Guy's and St Thomas' NHS Foundation Trust - Children

 Prof. Carsten Flohr (Chief Investigator)

                                                                      

Carsten Flohr studied at Cambridge and Oxford Universities and then trained in both paediatrics and dermatology. He was the first UK National Institute for Health Research (NIHR) Clinician Scientist in Dermatology and was recently awarded a senior Career Development Fellowship from the NIHR.

He is Professor of Dermatology and Population Science and directs the Unit for Population-Based Dermatology Research at St John’s Institute of Dermatology, King’s College London and Guy’s & St Thomas’ NHS Foundation Trust.

He is also Consultant in Dermatology and Research & Development Lead at St John’s Institute of Dermatology.

Prof Flohr has a particular interest in atopic eczema, its causes and novel methods of disease prevention and treatment

Guy's and St Thomas' NHS Foundation Trust - Adults

Professor Catherine Smith

             

Consultant Dermatologist, Honorary Professor of Dermatology and Therapeutics, St John’s Institute of Dermatology, Guy’s & St Thomas’ NHS Foundation Trust. Clinical lead of national specialised service in adult atopic eczema. Expertise in clinical and bioresource data collection (Lead for Guy’s and St Thomas’ NIHR BRC biobanking cutaneous medicine theme; BADBIR Co-Investigator since its inception (2007), Chair (2010-2015) and member of the Steering Committee). PI/Co-Investigator on trials investigating biologics and small molecules in atopic eczema.

Bristol Childrens' Hospital

Dr Louise Newell

            

Consultant Dermatologist, Bristol Royal Infirmary and Bristol Children’s Hospital. Extensive experience in managing severe eczema requiring systemic treatment, in adults and children. Leads dedicated severe eczema clinics for adults and children.

University of Dundee

Dr Sara Brown

             

Professor of Molecular and Genetic Dermatology, Wellcome Trust Senior Research Fellow in Clinical Science, Honorary Consultant Dermatologist, Dundee; specialist clinics for adult and paediatric eczema; research expertise in genetic mechanisms in atopic skin; Steering Committee member of UK TREND (Translational Research Network in Dermatology) and co-lead of research investigating gene-environment interactions in atopic eczema pathogenesis.

University of Edinburgh

Dr Richard Weller

          

Richard Weller, Reader and Honorary Consultant Dermatologist, University of Edinburgh. Runs the eczema clinic in NHS Lothian and is active in basic and clinical research in eczema. Dermatology Lead for NHS Research Scotland. Expert advisor to NICE on dermatology.

Great Ormond Street Hospital

Dr Karolina Gholam

        

Being dually accredited in paediatrics and dermatology puts Dr Gholam in a unique position to look after children with complex skin disorders at Great Ormond Street Hospital. Her special interests are inflammatory dermatoses such as eczema and psoriasis, psychodermatology as well as laser and cutaneous surgery. She has a passion for teaching and lecture regularly on paediatric dermatology related topics to paediatricians and dermatologists in a variety of settings including national and international meetings. Her research interest is in inflammatory dermatoses and in particular psoriasis. She is the principal investigator in a prospective study on the use of Ustekinumab in children and has published in international journals in a variety of paediatric dermatology related topics.

University of Newcastle and Newcastle Hospital NHS Foundation Trust

Professor Nick Reynolds

           

Professor of Dermatology, Newcastle University, with a particular interest in therapeutics. Published one of the first stratified medicine studies in dermatology, a RCT of azathioprine in atopic eczema that utilised pharmacogenetic-based dosimetry. Co-Investigator in BADBIR since its inception, also leads one of the workstreams for PSORT. Director of Newcastle’s EPSRC/MRC Molecular Pathology Node, one of six units established in the UK to develop molecular diagnostic tools for stratification. Inaugural Chair UK TREND (Translational Research Network in Dermatology), now demitted and Past President of the European Society for Dermatological Research (ESDR).

Our Lady's children's Hospital Crumlin (Dublin)

Professor Alan Irvine

                

Professor in Dermatology, Trinity College Dublin and Consultant Dermatologist in Our Lady’s Children’s Hospital/St. James’s Hospital, Dublin, Ireland. His department in OLCHC manages or shares care for >95% of all Irish children on systemic therapy for atopic eczema. Alan has long standing interests in the mechanisms underlying AD and therapeutic approaches to this condition. Since 2013, Alan has led the development of skin registries for the Irish Skin Foundation.

MRC Human Immunology Unit and Oxford University Hospitals NHS Foundation Trust

Dr Graham Ogg

                
Professor of Dermatology, University of Oxford and Honorary Consultant Dermatologist, Oxford University Hospitals NHS Trust. Runs a specialist adult eczema clinic. Deputy Director of the MRC Human Immunology Unit and sub-theme lead for the Oxford NIHR Biomedical Research Centre, which supports basic science and clinic trial work. Longstanding interest in the immunology of atopic eczema, with a particular focus on the roles of innate lymphoid cells and lipid-specific CD1a-restricted T cells, and their impact on the epithelium.

University of Manchester

Professor Christopher Griffiths

                 

Foundation Professor of Dermatology, University of Manchester, and Honorary Consultant Dermatologist, Salford Royal NHS Foundation Trust, >30 years of research experience into inflammatory skin diseases with internationally recognised expertise in their management. Founder of the Dermatopharmacology Unit, University of Manchester. Involved in trials of all new biologics and small molecules in development for atopic eczema. Co-Founder and Chief Investigator of the British Association of Dermatologists Biologic Interventions Register (BADBIR) – gold standard web-based pharmacovigilance for psoriasis with 15,700 registrations.

Royal Children's Hospital Glasgow

Dr Paula Beattie

                  

Dr Paula Beattie is a Consultant Dermatologist in Glasgow and Honorary Senior Lecturer at University of Glasgow. She has a clinical and research interest in Atopic Eczema in both Children and Adults and has been involved in a number of UK wide eczema studies and trials. She sat on the development committee for the NICE guideline for assessment and diagnosis of food allergy in children.

Sheffield Teaching Hospital and Sheffield Children's Hospital

Professor Mike Cork

 

I joined the University of Sheffield in 1991 as a lecturer in dermatology whilst continuing as a practising dermatologist for the NHS in Sheffield. I had previously been a Registrar in Dermatology at the Royal Hallamshire Hospital, Sheffield, and before that a Registrar in Respiratory General Medicine at Leeds General Infirmary.

I have been closely involved with research in many areas of dermatology; including Atopic Eczema(dermatitis), Psoriasis, Vitiligo and the Genetics of Skin Disease. My major current research work is aimed at identifying gene–environment interactions in the development of atopic dermatitis leading to skin barrier breakdown and the understanding of how topical agents interact with the skin barrier; using this information to enhance the treatment of atopic dermatitis.

I am currently Head of Sheffield Dermatology Research in the Department of Infection, Immunity & Cardiovascular Disease at the University of Sheffield Medical School and am Honorary Consultant Dermatologist to both Sheffield Children´s Hospital NHS Foundation Trust and to Sheffield Teaching Hospitals NHS Foundation Trust; my time is evenly split between the University and the NHS.

University of Southampton

Associate Professor Dr Michael R. Ardern-Jones BSc, MBBS, DPhil, FRCP

      

Michael Ardern-Jones (MAJ) trained in Dermatology at St John’s Institute of Dermatology, London and subsequently Oxford. His DPhil (PhD) at Oxford explored the immunology of atopic dermatitis. He was appointed to University Hospitals Southampton NHS Trust and to the Faculty of Medicine, University of Southampton in 2005.

He has a specific academic interest in inflammatory skin disease and leads the clinical service for eczema, skin allergy and drug hypersensitivity reactions. His clinical unit undertakes clinical trials in atopic eczema and other skin diseases. MAJ has long-standing research interest in all aspects of atopic eczema including: immunological mechanisms, immunotherapy, and the skin microbiome. His research lab comprises post-doctoral scientists, PhD students, clinical fellows and technicians.

Michael Ardern-Jones is President of the British Society for Medical Dermatology and Immediate Past Chair of the British Society for Investigative Dermatology. He also chairs The Skin Investigation Society. He is lead author on the Atopic eczema chapters and co-author for Drug allergy in Rook’s Textbook of Dermatology. He is an expert advisor to NICE and the MHRA on dermatology.

University Hospital of Wales

Dr John Ingram

             

Senior Lecturer and Consultant Dermatologist, Cardiff University and Cardiff & Vale University Health Board, with a particular interest in inflammatory skin disease. Editor-Elect of the British Journal of Dermatology and recipient of a five year Health Fellowship from Health and Care Research Wales (HCRW). Dermatology Specialty Lead for HCRW, coordinating dermatology clinical trials activity across Wales.

Inclusion criteria

  • Paediatric and adult patients with atopic eczema who due to the severity of their disease and/or impact on quality of life are commencing on or switching to another systemic immuno-modulatory agent (e.g. CyA, AZA, MTX or biologic treatments).
  • Written informed consent for study participation obtained from the patient or parents / legal guardian, with assent as appropriate by the patient, depending on the level of understanding.
  • Participants consent to participate in long-term follow up and access to all medical records, including hospital admission records and linkage to data held by NHS bodies or other national providers of healthcare data.
  • Diagnosis of atopic eczema in keeping with the UK/Irish diagnostic criteria.
  • Willingness to comply with all study requirements.
  • Competent use of English language, according to patient’s age (capable of understanding patient questionnaires).

Exclusion Criteria

  • Insufficient understanding of the study by the patient and/or parent/guardian.
  • Patients who are currently participating in a randomised clinical trial.

Safety reporting responsibilities for Principal Investigators

Event When How To Whom
All Adverse Events Anytime Via electronic CRF Study co-ordinating centre

 

Drug-related Serious Adverse Reactions Anytime Electronic submission through:

-Yellow card scheme for UK sites https://yellowcard.mhra.gov.uk/yellowcards/reportmediator/

-HPRA website for Irish sites https://www.hpra.ie/homepage/about-us/report-an-issue (Human Medicine Adverse Reaction)

-Study co-ordinating centre: eCRF

 

MHRA (UK) or HPRA (Ireland).

 

Study co-ordinating centre

Adverse Reactions for Medicines under additional monitoring a Anytime Electronic submission through:

-Yellow card scheme for UK sites https://yellowcard.mhra.gov.uk/yellowcards/reportmediator/

-HPRA website for Irish sites https://www.hpra.ie/homepage/about-us/report-an-issue (Human Medicine Adverse Reaction)

-Study Co-ordinating Centre: eCRF

 

MHRA (UK) and HPRA (Ireland).

 

 

Study Co-ordinating Centre

a. Medicines under additional monitoring are those who display an inverted Black Triangle in the SmPC. The black triangle symbol identifies newly licensed medicines that require additional monitoring by the EMA. Such medicines include new active substances, biosimilar medicines, and medicines that the EMA consider require additional monitoring. The latest list can be found in: www.mhra.gov.uk/blacktriangle or EMA website.

Protocol

A-STAR protocol V1_22Mar18

Patient Information Sheets, Informed Consent forms & Assent Forms

A-STAR Adult PIS-ICF V1.1_4Jul18

ASTAR Parents_guardians PIS-ICF V1.1_4Jul18

A-STAR Youngperson PIS AF V1.1_4Jul18

A-STAR Children PIS AF v 1.0_16Feb18

A-STAR Very Young Children PIS AF v 1.0_23Apr18

 

Withdraw Forms

A-STAR Patient withdraw Form V1_23Apr18

A-STAR Withdraw Form Minor & Carer V1_23Apr18

 

Questionnaires

 ! This material is copyright protected and can only be used by the investigational sites, for the purpose of delivering A*STAR. The documents must not be reproduced, modified or used for any other purpose.

Adults

EQ-5D UK: EQ-5D-5L questionnaire English version A-STAR v1.0 18Jul18

EQ-5D Ireland: EQ-5D-5L questionnaire_Ireland (English) A-STAR V1.0 13Aug18

poem-for-self-completion-A-STAR V1.0 18Jul18

Dermatology Life Quality Index: DLQI A-STAR V1 18Jul18

Asthma Control Test:  A-STAR ACT V1.0 24Aug18

Children

EQ-5D-Y questionnaire A-STAR v1.0 18Jul18

Children’s Dermatology Life Quality Index: CDLQI A-STAR V1 18Jul18 

Children’s Dermatology Life Quality Index (cartoons): CDLQI Cartoon English V1 16Oct18

Infants’ Dermatology Quality of Life: IDQOL A-STAR V1 18Jul18

Parents/Carers

POEM proxy poem-for-proxy-completion- A-STAR V1.0 18Jul18

EQ-5D proxy EQ-5D-Y PROXY questionnaire_UK (English) A-STAR V1.0 29Aug18

Site Staff

EASI A-STAR V2.0 9Oct18

Validated Investigator Global Assessment Scale_vIGA-AD_2017

Paper CRF: A-STAR CRF V1.0 25Sep18

! A new version of the CRF will be available soon.

eCRF: https://ecrf.astar-register.org/login/

CAPTURE: https://capture.gstt.nhs.uk/

MedDRA

https://www.meddra.org/training-materials

Skin examination

ASTAR skin examination protocol

 

Eczema diagnosis manual, including fieldworker test (read the sections on the UK diagnostic criteria, look at the 48 training photographs (Section 1.3 The UK diagnostic criteria for atopic eczema; Section 3.2. The sign of flexural dermatitis) and then take the fieldworker test: ‘test photographs’, Appendix 5):

https://www.nottingham.ac.uk/~mzzfaq/dermatology/eczema/