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mMaLeS: Markers in Male Lichen Sclerosus

mMaLeS: Markers in Male Lichen Sclerosus

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000010897
Acronym
mMaLeS
Enrollment
20
Registered
2021-01-11
Start date
2021-01-11
Completion date
Unknown
Last updated
2021-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 a

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.

Sponsors

Darling Downs Health Service, Toowoomba Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Primary purpose
Diagnosis

Eligibility

Sex/Gender
Male
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

Diagnosis of active, lichen sclerosus requiring surgical excision of affected foreskin

Exclusion criteria

Potential malignancy, concomitant disease of the genital skin e.g. HPV

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026