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New drugs trial for serious blister disease

   
   
27 Jun 2008 00:00:00.000

PA139/08

It's itchy, very painful and potentially fatal but a new clinical trial by University of Nottingham scientists is hoping to give sufferers of a rare skin condition a safe and effective treatment at last.

Bullous Pemphigoid (BP) is a serious skin disease which leaves elderly people covered in large skin blisters, at risk of infection and, in around 40% of cases, death. Currently treatment is by oral steroids. Although steroids are usually very effective at getting rid of the blisters, their long term use can have serious side effects like high blood pressure, diabetes, osteoporosis and infections.

But now researchers have been awarded nearly £800,000 to fund an international clinical trial of the effectiveness and safety of a simple oral antibiotic and anti-inflammatory drug, doxycycline.

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This antibiotic is a member of the tetracycline family, and previous reports have suggested that tetracyclines may work for pemphigoid but with far less risk of serious side effects.

The five year-long ‘BLISTER’ Study is being coordinated at the University of Nottingham by Professor of Dermatology, Hywel Williams, in collaboration with Professor Fenella Wojnarowska from the University of Oxford who is an expert on blistering diseases. Professor Williams and his team are seeking 250 bullous pemphigoid sufferers in the UK and Germany to take part in the randomised trial in which half will be treated with the current standard steroid drug prednisolone and half with the doxycycline. Each volunteer will be monitored for a year to see whether doxycycline works as well as prednisolone, but with fewer side effects.   

Reacting to the substantial financial award of £796,770 from the National Institute for Health Research Health Technology Assessment (NIHR HTA) programme Professor Williams said,

“It is wonderful that the NHS has not turned its back on elderly people with pemphigoid just because it is a less common condition. Pemphigoid can be a serious disease, and telling a family member that we don’t know how best to treat it because it is rare is of little comfort. If tetracyclines turn out to be useful for people with pemphigoid, then this could have huge implications for the way it is managed in developed and developing countries since the medicine is widely available at low cost.”

Bullous pemphigoid is an autoimmune disease which mainly affects people over sixty and is more common in the over 80s, and is on the increase in the UK. It happens when the immune system starts to malfunction and makes antibodies which attack the membrane between the top layer of skin, the epidermis, and the dermis underneath. Itchy patches appear and then tight, watery or blood-filled blisters which leave skin raw and sore when they burst, and open to infection. It’s quite rare, affecting seven in a million people, yet mortality rates remain the same now as they were sixty years ago.

The BLISTER Study investigators will note each participant’s condition before the course of drugs and monitor any changes or improvements after six weeks. For the important safety data, they will also record and monitor any side effects for a year after starting the trial.

Trial website: http://www.ukdctn.org/ongoing/blister/

NB Professor Williams may be able to provide a case study (BP sufferer) for interview/photographs/filming.

This project was funded by the NIHR Health Technology Assessment programme (project number 06/403/51).

The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Department of Health.

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Notes to Editors: The University of Nottingham is ranked in the UK's Top 10 and the World's Top 70 universities by the Shanghai Jiao Tong (SJTU) and Times Higher (THES) World University Rankings.

It provides innovative and top quality teaching, undertakes world-changing research, and attracts talented staff and students from 150 nations. Described by The Times as Britain's "only truly global university", it has invested continuously in award-winning campuses in the United Kingdom, China and Malaysia.
 
Twice since 2003 its research and teaching academics have won Nobel Prizes. The University has won the Queen's Award for Enterprise in both 2006 (International Trade) and 2007 (Innovation — School of Pharmacy).
 
Its students are much in demand from 'blue-chip' employers. Winners of Students in Free Enterprise for four years in succession, and current holder of UK Graduate of the Year, they are accomplished artists, scientists, engineers, entrepreneurs, innovators and fundraisers. Nottingham graduates consistently excel in business, the media, the arts and sport. Undergraduate and postgraduate degree completion rates are amongst the highest in the United Kingdom.

Story credits

 

More information is available from Professor Hywel Williams, Professor of Dermato-Epidemiology on +44 (0)115 823 1048, hywel.williams@nottingham.ac.uk, Jo Chalmers, Clinical Trials manager on +44 (0)115 846 8622, jo.chalmers@nottingham.ac.uk

Emma Rayner

Emma Rayner - Media Relations Manager

Email: emma.rayner@nottingham.ac.uk Phone: +44 (0)115 951 5793 Location: University Park

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