dermatology research team - making research real · page 1 of 10 working in partnership with the...
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Working in partnership with the National Institute for Health Research Clinical
Research Network
Dermatology Research Team
L to R (Top to Bottom): Professor Andrew Wright, Dr Miriam Wittmann, Dr Susanne Hatfield, Sister Ellie Angelova, Sister
Jenny Ott, Sister Annette Essex.
Contents:
Who We Are ........................................................................................................... 2
Mission Statement .................................................................................................. 2
How We Promote and Implement High Quality Research ...................................... 2
Previous Research ................................................................................................. 3
Current Research ................................................................................................... 3
Industry Partners .................................................................................................... 5
Achievements ......................................................................................................... 5
Meet the Team ....................................................................................................... 7
Contact Us .............................................................................................................. 9
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Who We Are
We are part of the Bradford Teaching Hospitals NHS Foundation Trust (BTHFT)
The Dermatology Research Unit was established in 2009 by Professor Andrew Wright and
Jenny Ott (Research Nurse). Recruitment to trials, began right from the start and to date the
team have been involved in and completed numerous portfolio and commercial trials. The
team has good links with the Bradford Centre for Skin Sciences, Nottingham Clinical
Trials unit, Born in Bradford and the Bradford University Ethical Tissue Bank. We have
also worked with Covance thus helping in the early stages in developing new medications
and treatments.
Mission Statement
We are a motivated team, dedicated to the improvement of patient therapy and care within
Dermatology. We aim to support key academic research in conjunction with the Centre for
Skin Sciences, BIHR and Ethical Tissue Bank at Bradford University. We endeavour,
through our research to provide high quality clinical data by meeting our recruitment targets
and ensuring that all documentation is accurate and reliable.
How We Promote and Implement High Quality Research
Our research facility is based at St Luke’s Hospital where we have a small, but well equipped, dedicated room with centrifuge, black-out curtains and a -20°C freezer. We are also supported by the hospital pharmacy.
All members of the team ensure that they are compliant with The Trust mandatory training programmes as well as being GCP trained. Relevant clinical training for each trial is strictly adhered too, and additional training/education is undertaken on an individual basis according to trial/role demand.
We embrace the ethos of quality data collection and information governance processes.
Through the NIHR, the government has committed to working with the life sciences industry to deliver first class clinical research in the NHS. To achieve this, the NIHR is funded to manage a broad research infrastructure including expert individuals, research facilities and technology platforms.
In support of the life sciences industry, the NIHR provides dedicated teams through which companies have a direct route to work with the country's leading investigators, research facilities and technology platforms. For more information, go to the NIHR website at http://www.nihr.ac.uk/industry/
The local point of contact for the NIHR CRN Yorkshire & Humber is the Industry Manager at
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Previous Research
Our main research areas have included:
• Treatment Trials for Psoriasis
• Registry for Biologics Treatment
• Treatment Trials for Eczema
• Treatment Trials for Pyoderma Gangrenosum
• Treatment Trials for Vitiligo
• Treatment Trials for severe hand eczema
• Commercial Trials for the beauty industry
• Skin Cancers Ethical Tissue Banking
• Melanoma Lifestyle studies
• National and local epidemiological studies and audits
And collaborating with Bradford University studies in:
• Frontal Fibrosing Alopecia
• Alopecia Areata
• Human Hair Follicle
• Genomic & Environmental influences in Skin
• Skin cancer
Impact of Research on Patient care:
• Improving patient outcomes in trialling novel agents
• Closer clinical monitoring, leading to better care
• Free access to treatment & medication whilst on trial
• Better informed about their skin disorders
• Leading to Better Quality of Life
Current Research Trials
At present we are undertaking several trials –
ALPHA : severe hand eczema. This is a trial on which Dr Miriam Wittmann is the chief
investigator. The trial is a comparison of two standard treatments, Alitretinoin 30mg daily and
PUVA. This trial should unlock various questions to what is a very debilitating illness for
patients.
BADBIR: Patients that start new systemic or biologic treatment for their severe psoriasis are
asked to join a national register. The purpose of this register is so that a large cohort of
patients can be monitored long-term on their respective biologic therapy. Data is entered on
a regularly basis about various aspects of the patients well- being such as quality of life,
depression and current treatment questions.
BStop: In conjunction with other hospitals this is a psoriasis study which is a prospective
cohort study to establish relevant pharmaco-genetic markers of systemic treatment
outcomes. Patients donate blood samples at regular intervals for a period of over 5 years
and sent to Kings College London as the co-ordinating centre. Recruitment is on-going and
so far we have had over 125 patients donating blood.
CLEAR: Psoriasis study for patients who have failed other systemic treatments. This is a
double-blinded, multicentre, randomised study using secukinumab compared to
ustekinumab –with a primary endpoint of achieving PASI 75 at 16 weeks.
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Ethical Tissue collection: In conjunction with the University of Bradford and Skin Sciences
unit we are currently collecting blood and tissue from patients with illnesses such as
Alopecia Areata, Vitiligo, keratoacanthomas and large skin cancers.
HELP: Erosive Lichen Planus is a chronic inflammatory skin condition that affects
predominantly the mucosal surfaces on the mouth or/and genital region. This is a four-arm ,
open-label trial comparing systemic treatments for LP.
HILIGHT: This is a 3 arm blinded study of vitiligo treatment where patients are randomised
to use a moderate steroid and UVB light treatment with photographs and self assessment at
periods throughout the trial
IMAP: In conjunction with the Psoriasis Association and Manchester University we are
participating in a longitudinal study of adherence to medication in people living with
psoriasis. As psoriasis is a chronic inflammatory skin condition associated with considerable
physical and psychological impact patients are asked to fill in questionnaires about what they
think and fell about their medication. This is a multi-centre study to which we have over 40
patients contributing.
ACTINIC KERATOSIS: This is a multi-centre, randomised 2 arm, open label, 36 month
phase IV trial for patients with multiple actinic keratosis on the face or scalp. The main
purpose of this trial is comparing the incidence of SCC after using Ingenol Mebutate or
Imiquimod on the scalp. Bradford was the centre to recruit the first patient.
SIGNATURE: Psoriasis phase III study with patients who have moderate to severe chronic
plaque psoriasis who have failed on TNFa antagonists which is designed to prove and
qualify that secukinumab is safe and well-tolerated .The primary object is to achieve a PASI
75 response after 16 weeks on 300mg. This is an open-label study and we have achieved
our recruitment target.
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Industry Partners
We have a range of experience of working on commercial and industrial drug trials focusing
on dermatological conditions. We have also successfully facilitated CTIMP (Clinical trials for
Investigative Medicinal products) for a variety of pharmaceutical companies. Our previous
clients include
Novartis - an international company based in Switzerland- we are building a relationship
with Novartis where they can use our facilities repeatedly for their studies because of our
previous success.
LEO Pharma Founded in 1908 - is based in Denmark and manufactures and markets drugs
for dermatological conditions. We have successfully undertaken to commercial trials with this
company
L’Oreal has a unique portfolio of international brands founded by Eugène Schueller in 1909
has become the number one cosmetics group in the world.
Thornton and Ross is owned by Frankfurt based STADA Arzneimittel AG. Thornton & Ross
has become the Centre of Excellence within the STADA group in order to promote the
development of OTC and Dermatology business
Nottingham Clinical Trials Unit -NCTU works in collaboration with clinicians and
researchers to design and conduct high quality multicentre randomised trials addressing
important health questions - we have worked with NCTU on multiple occasions
Collaborative Work - we work and liaise with the Centre for Skin Sciences at the University
of Bradford to facilitate high level academic research into skin disorders, particularly skin
cancer and vitiligo. We are proud to support their academic research by providing tissue,
blood and hair samples.
MeDALL - Mechanisms of the Development of ALLergy. We were also very please to be
involved in the MEDALL study which is part of the Born in Bradford research project; this is
an epidemiological study of children born in Bradford from 2007 until 2010. The information
gathered for this long term study will help to find the common causes of come childhood
illnesses and will explore the mental health and development over the coming years. Our
role in this was to visit around 400 children where, via a questionnaire, parents had stated
their child had an itchy rash. A SCORAD assessment was done on the skin of the children
and we also bolted on more dermatological questions to add to the data to enable us to have
a better understanding on children in Bradford with atopic dermatitis.
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Achievements
Our team is proud of the increasing number of trials that we have been involved and have
been successful in achieving our recruitment targets.
Success in global First patient First Visit
First Patient First Visit – is a major achievement for a portfolio study. We achieved this
within one year of expanding our nursing team and have done this again with the ALPHA
trial
Consistent High Patient Recruitment and Retention - Recruiting patients in specialist
areas is a challenge and can be time consuming. There are stringent targets to be met from
the NHS and we have successfully maintained these targets on a regular basis and have
even over recruited to certain projects.
Spreading The Word – we regularly submit a newsletter to all the General practitioners in
Bradford with a special interest in dermatology (GPSI). The newsletters give information
about all the trials we are currently undertaking and how they are progressing. We regularly
have meeting and our research presence is contributed so that we can optimise our
recruitment targets. We have also used the hospital magazine to advertise for recruits.
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Meet the Team
Professor Andrew Wright
Consultant Dermatologist
Professor Wright is the Senior Dermatologist at Bradford Hospitals and Lead Clinician for Dermatology Research, as well as Skin Cancer at the Hospitals Trust. He is an Honorary Visiting Professor at Bradford University and a member of the Centre for Skin Science at Bradford University. His particular areas of interest are skin cancer, eczema and skin allergy.
Dr Miriam Wittmann
Honorary Specialist Doctor in Dermatologist
Dr Miriam Wittmann is an Associate Professor in Inflammatory Skin Diseases at the University of Leeds, Honorary Specialist Doctor in Dermatology. Her main interests are in Chronic inflammatory skin diseases in particular Psoriasis, Psoriatic Arthritis and Eczema.
Dr Susanne Hatfield
Staff Grade Doctor in Dermatology
Dr Hatfield has a special interest in paediatric dermatology and genodermatoses. She has recently joined the research team on a part-time basis. She is a current holder of a UKDCTN SAS award. This has given her the opportunity to attend UKDCTN (UK Dermatology Clinical Trials Network) steering committee meetings, this committee looks at developing research ideas into fully funded clinical trials. This has also given her access to further training based at the Centre for Evidence-Based Dermatology in Nottingham and develop a better understanding of research in Dermatology.
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Jenny Ott
Research Nurse
Jenny is a registered nurse and has a varied
medical nursing background, including general
medicine, infectious diseases, and renal
medicine. Jenny also worked on the
dermatology ward many years ago and since
2009 has worked as a part-time research nurse.
Jenny enjoys a varied role from recruitment to
patient care, embracing all aspects of the role.
Annette Essex
Research Nurse
Annette is a registered nurse and also has a varied medical nursing background, including general medicine, renal, gastroenterology and dermatology. Annette worked on the dermatology unit before undertaking a part-time research nurse role in 2015. Annette has particular IT skills and enjoys data collection whilst maintaining direct patient contact.
Tsvetely Angelova
Research Nurse
Tsvetely has completed fast track nursing programme in Homerton college, Cambridge before moving to Nottingham in 2005. In 2009 she started her first research job as a Senior Research Nurse in Hepatology. Since then she has been continually engaged in research in various specialities and research has become a passion for her. Between 2006 and 2010 she also completed two Masters degrees – Health Promotion (UCL, London) and Psychology (Manchester University).
Ahmaad Bashir
Research Administrator
Ahmaad has recently joined the team as the Research Administrator. Prior to this post he has held various positions within the NHS in both clerical and caring settings. He has a BSc Information Management for Business from University College London, with a strong background in Finance. He is also currently studying medicine at Durham University.
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Recent published work from our research team
1. A randomized control trial of a 4% cutaneous emulsion of sodium chromoglycate in treatment of atopic dermatitis in children. Berth-Jones J, Pollock I, Lewis-Jones S Wright A et al. Journal of Dermatological treatment 2014 in press
2. Sun awareness education and photo protective behaviour in immunosupressed renal disease patients: a questionnaire to assess knowledge and practices Wright J, Wright A, Hewins P. Abstract British journal of dermatology 171 2014 supplement 1 p111
3. Sensitivity and specificity of the empirical lymphocyte genome sensitivity (LGS) essay: implications for improving cancer diagnosis Andreson D et al FASBED journal fj 14-254748 2014
4. Seltmann J, Roesner LM, von Hesler FW, Wittmann M, Werfel T. IL-33 impacts on the skin barrier by downregulating the expression of filaggrin. J Allergy Clin Immunol. 2015;135:1659-1661.
5. D´Erme AM, Wilsmann-Theis D, Wagenpfeil J, Hölzel M, Ferring-Schmitt S, Sternberg S, Wittmann M, Peters B, Bosio A, Bieber T, Wenzel J. IL-36γ (IL-1F9) is a biomarker for psoriasis skin lesions. J Invest Dermatol, 2015; 135:1025-1032.
6. Doble R, McDermott MF, Cesur O, Stonehouse NJ, Wittmann M. IL-17A RNA Aptamer: Possible Therapeutic Potential in Some Cells, More than We Bargained for in Others? J Invest Dermatol. 2014; 134:852-5.
7. Muhr P, Zeitvogel J, Heitland I, Werfel T, Wittmann M. Expression of IL-1 family members upon stimulation with IL-17 differs in keratinocytes derived from psoriasis patients and healthy donors. Br J Dermatol. 2011; 165:189-93
8. Renne J, Schäfer V, Werfel T, Wittmann M: IL-1 from epithelial cells fosters T-cell dependent skin inflammation. Br J Dermatol, 2010; 162:1198–1205
9. Wang D, Drenker M, Eiz-Vesper B, Werfel T, Wittmann M: Evidence for a pathogenetic role of interleukin-18 in cutaneous lupus erythematosus. Arthritis Rheum. 2008; 58:3205-15
10. Renne J, Werfel T, Wittmann M: High frequency of vitamin D deficiency among patients with cutaneous lupus erythematosus. Br J Dermatol. 2008;159:485-6.
11. Wittmann M, McGonagle D, Werfel T. Cytokines as therapeutic targets in skin inflammation. Cytokine Growth Factor Rev 2014, 25:443-51
12. Wittmann M, Helliwell PS. Phosphodiesterase 4 inhibition in the treatment of psoriasis, psoriatic arthritis and other chronic inflammatory diseases. Dermatol Ther (Heidelb). 2013; 3:1-15
13. Alase A, Wittmann M. Therapeutic strategies in Allergic Contact Dermatitis. Recent Patents on Inflammation & Allergy Drug Discovery, 2012; 6(3):210-21
14. Wittmann M, Goodfield M: Cytokines in Cutaneous Lupus Erythematosus. Expert Rev Dermatology 2011, 6:381-394
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Contact Us
Interested in getting involved with dermatology research?
Contact our team in the first instance:
P: 01274 375456
: @DermResearchBTH
Find out more about our facilities:
Our Research Website is www.bradfordresearch.nhs.uk
Interested in learning more about local research, support and facilities
available in Yorkshire and Humber?
Official NIHR CRN Website and Industry is http://www.nihr.ac.uk/industry/