Key Facts
1. How many trial participants do you need?
We are looking for up to 96 women with vulval erosive lichen planus to take part in the study.
2. Am I eligible to take part?
To take part you will need to have quite bad vulval erosive lichen planus. That means that the condition has not responded well to standard treatment with creams and ointments. You must be willing to take a tablet treatment to help try and improve your condition. All people who join the study must be over 18 years of age.
3. What treatments are you testing?
We are comparing four different tablet treatments to see how well they work for vulval erosive lichen planus. You will only be asked to take ONE of the four treatments, although some of the treatments require additional tablets to be taken alongside them to prevent side effects. You will be able to use a moisturizing cream and strong steroid ointment alongside the tablet treatment.
The four tablets we are testing all fine tune, or dampen the body's immune system. This is because an overactive immune system is thought to be the cause of erosive lichen planus.
4. How long will the study last for?
Overall, the study will last for two years, from June 2014 - April 2016. Each person will take part in the study for 12 months. They will be given the trial treatment for six months initially, after which time it can be continued if it has been effective. If it has not been effective, treatment can be changed. This is a decision that will be made between yourself and your hospital consultant.
5. How is the study funded?
The study has been funded by the National Institute for Health Research through a Doctoral Research Fellowship Award.
How to get involved
List of recruiting centres: click here
Patient information sheet
If you have a diagnosis of erosive lichen planus affecting the vulval area and think you might be interested in participating in this study, please first read the information on this website carefully. We would then advise speaking with the doctor who looks after your vulval condition to see if they are due to be involved in the study.
Alternatively you can contact the research team for further information.
Contact
Trial Manager: Dr Rosalind Simpson,Clinical Research Fellow, Centre of Evidence Based Dermatology, University of Nottingham
Email: helpstudy@nottingham.ac.uk
Publications
Diagnostic criteria for erosive lichen planus affecting the vulva: an international electronic-Delphi consensus exercise Br J Dermatol. 13 August 2013. doi: 10.1111/bjd.12334.
For researchers
Current documents for use by sites. (N.B. These are controlled documents. The content cannot be changed except for site specific details which are highlighted. Please contact the trial manager with any queries).