None listed
Conditions
Brief summary
This is a randomised control trial to compare platelet-rich plasma (PRP) against placebo (normal saline) as a treatment for women with symptomatic vulval lichen sclerosus (LS). LS is an acute and often chronic inflammatory dermatosis with autoimmune pathogenesis (Neill et al., 2010). It is a debilitating condition with serious consequences for the patient’s physical, emotional and sexual health (Newman et al., 2015). The management of LS is aimed at controlling symptoms, mainly severe vulvo-vaginal pruritus. Some women with LS are either unresponsive to corticosteroids or hesitate to use them. There are small studies to demonstrate PRP can improve vulvar LS. Therefore, this study is to assess the efficacy of PRP for treatment of vulvar LS.
Interventions
Arm 1 - Platelet-rich plasma (PRP) is an autologous blood product that will be used to inject into the vulva at the lichen sclerosus lesion. PRP is the study treatment.
Arm 2 – Normal saline will be used to inject into the vulva at the lichen sclerosus lesion as a placebo in this trial.
Informational materials will be the Participant Information and Consent form. The principal investigator will deliver the intervention and placebo treatment. Participants will have two treatments 6 weeks apart
Arm 1 - Platelet-rich plasma (PRP) is an autologous blood product that will be used to inject into the vulva at the lichen sclerosus lesion. PRP is the study treatment. Arm 2 – Normal saline will be used to inject into the vulva at the lichen sclerosus lesion as a placebo in this trial. Informational materials will be the Participant Information and Consent form. The principal investigator will deliver the intervention and placebo treatment. Participants will have two treatments 6 weeks apart at FBW Gynaecology Plus. Assessment is at 6 weeks, 6 months, and 12 months. The first visit is for initial assessment and randomization into the study. The first treatment may occur at the time of the initial assessment. A second treatment will be 6 weeks after the first treatment. The injections into the vulva will be a maximum of 4 mls of PRP or placebo. It may be less if it becomes evident through visual inspection that the tissue cannot hold the maximum amount. Subsequent clinical reviews will be at 6 months and 12 months after the first treatment.
Sponsors
Dr Fariba Behnia Willison
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
a) Are female patients over the age of 18; b) Have been formally diagnosed with lichen sclerosus; c) Remain symptomatic from vulvar lichen sclerosus despite topical steroid treatment prior to the beginning of the study or women who are unable to use or are intolerant of topical steroid use; d) Understand the conditions of the study fully and are willing to participate for the length of the study in its entirety; e) Are capable of, and have given, informed consent to their participation in the study.
Exclusion criteria
a) Patients on anti-oestrogens. b) Patients on systemic immunosuppressant within 12 weeks prior to participating in the study. c) Patients currently suffering any gynaecological or breast cancers. d) Patients with autoimmune disorders requiring anti-platelet medication, except Sjogren’s syndrome and lichen sclerosus. e) Patient who are immunocompromised (e.g. lymphoma, AIDS) or have uncontrolled malignant disease. f) Patient who have been diagnosed with lichen planus, psoriasis, candidiasis, vulvar intraepithelial neoplasia, or vulvar carcinoma. g) Patients with vulvodynia. h) Patients with acute vaginal infection or systemic infection. i) Patients on anti-platelet treatment. j) Patients on aspirin. k) Patients who have a mental disability leading to their inabilty to give consent. l) Patients who are pregnant. m) Patients who are uncooperative, known to miss appointments, are unlikely to follow medical instructions, or unable to attend regular scheduled visits.
Outcome results
None listed