The PETALS trial
Research type
Research Study
Full title
PlatElet-rich plasma and Autologous lipotransfer to treat vulval fibrosis in Lichen Sclerosus - the PETALS multicenter randomized controlled feasibility trial
IRAS ID
333113
Contact name
Tolu Williams
Contact email
Sponsor organisation
Royal Free London NHS Foundation Trust
Duration of Study in the UK
2 years, 10 months, 1 days
Research summary
Vulval lichen sclerosus (VLS) is an itchy skin condition affecting the entrance to the vagina (vulva). In severe cases, it causes scarring and fusion of parts of the vulva, leading to painful skin tears, difficulty in having sex and going to the toilet. It is most diagnosed before puberty and after menopause.
Treatment includes lifelong use of creams that reduce skin inflammation (angriness) called steroids. For most patients the condition is controlled by this treatment but some experience ongoing symptoms, scarring and skin thickening.
Recent studies have introduced two potential surgical treatments: fat grafting and platelet-rich plasma (PRP) which may improve VLS symptoms and reduce scarring.Fat grafting involves collecting fat from the patient’s own body and injecting it into the vulva. PRP is obtained from the patient's blood, prepared in a special way, and then injected into the vulva.
This pilot study aims to establish if fat grafting and PRP are acceptable as VLS treatments and how to best measure their effectiveness. We also want to know if a larger trial across multiple hospitals could be conducted in the future to determine if these treatments are effective and can be offered to patients across the UK.
This NIHR-funded (National Institute for Health and Care Research) study will involve 75 women with VLS recruited at the Nottingham University Hospital and Royal Free Hospital, London. They will be allocated randomly and equally into three groups: fat grafting, PRP and steroid cream only. Patients in the surgical groups will undergo one surgery and will continue using the steroid cream. Participants will complete questionnaires about their symptoms, quality of life and sexual function. We will assess improvements by analysing photographs of the vulva and measuring the thickness of the vulval skin using specialised equipment. Patients will be followed up for six months.
REC name
London - Riverside Research Ethics Committee
REC reference
25/LO/0107
Date of REC Opinion
11 Mar 2025
REC opinion
Further Information Favourable Opinion