Evaluation of Fat Grafting to treat Vulvar Lichen Sclerosus
Research type
Research Study
Full title
Evaluation of Fat Grafting to treat Vulvar Lichen Sclerosus
IRAS ID
170636
Contact name
Peter Butler
Contact email
Sponsor organisation
UCL
Clinicaltrials.gov Identifier
15/0753, Applicants organisation own reference number
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Lichen Sclerosus is chronic inflammatory disorder of the skin which affects about 1 in 1,000 women in UK. Some of the physical effects of LS include pruritus (chronic itching), dysuria (painful urination) and vaginal discharge. Other symptoms include the narrowing of the inotroitus, dyspareunia, vulvodynia, difficulty achieving orgasm and as a result a loss of interest in sexual activity. Engaging in sexual intercourse can lead to traumatic fissures and tears. Research shows that the physical impact of LS in women can have a detrimental effect on psychological well-being. Recently, autologous fat transfer has been introduced as additional therapeutic option in patients non-responders to steroids, and remarkable improvements in both function and quality of fibrotic skin have been reported. However, existing clinical research is limited by a lack of experimental data that quantifies the outcome. In fact, previous studies draw conclusions based on subjective, imprecise outcome measures, making statistical evaluation difficult and potentially introducing bias.
In this study, we aim to use a variety of non-invasive techniques to objectively assess the quality of fibrotic skin and patients’ quality of life in response to fat grafting. Patients who will undergo lipotransfer at the Royal Free Hospital will be evaluated using different methodologies. Firstly, we will perform a physical assessment to evaluate the patient’s baseline clinical status. Secondly, ultrasound will be used to assess blood flow and tissue viability in the reconstructed organs. Questionnaires will be provided to assess the healing from the patient’s perspective. Images (2D, 3D, and thermal) will be undertaken to monitor the outcome. All investigations will be repeated following treatment. The information gained from this study will improve our knowledge of the efficacy of fat graft treatment for LS, allowing us to improve our reconstructive surgical techniques and provide better outcomes for patients requiring these types of reconstructive surgeries.
The surgery aspect is not part of the research study.REC name
London - Hampstead Research Ethics Committee
REC reference
16/LO/1980
Date of REC Opinion
25 Nov 2016
REC opinion
Further Information Favourable Opinion