First use of cord blood platelet-rich plasma in the treatment of vulvar lichen sclerosus: a preliminary study towards a randomized controlled trial

Background: Although topical corticosteroids (TCS) represent first-line treatment for vulvar lichen sclerosus (VLS) and as such should be prescribed to all women at time of diagnosis, approximately 30% of patients do not experience complete symptom resolution following such treatment. TCS may not effectively improve vulvar trophism and elasticity, both of which are crucial for sexual function. Owing to its regenerative and healing properties, cord blood platelet-rich plasma (CB-PRP) may represent an efficacious supplementary therapy, to be administered following first line treatment with TCS. The primary aim of this study was to assess safety and tolerability of CB-PRP in women with VLS. Materials and methods: This is a pilot study which precedes a randomized controlled trial of CB-PRP vs placebo in women with VLS. Ten consecutive patients with VLS, who had previously undergone standard TCS-treatment, received three vulvar CB-PRP injections monthly. Follow-up was conducted three months after the last injection using vulvoscopy and validated questionnaires to evaluate safety and tolerability, as well as patient satisfaction, symptom improvement, sexual function, psychological well-being, quality of life, frequency of TCS application as a maintenance treatment, vulvar trophism and architectural modifications. Results: No adverse clinical effects were observed. Five patients (50%) were either satisfied or very satisfied with the procedure, four (40%) were uncertain about their satisfaction with the treatment. One patient (10%) dropped out for personal reasons and was classified as unsatisfied according to an intention-to-treat analysis. At follow-up median numeric rating scale scores were significantly reduced for vulvar burning compared to baseline (p<0.05) there was a trend toward improvement in itching, dyspareunia, and dysuria. A significant improvement in sexual arousal and satisfaction was observed in all treated women (p<0.05). Discussion: CB-PRP may be a promising treatment for VLS. It appears to be safe and improve symptoms and sexual function.