Extrait

Background and study aims Erosive lichen planus affecting the vulval area causes painful ulcers which last for a long time and are difficult to treat. Very little research has taken place into treatments for erosive lichen planus affecting the female external genital area (vulva) and it is not clear which is the best treatment for people who have severe disease. To find that out, this study compares three most commonly used tablets against an ointment and a short course of steroid tablets. The tablets 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. Who can participate? Adult patients with vulval erosive lichen planus that has not responded well to standard treatment with creams and ointments. What does the study involve? Participants are randomly allocated to take one of the four treatments, although some of the treatments require additional tablets to be taken alongside them to prevent side effects. Participants are able to use a moisturising cream and strong steroid ointment alongside the tablet treatment. They are given the treatment for 6 months at first, 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 is made between the participant and their hospital consultant. What are the possible benefits and risks of participating? There are no guaranteed direct benefits because it is not known for sure that the medications help but the information from this study may help to guide doctors in how patients should be treated in the future. Because this study is comparing four commonly used treatments and the study is designed to mimic normal care, there are no additional risks to participants in taking part in this study. The care that participants receive is very similar to the care that they would receive if they were not taking part in the study. Participants are closely monitored as part of their usual care. Where is the study run from? The study is run from certain hospital departments in the UK that specialize in treating vulval skin disorders. When is the study starting and how long is it expected to run for? June 2014 to April 2016 Who is funding the study? The National Institute for Health Research (NIHR) (UK) Who is the main contact? Dr Rosalind Simpson [email protected]

Critère d'inclusion

• Topic: Dermatology; Subtopic: Skin (all Subtopics); Disease: Dermatology

Liens

• isrctn
• ictrp