Platelet-Rich Plasma Versus Saline for the Treatment of Vulvar Lichen Sclerosus: Protocol for a Randomized Controlled Trial

Several human studies show positive signals, while research methods and sample sizes continue to develop.

• Level A · Stronger Clinical Evidence
• Level B · Emerging clinical evidence with positive signals
• Level C · Early human research exploring benefits
• Level D · Scientific groundwork from lab and animal studies
• Emerging · Emerging topic under active research

Abstract (original English)

Background 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. 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-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 recei

Evidence level

Several human studies show positive signals, while research methods and sample sizes continue to develop.

Browse all related research

Filter the research library by this study's title keywords, author, or publication year.