Clinical Trials
If you’re interested in taking part in our studies please contact us at:
Email: skinresearch@sheffield.ac.uk
Tel: 0114 215 9539
Or you can register your interest here:
Current clinical trials
PELISTAD - Extension
Dupilumab-PEdiatric Skin Barrier Function and LIpidomics STudy in Patients With Atopic Dermatitis - Extension
Open-label exploratory study to evaluate the effect of dupilumab on skin barrier function in pediatric patients with moderate-to-severe atopic dermatitis.
Funded by: Sanofi
Contact details:
Status: OPEN
Please click on poster for more details
This trial aims to answer the question that every parent asks about Dupilumab treatment for their child’s atopic dermatitis (atopic eczema).
“How long will we have to use Dupilumab before it is safe to stop it and the atopic dermatitis (AD) will not return?”
In order to have the best chance that AD will not return it is important to continue the Dupilumab until it has gone from both the surface of the skin and underneath the skin. We have developed a virtual skin biopsy using Optical Cohesive Tomography (OCT). This allows us to see through the skin using infra-red light to determine if the AD under the skin has resolved. OCT is like ultrasound but more sophisticated and you do not feel anything when the probe is put on your skin.
OPTIMISE
OPTical coherence tomography to Investigate the Microscopic changes in Irritated Skin in different skin typEs
Contact details: skinresearch@sheffield.ac.uk
Status: OPEN
Please click on poster for more details
COSMOS
Characterisation Of Skin MicrOstructure under normal and atrophied States
Contact details:
Status: OPEN
SMART 2
Skin bioMARkers for atopic eczema Therapy evaluation study 2
Validation of a novel composite of skin biomarkers as a primary outcome measure for evaluating the safety of treatments for atopic dermatitis.
Funded by: Pfizer
Contact details: skinresearch@sheffield.ac.uk
Status: CLOSED
Please click on poster for more details
BRaCE
An investigation of the skin Barrier Reinforcing effects of a cream containing Ceramides in a multi vesicular emulsion in people with dry, Eczema-prone, skin
Contact details: skinresearch@sheffield.ac.uk
Status: CLOSED
BEPAIR
Contact details: oskatibi1@sheffield.ac.uk
Status: Closed
SUDS
Analysis of SLS Uptake in Atopic Dermatitis patients using Fourier Transform Infrared Spectroscopy
Funded by: EPSRC
Contact details: 0114 215 9539
Status: Closed
Please click on poster for more details
SMART 1
Skin bioMARkers for atopic eczema Therapy evaluation
Validation of a novel composite of skin biomarkers as a primary outcome measure for evaluating the safety of treatments for atopic dermatitis.
Funded by: Pfizer
Contact details: skinresearch@sheffield.ac.uk
Site investigators: Michael J. Cork, Simon G. Danby, Stephen J. Matcher, Robert A. Byers, Rosie Taylor
Status: Closed
Reference: NCT04194814 and 20/EM/0006
Please click on poster for more details
SPOT
Skin Pathology assessment with Optical Technologies
A cross-sectional clinical study in atopic dermatitis patients and healthy subjects.
Funded by: LEO Pharmaceuticals
Contact details: spotstudy@sheffield.ac.uk
Site investigators: Michael J. Cork, Simon G. Danby, Robert Byers
Status: Closed
Reference: NCT04295824 and 19/YH/0367
Please click on poster for more details
PELISTAD
Dupilumab-PEdiatric Skin Barrier Function and LIpidomics STudy in Patients With Atopic Dermatitis
Open-label exploratory study to evaluate the effect of dupilumab on skin barrier function in pediatric patients with moderate-to-severe atopic dermatitis.
Funded by: Sanofi
BOND
Barrier Optimising skincare for Newborn Development
A randomised controlled trial of a specially designed wash product and lotion for the maintenance of healthy skin and mind in babies (Phase 1 & 2)
Funded by: Johnson & Johnson
Contact Details: BOND@sheffield.ac.uk
Site Investigators: Michael J. Cork, Simon G. Danby, Shatha Shibib, Tina Lavender
Status: Closed
Reference: NCT03142984 and 17/YH/0083
STAR
Skin Testing for Atopic eczema Risk
A longitudinal investigation of skin barrier development from birth and the validation of early predictors of AD risk.
Funded by: The LEO Foundation
Contact Details: starstudy@sheffield.ac.uk
Site Investigators: Simon G. Danby, John Chittock, Alison Cook, Tina Lavender, Michael J. Cork
Status: Completed
Reference: 16/NW/0848
BARRIER
Effect of a barrier repair cream on the skin
Funded by: Hyphens
Contact details: skinresearch@sheffield.ac.uk
Site investigators: Simon G. Danby, Michael J. Cork, Kirsty Kennedy, John Chittock, Paul Andrew, Abigail Pinnock
Status: Recruitment paused
Reference: 019255
Open-label Study of Dupilumab (REGN668) in Paediatric Patients With Atopic Dermatitis
An open-label extension study to assess the long-term safety and efficacy of dupilumab in patients’ ≥6 to <18 years of age with Atopic dermatitis R668-AD-1434. (Liberty-OLE)
Funded by: Regeneron Pharmaceuticals
Site Investigators: Michael J. Cork (National Chief Investigator)
Status: Closed to recruitment
Reference: NCT01949311
Examples of previous clinical trials
A phase 2/3 study investigating the pharmacokinetics, safety, and efficacy of Dupilumab in patients aged >6months to <6years, with Severe Atopic Dermatitis (PART B)
Funded by: Regeneron Pharmaceuticals, Sanofi ‘R1539 Part B’
Site Investigators: Michael J. Cork (National Chief Investigator)
Long-term extension trial in subjects with atopic dermatitis who participated in previous tralokinumab trials – ExTEND
Funded by: LEO Pharmaceuticals
Site Investigators: Michael J. Cork (National Chief Investigator)
A phase 3 randomized, double-blind, multi-center, long-term extension study investigating the efficacy and safety of pf-04965842, with or without topical medications, administered to subjects aged 12 years and older with moderate to severe atopic dermatitis (JADE Extn)
Funded by: Pfizer
Site Investigators: Michael J. Cork (National Chief Investigator)
RESTORE
An investigation of the skin barrier restoring effects of a ceramide cream (Phase 2)
Funded by: L’Oréal CeraVe
Contact details: skinresearch@sheffield.ac.uk
Site investigators: Simon G. Danby, Michael J. Cork, Kirsty Kennedy, John Chittock, Paul Andrew, Linda Kay
Status: Completed
Reference: 018584
NOVA
A NOVel moisturiser for Atopic dermatitis: effect on the skin barrier
A phase 2 randomised controlled trial of a NOVel moisturiser for Atopic dermatitis: effect on the skin barrier in adults with a predisposition to a skin barrier defect.
Funded by: ACO Nordic AG
Contact details: skinresearch@sheffield.ac.uk
Site investigators: Michael J. Cork, Simon G. Danby
Status: Completed
Reference: NCT03901144 and 18/WM/0311
TREAT
The TREatment of Severe Atopic Eczema Trial
A Randomised Controlled Trial Assessing the Effectiveness, Safety and Cost-effectiveness of Methotrexate versus Ciclosporin in the Treatment of Severe Atopic Eczema in Children.
Funded by: NIHR (CI: Carsten Flohr)
Contact details: Heather Chisem/Stuart Gormley, Tel: 0114 305 3136
Site Investigators: Michael J. Cork, Ruth Murphy
Status: Recruitment closed
Reference: ISRCTN15837754
Website: http://www.treat-trial.org.uk/
BEEP
Barrier Enhancement for Eczema Prevention
A randomised controlled trial to determine whether a skin barrier enhancement package can prevent eczema in high-risk children ‘BEEP’.
Funded by: HTA. Hywel Williams CI Nottingham
Contact details: Heather Chisem/Stuart Gormley, Tel: 0114 305 3136
Site Investigators: Michael J. Cork
Status: Completed
Reference: ISRCTN21528841
Website: http://www.nottingham.ac.uk/research/groups/cebd/projects/1eczema/beep-maintrial.aspx
A Study to Determine the Safety and Tolerability of Dupilumab (REGN668) in Patients Aged ≥6 to <18 Years With Atopic Dermatitis (Eczema)
A Phase 2a Study Investigating the Safety, Pharmacokinetics, Immunogenicity, and Exploratory Efficacy of Dupilumab in Patients Aged ≥6 to <18 Years with Atopic Dermatitis. (Liberty-1).
Funded by: Regeneron Pharmaceuticals
Contact details: Heather Chisem/Stuart Gormley, Tel: 0114 305 3136
Site Investigators: Michael J. Cork (International Chief Investigator)
Status: Completed
Reference: NCT02407756
Study to Assess the Long-term Safety of Dupilumab Administered in Participants ≥6 Months to <6 Years of Age With Atopic Dermatitis (AD)
Funded by: Regeneron Pharmaceuticals
Contact details: Heather Chisem/Stuart Gormley, Tel: 0114 305 3136
Site Investigators: Michael J. Cork (National Chief Investigator)
Status: Recruitment closed - in follow-up
Reference: NCT02407756
CAFÉ
A Phase 3 Study to Assess the Efficacy and Safety of Dupilumab in Patients With Severe Atopic Dermatitis (AD) That Are Not Controlled With Oral Cyclosporine A (CSA) or for Those Who Cannot Take Oral CSA Because it is Not Medically Advisable
Funded by: Regeneron Pharmaceuticals
Site Investigators: Michael J. Cork (National Chief Investigator)
Status: Completed
Reference: NCT02755649
RESTORE
An investigation of the skin barrier restoring effects of a ceramide cream (Phase 1)
Funded by: L’Oréal CeraVe
Contact details: skinresearch@sheffield.ac.uk
Site investigators: Simon G. Danby, Michael J. Cork, Kirsty Kennedy, John Chittock, Paul Andrew, Linda Kay
Status: Completed
Reference: 018584
SOLO 2
Study of Dupilumab (REGN668) Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
A phase 3, randomized, double-blind, placebo-controlled study investigating the efficacy and safety of multiple dupilumab dose regimens administered as monotherapy for maintaining treatment response in patients with atopic dermatitis.
Funded by: Regeneron Pharmaceuticals
Site Investigators: Michael J. Cork (National Chief Investigator)
Status: Completed
Reference: NCT02277769
Resource use and treatment patterns in atopic dermatitis patients
Funded by: Sanofi
Site Investigators: Michael J. Cork (National Chief Investigator)
A Phase II, randomized, double-blind, placebo-controlled repeated-dose study to evaluate the efficacy, safety, tolerability, and PK/PD of intravenously administered MOR106 in adult subjects with moderate to severe atopic dermatitis
Funded by: Galapagos
Site Investigators: Michael J. Cork (National Chief Investigator)
A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Dupilumab Administered Concomitantly with Topical Corticosteroids in Patients, ≥6 Years to <12 years of Age, with Severe Atopic Dermatitis
Funded by: Regeneron Pharmaceuticals
Site Investigators: Michael J. Cork (National Chief Investigator)
A randomised, double-blind, placebo-controlled, phase 3 trial to evaluate the efficacy and safety of tralokinumab monotherapy in subjects with moderate-to-severe atopic dermatitis who are candidates for systemic therapy (ExTRA)
Funded by: LEO Pharmaceuticals
Site Investigators: Michael J. Cork (National Chief Investigator)
European Prospective Observational Study in Patients Eligible for Systemic Immunosuppressive Therapy for Atopic Dermatitis (EUROSTAD)
Funded by: Sanofi
Site Investigators: Michael J. Cork (National Chief Investigator)
A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy and Safety of PF-04965842 Monotherapy in Subjects Aged 12 Years and Older, With Moderate-to-Severe Atopic Dermatitis (JADE)
Funded by: Pfizer
Site Investigators: Michael J. Cork (National Chief Investigator)
A Phase IIa, Randomised, Double Blind, Placebo Controlled, Parallel Group, Multicentre Study of an Anti-OX40L Monoclonal Antibody (KY1005) in Moderate to Severe Atopic Dermatitis
Funded by: KYMAB
Site Investigators: Michael J. Cork (National Chief Investigator)
A phase 2/3 study investigating the pharmacokinetics, safety, and efficacy of Dupilumab in patients aged >6months to <6years, with Severe Atopic Dermatitis (Liberty-2) (PART A)
Funded by: Regeneron Pharmaceuticals
Site Investigators: Michael J. Cork (National Chief Investigator)
A phase 2b, randomized, double-blind, placebo- controlled, parallel-group, dose-ranging study investigating the efficacy, safety, and pharmacokinetic profiles of Regn3500 administered to adult patients with moderate-to-severe atopic dermatitis
Funded by: Regeneron Pharmaceuticals
Site Investigators: Michael J. Cork (National Chief Investigator)
An open-label study of dupilumab in adult patients with Atopic dermatitis who participated in previous Dupilumab clinical trials (SOLO-OLE)
Funded by: Regeneron Pharmaceuticals
Site Investigators: Michael J. Cork (National Chief Investigator)
A phase 3 confirmatory study investigating the efficacy and safety of dupilumab monotherapy administered to adult patients with moderate-to severe atopic dermatitis (SOLO-1)
Funded by: Regeneron Pharmaceuticals
Site Investigators: Michael J. Cork (National Chief Investigator)
An RCT of OC000459 anti-CRTH2 antagonist in Atopic Dermatitis (2013-2015)
Funded by: Atopix / Catalyst-MRC
Site Investigators: Michael J. Cork acting as: co-author for MRC grant application, Chief Investigator for UK and member of Trial Steering Committee
A pilot, assessor-blinded, randomised controlled trial, to assess the impact of olive oil and sunflower oil on a term baby's skin barrier function ‘BOOST’ (2012-2014)
Funded by: NIHR - Doctoral Research Fellowship
Site Investigators: Alison Cooke, Tina Lavender, Simon Danby, Michael J. Cork (co-investigator & co-supervisor)
Baby Skin Care Research Programme: Assessor-blinded randomised controlled trial comparing impregnated cleansing wipes (2010-2013)
Funded by: Johnson & Johnson
Site Investigators: SDR collaboration with Tina Lavender’s group, University of Manchester
Effect on skin hydration of using baby wipes to clean the napkin area of newborn babies: assessor-blinded randomised controlled equivalence trial (2010-2012)
Funded by: Johnson & Johnson
Site Investigators: SDR collaboration with Tina Lavender’s group, University of Manchester
Randomized, Controlled Trial Evaluating a Baby Wash Product on Skin Barrier Function in Healthy, Term Neonates (2010-2012)
Funded by: Johnson & Johnson
Site Investigators: SDR collaboration with Tina Lavender’s group, University of Manchester
Infant skin-cleansing product versus water: A pilot randomized, assessor-blinded controlled trial (2009-2011)
Funded by: Johnson & Johnson
Site Investigators: SDR collaboration with Tina Lavender’s group, University of Manchester
A Multicentre, 5 week, randomized, double blinded, placebo controlled, parallel group study exploring the effects of Elidel Cream 1% vs. placebo control on the molecular and cellular profile of adult male patients with atopic dermatitis
Funded by: Novartis
Validation of skin barrier recovery after tape stripping plus Evaluation of different topical treatment combinations on the recovery of skin barrier following tape stripping and palmar washing
Funded by: Molecular SkinCare
Pilot/validation study of skin barrier recovery for Anti Protease Cream and variant
Funded by: Molecular SkinCare
Identification of Biomarkers Associated with Atopic Eczema, Irritant Contact Dermatitis and Sensitive Skin
Funded by: Molecular SkinCare
Mechanism of the effect of topical corticosteroids and pimecrolimus on epidermal barrier structure, gene expression and biological function
Funded by: Novartis
The effect of Aqueous cream BP on the skin barrier in volunteers with a previous history of atopic dermatitis
Funded by: Kuwait Ministry of Health
A functional mechanistic study of the effect of tacrolimus and topical corticosteroids on skin barrier function and protease activity
Funded by: Astellas Pharma
The effect of natural oils on the skin barrier: Implications for neonatal skin care and the development of atopic dermatitis
Funded by: Kuwait Ministry of Health
A Functional Mechanistic Study of The Effect of Oilatum Junior Bath Oil, Aqueous Cream and Detergent Bubble Bath on Skin Barrier Function
Funded by: Stiefel (GSK)
Control functional mechanistic study on skin barrier function and protease activity (no treatment)
Funded by: Kuwait Ministry of Health
The effect of honey on the skin barrier in volunteers with a previous history of atopic dermatitis
Funded by: Kuwait Ministry of Health
A functional mechanistic study of the effect of emollients on the structure and function of the skin barrier
Funded by: Nottingham University Hospitals Charity & KMoH
A functional mechanistic study to determine the optimum formulation of an emollient base (Part 1 - Irritation Testing)
Funded by: Bayer Dermatology
The Effect of Balneum Cream on the Biophysical and Biological Properties of Aged Skin
Funded by: Almirall
A functional mechanistic study to determine the effect of Diprobase cream, compared with No-Treatment, on the skin barrier (Phase A)
Funded by: Merck, Sharp, Dohme (MSD)
Mechanistic evaluation of the short-term effects of new emollient formulations (Phase B)
Funded by: Merck, Sharp, Dohme (MSD)
Emollient study phase C: Mechanistic evaluation of the effects of topical treatment with two lead emollient formulations
Funded by: Merck, Sharp, Dohme (MSD)
The effect of water softeners on SLS skin deposition and hard-water modified SLS skin irritation
Funded by: Harvey Water Softeners Ltd.
Quantification of surfactant deposits on fabrics following washing in hard water, soft water and artificially softened water using FTIR spectroscopy
Funded by: Harvey Water Softeners Ltd.
A preliminary assessment of the skin buffering capacity of emollient creams
Funded by: Hyphens Pharma
Comparison of protein quantification methods using infrared densitometry against a BCA assay on stratum corneum tape-strippings
The Effect of Intensive Washing with Soap on the Biophysical properties of the Skin
Mechanistic evaluation of bath emollients for the treatment of atopic dermatitis
Relationship between stratum corneum structure, protease activity, and IL-α levels in atopic dermatitis
The effect of water hardness on skin surface pH and SLS deposition on the skin
Characterisation of the skin barrier defect in atopic dermatitis using novel in vivo ATR-FTIR molecular spectroscopy
Cumulative irritation test to investigate the effect of SLS deposition and hard water on the skin
Cyclosporin A in severe childhood atopic eczema (1993-94)
Funded by: Novartis
Site Investigator: Michael J. Cork