a 5mm biopsy will be taken from both the skin affected by lichen sclerosus and from the health unaffected skin, usually at the margin of the excised specimen or in a clinically unaffected area.
These biopsies will be stored in a reagent in a fridge until transported to the laboratory.
Blood sample 4ml will be taken at the time of anaesthesia approximately 30 min prior to the excision of skin of the circumcision, and stored with the skin biopsies for transport to the laboratory.
Intervention code [1] 317923 0
Diagnosis / Prognosis
Comparator / control treatment
The control group is a paired biopsy of 5mm normal skin taken from the healthy unaffected margin of excised skin at the time of the circumcision.
Control group
Active

Outcomes
Primary outcome [1] 324248 0
Differential gene expression between LS and normal genital skin tissue: gene expression obtained from biopsies via Next Generation Sequencing (RNASeq)
Timepoint [1] 324248 0
At analysis following surgical excision (circumcision)
Primary outcome [2] 324249 0
Differential protein expression between LS and normal genital skin tissue: protein expression obtained from biopsies via Western blot
Timepoint [2] 324249 0
At analysis following surgical excision (circumcision)
Primary outcome [3] 324250 0
Identification of tissue-derived glycoproteins in serum: glycoproteins identified via glycoproteomic technologies using Sodium Dodecyl Sulphate-Polyacrylamide Gel Electrophoresis (SDS-PAGE) and western immunoblotting or mass spectrophotometric analyses.
Timepoint [3] 324250 0
At analysis following surgical excision (circumcision)
Secondary outcome [1] 384171 0
Duration of symptoms prior to surgery using a study specific questionnaire
Timepoint [1] 384171 0
Prior to intervention (Baseline)
Secondary outcome [2] 384172 0
Any previous intervention prior to circumcision
Timepoint [2] 384172 0
Prior to intervention (baseline)

Eligibility
Key inclusion criteria
Diagnosis of active, lichen sclerosus requiring surgical excision of affected foreskin
Minimum age
18 Years
Maximum age
75 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Potential malignancy, concomitant disease of the genital skin e.g. HPV

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/01/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 16982 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [2] 16983 0
St Vincent's Hospital - Toowoomba
Recruitment postcode(s) [1] 30645 0
4350 - Toowoomba

Funding & Sponsors
Funding source category [1] 306053 0
Charities/Societies/Foundations
Name [1] 306053 0
Toowoomba Hospital Foundation
Country [1] 306053 0
Australia
Primary sponsor type
Hospital
Name
Darling Downs Health Service, Toowoomba Hospital
Address
Toowoomba Hospital Campus, Pechey St, Toowoomba QLD 4350
Country
Australia
Secondary sponsor category [1] 306515 0
University
Name [1] 306515 0
University of Southern Queensland
Address [1] 306515 0
West St, Darling Heights QLD 4350
Country [1] 306515 0
Australia
Secondary sponsor category [2] 306516 0
Hospital
Name [2] 306516 0
St Vincent's Hospital Toowoomba
Address [2] 306516 0
22-36 Scott St, Toowoomba City QLD 4350
Country [2] 306516 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306279 0
Darling Downs Human Research Ethics Committe
Ethics committee address [1] 306279 0
Baillie Henderson Hospital
Hogg St and, Tor St, Toowoomba City QLD 4350
Ethics committee country [1] 306279 0
Australia
Date submitted for ethics approval [1] 306279 0
08/05/2020
Approval date [1] 306279 0
25/05/2020
Ethics approval number [1] 306279 0
HREA/2020/QTDD/62491

Summary
Brief summary
Lichen sclerosus (LS), also known as balanitis xerotica obliterans (BXO), is a chronic relapsing inflammatory dermatosis of cryptic aetiology. LS, which usually occurs in the anogenital region of men or women, may cause destructive scarring that can lead to devastating urinary and sexual problems. Clinically it presents as symptoms of itching, pain, dysuria, urinary retention and sexual dysfunction. Specifically, in males, lichen sclerosus may present as phimosis or urethral stricture disease, requiring the involvement of urologists in their care. One third of men were found to have signs of lichen sclerosis without symptoms on examination for other conditions. Lichen sclerosus is a clinically and histologically diagnosed pathological condition with very little understanding of the underlying genetic and proteomic changes that lead to the development and progression of this condition. Skin samples of affected and normal skin will be taken from affected men undergoing circumcision for the treatment of lichen sclersus and analysed to determine the genetic and proteomic profile. The purpose of this study is to investigate the gene and protein expression profile changes in skins affected by LS as compared to normal skin in order to discover the mechanism of the LS, and to further develop targets for diagnosis and effective drugs to treat the condition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103346 0
A/Prof Devang Desai
Address 103346 0
Toowomba Urology, Suite 14, 9 Scott Street, Toowoomba QLD 4350
Country 103346 0
Australia
Phone 103346 0
+61 746328481
Fax 103346 0
+61746328353
Email 103346 0
[email protected]
Contact person for public queries
Name 103347 0
A/Prof Devang Desai
Address 103347 0
Toowoomba Urology, Suite 14, 9 Scott Street, Toowoomba QLD 4350
Country 103347 0
Australia
Phone 103347 0
+61 746328481
Fax 103347 0
+61746328353
Email 103347 0
[email protected]
Contact person for scientific queries
Name 103348 0
A/Prof Devang Desai
Address 103348 0
Toowoomba Urology, Suite 14, 9 Scott Street, Toowoomba QLD 4350
Country 103348 0
Australia
Phone 103348 0
+61 746328481
Fax 103348 0
+61746328353
Email 103348 0
[email protected]

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
8331Study protocol  [email protected]
8332Informed consent form  [email protected]
8333Clinical study report  [email protected]
8334Ethical approval  [email protected] 380072-(Uploaded-24-06-2020-19-42-36)-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.