Centre of Evidence Based Dermatology
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hELP Trial 

Overview

The 'hELP' Study is a clinical trial involving women with erosive lichen planus affecting the vulval area. The study was designed to evaluate the effectiveness of tablet treatments for women who had moderate or severe vulval erosive lichen planus that had not responded to treatment with topical ointments or creams. The study started in spring 2014 and closed to recruitment on 31st July 2015.

The hELP trial is being led by Dr Ruth Murphy, a Consultant Dermatologist, and Professor Kim Thomas from the Centre of Evidence Based Dermatology at the University of Nottingham. It is coordinated and managed by Dr Rosalind Simpson at the Centre of Evidence Based Dermatology.

hELP-Trial-logo-resized

 

Latest news

The hELP Study is now closed to recruitment. We are pleased that 22 participants have been entered into the study. Follow up will be complete by August 2016. The study results will be published on this page when they are available.

 
 

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.

More publications

Outcome measures for vulval skin conditions: a systematic review of randomized controlled trials Br J Dermatol. 30 August 2013. doi:10.1111/bjd.12391.

Considerations for disease impact and outcome measures in vulvar disease Journal of lower genital tract disease. October 2012. doi: 10.1097/LGT.0b013e3182449bc1

Real-life experience of managing vulval erosive lichen planus: a case-based review and U.K. mulicentre case note audit Br J Dermatol. 6 June 2012. doi: 10.1111/j.1365-2133.2012.10919.x.

Is vulval erosive lichen planus a premalignant condition? Arch Dermatol. November 2012. doi: 10.1001/2013.jamdermatol.84. 

Vulval erosive lichen planus: a qualitative investigation of U.K. clinician views and principles of management Br J Dermatol. 8 July 2013. doi: 10.1111/bjd.12373

 

 

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).

 

Disclaimer

This website presents independent research funded by the NIHR. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.

This study has been developed with the help and support of the UK Dermatology Clinical Trials Network (UK DCTN). Based at the University of Nottingham, the UK DCTN is a collaborative group of over 700 dermatologists, nurses, primary care staff, health care researchers and patients/carers. The aim of the Network is simple - to develop independent, high quality randomised controlled clinical trials of interventions for the treatment or prevention of skin disease. For further information please see the UK DCTN website.

 

 

Centre of Evidence Based Dermatology

The University of Nottingham
King's Meadow Campus
Lenton Lane
Nottingham, NG7 2NR


telephone: +44 (0) 115 823 1048
email:cebd@nottingham.ac.uk