Nguyen Tran, Beljic Milica, Willison Nadia, Taheri Mahshid, Aryan Pouria, Abbott Derek, Behnia-Willison Fariba
Discipline of Biomedical Engineering, School of Electrical and Mechanical Engineering, University of Adelaide, Adelaide, Australia.
FBW Gynaecology Plus, Ashford, Australia.
JMIR Res Protoc. 2025 Sep 3;14:e68871. doi: 10.2196/68871.
Vulvar lichen sclerosus (LS) is a chronic relapsing dermatosis commonly affecting the anogenital region in postmenopausal women, though it can affect people of any age and sex. The current gold standard treatment is lifelong topical steroid application to reduce symptoms and prevent the 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 hypothesized to promote wound healing. PRP has been reported to improve symptoms of LS in several case reports and uncontrolled trials.
This study aims to evaluate the efficacy of PRP versus saline injections to improve the clinical signs and symptoms of LS.
This is a protocol for a 12-month, single-center, parallel-group, double-blind, randomized 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 nonresponders to topical steroid treatment prior to inclusion are eligible for the trial. A total of 68 participants will be randomly allocated via a 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 by blinded assessors at 4 timepoints: baseline, 6 weeks, 6 months, and 12 months. The primary outcome is the clinical scoring system for LS-the total LS score.
Recruitment commenced in May 2020 and concluded in November 2023. This study closed in September 2024 due to slow recruitment. Data are being analyzed in 2025, and results are expected to be published in late 2025.
This study will evaluate the safety and efficacy of PRP injections compared to those of saline injections for the treatment of vulvar LS, potentially providing a novel therapeutic option for patients who do not respond to topical steroids.
Australia and New Zealand Clinical Trials Registry ACTRN12618001321235p; Universal Trial Number: U1111-1207-4893; anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375536.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/68871.
外阴硬化性苔藓（LS）是一种慢性复发性皮肤病，通常影响绝经后女性的肛门生殖器区域，不过它可影响任何年龄和性别的人群。目前的金标准治疗方法是终身外用类固醇以减轻症状并防止疾病进展，但这会导致外阴组织发生不可逆的结构改变。LS与生活质量下降及外阴肿瘤形成风险增加相关。临床医生和患者都非常希望有当前治疗方法的替代方案。富血小板血浆（PRP）是一种自体血液制品，含有高浓度的血小板和生长因子，据推测可促进伤口愈合。在一些病例报告和非对照试验中，PRP已被报道可改善LS的症状。
本研究旨在评估PRP与生理盐水注射相比，改善LS临床体征和症状的疗效。
这是一项为期12个月的单中心、平行组、双盲、随机对照试验方案，评估PRP与生理盐水相比治疗LS的疗效。经活检证实患有LS的成年女性患者，身体健康，但在纳入研究前对局部类固醇治疗无反应，符合试验条件。总共68名参与者将通过随机数字生成器随机分配，接受PRP或生理盐水注射到患有LS的外阴区域。所有参与者对所接受的干预措施均不知情。参与者将在4个时间点接受盲法评估者对LS临床体征、主观症状评分和生活质量问卷的随访评估：基线、6周、6个月和12个月。主要结局是LS临床评分系统——LS总分。
招募工作于2020年5月开始，2023年11月结束。由于招募缓慢，本研究于2024年9月结束。数据正在2025年进行分析，结果预计于2025年底发表。
本研究将评估PRP注射与生理盐水注射治疗外阴LS的安全性和疗效，可能为对局部类固醇无反应的患者提供一种新的治疗选择。
澳大利亚和新西兰临床试验注册中心ACTRN12618001321235p；通用试验编号：U1111 - 1207 - 4893；anzctr.org.au/Trial/Registration/TrialReview.aspx?id = 375536。
国际注册报告识别码（IRRID）：DERR1 - 10.2196/68871。
