JMIR Publications

ABSTRACT

Background:

Vulvar lichen sclerosus (LS) is a chronic relapsing dermatosis commonly affecting the anogenital region in post-menopausal women, though it can affect people of any age and sex. Current gold standard treatment is lifelong topical steroid application to reduce symptoms and prevent of progression of disease causing irreversible architectural change to the vulval tissue. LS is associated with decreased quality of life and increased risk of vulvar neoplasia. Alternatives to current treatments are highly desired by both clinicians and patients. Platelet-rich plasma (PRP) is an autologous blood product containing high concentrations of platelets and growth factors and is hypothesised to promote wound healing. PRP has been reported to improve symptoms of LS in a number of case reports and uncontrolled trials.

Objective:

This study aims to evaluate the efficacy of PRP versus saline injections to improve the clinical signs and symptoms of LS.

Methods:

This is a protocol for a 12-month, single-centre, parallel-group, double-blinded, randomised controlled trial evaluating the efficacy of PRP for LS compared to saline. Adult female patients with biopsy-proven LS who are otherwise in good health but are non-responders to topical steroid treatment prior to inclusion are eligible for the trial. A total of 68 participants will be randomly allocated via random number generator to receive either PRP or saline injections to areas of the vulva with LS. All participants will be blinded to the intervention received. Participants will be followed up with assessments of clinical LS signs, subjective symptom scores, and quality of life questionnaires at four time points: baseline, 6 weeks, 6 months, and 12 months by blinded assessors. The primary outcome is the Clinical Scoring System for LS – total LS score.

Results:

The study is closed as of September 2024 due to slow recruitment.

Conclusions:

This study was designed as an RCT to fill in the gap in existing literature about the efficacy of PRP for the treatment of vulvar LS. It aims to provide other researchers in this field with a standardised protocol including methods of preparation and injection of PRP, and the use of validated outcome measures assessing both clinical signs of disease and subjective effects of the disease on quality of life. Clinical Trial: Australia and New Zealand Clinical Trials Registry: ACTRN12618001321235p. Universal Trial Number: U1111-1207-4893.