Previous clinical trials

An alphabetical list of all clinical trials previously undertaken by Sheffield Dermatology Research.

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B

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

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’.

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)

C

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

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

Comparison of protein quantification methods using infrared densitometry against a BCA assay on stratum corneum tape-strippings

Control functional mechanistic study on skin barrier function and protease activity (no treatment)

  • Funded by: Kuwait Ministry of Health

E

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

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)

ExTRA

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

  • Funded by: LEO Pharmaceuticals
  • Site Investigators: Michael J. Cork (National Chief Investigator)

Effect of Aqueous cream BP on the skin barrier in volunteers with a previous history of atopic dermatitis

  • Funded by: Kuwait Ministry of Health

Effect of Intensive Washing with Soap on the Biophysical properties of the Skin

Effect of water hardness on skin surface pH and SLS deposition on the skin

Emollient study phase C: Mechanistic evaluation of the effects of topical treatment with two lead emollient formulations

  • Funded by: Merck, Sharp, Dohme (MSD)

Effect of water softeners on SLS skin deposition and hard-water modified SLS skin irritation

  • Funded by: Harvey Water Softeners Ltd.

Effect of honey on the skin barrier in volunteers with a previous history of atopic dermatitis

  • Funded by: Kuwait Ministry of Health

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

The Effect of Balneum Cream on the Biophysical and Biological Properties of Aged Skin

Funded by: Almirall

F

A functional mechanistic study of the effect of tacrolimus and topical corticosteroids on skin barrier function and protease activity

  • Funded by: Astellas Pharma

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)

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

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)

I

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

Identification of Biomarkers Associated with Atopic Eczema, Irritant Contact Dermatitis and Sensitive Skin

  • Funded by: Molecular SkinCare

J

JADE

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

  • Funded by: Pfizer
  • Site Investigators: Michael J. Cork (National Chief Investigator)

JADE Extn

A phase 3 randomized, double-blind, multi-centre, 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

  • Funded by: Pfizer
  • Site Investigators: Michael J. Cork (National Chief Investigator) 

L

Liberty-1

A Study to Determine the Safety and Tolerability of Dupilumab (REGN668) in Patients Aged ≥6 to <18 Years With Atopic Dermatitis (Eczema)

  • 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

Liberty-2

A phase 2/3 study investigating the pharmacokinetics, safety, and efficacy of Dupilumab in patients aged 6 months to 6 years, with Severe Atopic Dermatitis (Liberty-2) (PART A)

  • Funded by: Regeneron Pharmaceuticals
  • Site Investigators: Michael J. Cork (National Chief Investigator)

M

Mechanistic evaluation of bath emollients for the treatment of atopic dermatitis

Mechanistic evaluation of the short-term effects of new emollient formulations (Phase B)

  • Funded by: Merck, Sharp, Dohme (MSD)

Mechanism of the effect of topical corticosteroids and pimecrolimus on epidermal barrier structure, gene expression and biological function

  • Funded by: Novartis

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

N

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

P

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)

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)

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)

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)

Pilot/validation study of skin barrier recovery for Anti Protease Cream and variant

  • Funded by: Molecular SkinCare

Preliminary assessment of the skin buffering capacity of emollient creams

  • Funded by: Hyphens Pharma

Q

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.

R

RESTORE (Phase 1)

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

RESTORE (Phase 2)

An investigation of the skin barrier restoring effects of a ceramide cream

  • 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

Resource use and treatment patterns in atopic dermatitis patients

  • Funded by: Sanofi
  • Site Investigators: Michael J. Cork (National Chief Investigator)

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)

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

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

Relationship between stratum corneum structure, protease activity, and IL-α levels in atopic dermatitis

S

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

SOLO-1

Phase 3 confirmatory study investigating the efficacy and safety of Dupilumab monotherapy administered to adult patients with moderate-to-severe atopic dermatitis 

  • Funded by: Regeneron Pharmaceuticals
  • Site Investigators: Michael J. Cork (National Chief Investigator)

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

SOLO-OLE

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)

T

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/

V

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

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