HELP trial (systemic tHerapy for vulval Erosive Lichen Planus)
Research type
Research Study
Full title
A Randomised Controlled Trial of Adjunctive Systemic Therapy for Vulval Erosive Lichen Planus
IRAS ID
128636
Contact name
Kim S Thomas
Contact email
Eudract number
2014-000547-32
Research summary
Erosive lichen planus affecting the vulval area condition causes painful raw areas which last for a long time and are difficult to treat. Very little research has taken place into treatments for this condition and it is not clear which is the best treatment for people who have severe disease. Finding effective treatments will help to reduce symptoms and improve people’s quality of life.
This study will compare four commonly used tablet medicines in the treatment of vulval erosive lichen planus. The tablets that will be compared are 1) Hydroxychloroquine, which helps to ‘fine tune’ the body’s immune system; 2) Methotrexate, 3) Mycophenolate mofetil and 4) Prednisolone, which all calm the body’s immune system. Prednisolone will only be taken for four weeks as it can only be used in short bursts. The other tablets will be taken for at least six months. All participants will use a strong steroid ointment on the affected areas, in conjunction with their tablets.
Patients with severe disease that hasn’t responded to creams and ointments will be considered for this study. It will be a ’randomised controlled trial’ where people will randomly be put into groups and each group will be given a different treatment. There will be a 1 in 4 chance of receiving each of the treatment groups.
Participants will be followed up by the hospital doctor who normally treats their erosive lichen planus. After six months participants can continue to take their treatment if it is working. If not they will be changed to something else. Participants will be contacted after 12 months by the study team to find out how they have been long-term.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
14/YH/0046
Date of REC Opinion
13 Mar 2014
REC opinion
Favourable Opinion