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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Rosalind Simpson
-
rosalind.simpson@nottingham.ac.uk


Dr PEARLS Study Team
-
PEARLS@nottingham.ac.uk


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Be Part of Research - Trial Details - Proactive against reactive treatment for lichen sclerosus
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Proactive against reactive treatment for lichen sclerosus

Recruiting

Open to: Female

Age: Mixed

Oxford Blackburn Aberdeen London Nottingham Derby Middlesbrough Leicester Redhill Gateshead Manchester Derby Telford Liverpool Liverpool London

Medical Conditions

Vulval lichen sclerosis

This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.


Lichen sclerosus (LS) is a long-term, itchy and distressing condition affecting vulval skin (the skin around the outside of the vagina). It needs ongoing treatment with steroid creams to manage flares of symptoms. If untreated, it may lead to scarring causing the labia minora (inner lips) to fuse together or the entrance to the vagina to narrow. People with LS are at higher risk of developing vulval cancer. Vulval LS can affect everyone, but most commonly children and women of any age, particularly women who have gone through the menopause and children before puberty. This study will try to find out what is the best way to manage future flares of LS: using a steroid treatment regularly (e.g. twice a week), even when symptoms are controlled OR using a steroid cream only during a flare.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Apr 2024 01 Sep 2025

Participants are randomly allocated to either use their steroid cream twice a week or to only use it if they experience symptoms. The researchers will compare how many people in each group develop LS flares. With the optional consent of the participant/parent/guardian, photographs will be taken at baseline to check if scarring worsens during the trial. The researchers will follow patients for 2 years to gather data. With participants’ consent (optional), the researchers will check their medical records at a later stage (after the trial ends) to see how many patients in each treatment group develop cancer. They will conduct an optional qualitative study and interview patients (those who consented to participate in qualitative sub-study) to explore how they feel about the trial and the different ways of treating LS that we are testing. The researchers will also compare the costs and outcomes of the two treatments used in the trial to see if one is better value for money for the NHS. If successful, the study results will be used to change clinical practice for the treatment of patients with LS.


Female patients with LS aged 5 years and over

You can take part if:



You may not be able to take part if:


1. Previous vulval intraepithelial neoplasia (VIN) or vulval squamous cell carcinoma (SCC)2. Contraindications to topical steroids3. Concomitant use of other topical anti-inflammatory vulval treatments4. Using systemic immunosuppressants (for any indication) 5. Using systemic treatment for LS6. Patients with surgical alteration of vulval skin as part of gender reaffirming surgery, or patients not born with a vulva7. Pregnant and breastfeeding women


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Churchill Hospital
    Churchill Hospital Old Road Headington
    Oxford
    OX3 7LE
  • Royal Blackburn Hospital
    Haslingden Road
    Blackburn
    BB2 3HH
  • Aberdeen Royal Infirmary
    Foresterhill Road
    Aberdeen
    AB25 2ZN
  • Whipps Cross University Hospital
    Whipps Cross Road Leytonstone
    London
    E11 1NR
  • Nottingham City Hospital
    Hucknall Road
    Nottingham
    NG5 1PB
  • Royal Derby Hospital
    Uttoxeter Road
    Derby
    DE22 3NE
  • The James Cook University Hospital
    Marton Road
    Middlesbrough
    TS4 3BW
  • Leicester Royal Infirmary
    Infirmary Square
    Leicester
    LE1 5WW
  • East Surrey Hospital
    Canada Avenue
    Redhill
    RH1 5RH
  • Queen Elizabeth Hospital
    Sheriff Hill
    Gateshead
    NE9 6SX
  • St Mary's Hospital
    Oxford Road
    Manchester
    M13 9WL
  • Florence Nightingale Community Hospital
    London Road
    Derby
    DE1 2QY
  • Princess Royal Hospital
    Apley Castle, Grainger Drive Apley
    Telford
    TF1 6TF
  • Liverpool Women's Hospital
    Liverpool Womens Hospital Crown Street
    Liverpool
    L8 7SS
  • Axess Sexual Health, Royal Liverpool University Hospital
    Mount Vernon St
    Liverpool
    L7 8XP
  • Market Street Health Centre, Oxleas
    16-20 Market Street Woolwich
    London
    SE18 6QR

The study treatment involves topical steroid ointment/cream, which is normally prescribed to patients as their routine care for LS. The only difference between the study treatment and the routine care may be the treatment regimen. It is, therefore, believed that the risk associated with the study due to the intervention is negligible. Participants will be asked to attend research appointments. Every effort will be made to coincide these appointments with participants' clinical appointments.
Safety data will be collected for the duration of participation and will be reported as per sponsor guidelines. Although the steroid treatment can be safely applied to the whole body in a single dose with minimal risk of adverse reactions, there is however a risk of adverse reactions following long-term use of topical corticosteroid on localised areas of skin (e.g. skin thinning, telangiectasia). These will be monitored during clinical examination at follow-up visits (or at an unscheduled trial visit, as necessary).

Dr Rosalind Simpson
-
rosalind.simpson@nottingham.ac.uk


Dr PEARLS Study Team
-
PEARLS@nottingham.ac.uk



The study is sponsored by Nottingham Clinical Trials Unit and funded by Health Technology Assessment Programme.



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Read full details for Trial ID: ISRCTN72275160

Or CPMS 61122

Last updated 01 August 2024

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