Nottingham Clinical Trials Unit
The University of Nottingham
University of Nottingham
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SKIN AND WOUND

 

Beep

 


Trial Name:  Barrier Enhancement for Eczema Prevention (BEEP)

Chief Investigator:  Hywel Williams, The University of Nottingham

Trial Description:  Eczema is a common skin problem affecting 16% to 30% of children in the UK, and around 20% worldwide. The onset of eczema usually occurs in infancy, and generally dry skin is one of the first abnormalities in babies who eventually develop the condition. It is thought that skin barrier dysfunction (dry skin and increased trans-epidermal water loss) could be a primary event in the development of eczema and atopy. Emollient therapy has been shown to improve skin barrier function by providing lipids to the stratum corneum (the outermost layer of skin), in turn improving skin hydration by trapping in water. Early and regular use of emollient could lead to a potential improvement in skin barrier function.

The primary objective of this trial was to determine whether advising parents to apply emollient to their child's skin daily for the first year of life, in addition to best practice infant skin care advice, could prevent or delay the onset of eczema in high-risk children, when compared with a control group who are given the best practice infant skin care advice only. Primary outcome was eczema at 2 years of age.  Primary and secondary outcomes were analysed in 2019.  Long term follow up until 5 years of age continues through December 2021.

Contact:  Rachel Haines

 Funding:  NIHR Health Technology Assessment

 Status:  Long Term Follow up

Publications: 2017-14

 Further Information: Rachel Haines (Trial Manager) beep@nottingham.ac.uk 

 

HiLight

 

Data analysis from the Hi-Light trial is complete and the full results are currently going through the publications process.  In the meantime, we have shared a summary of results with study participants via a newsletter.  Some participants who withdrew from the study may also have received a newsletter in error.  Steps have been taken to ensure that this does not happen again, but if you have any concerns regarding your data protection please contact us at hilight@nottingham.ac.uk

Trial Name:  Home Interventions and Light Therapy for the Treatment of Vitiligo (HI-Light)

Chief Investigator:  Jonathan Batchelor,  Derby Hospitals NHS Foundation Trust and the University of Nottingham

Trial Description:  Vitiligo causes loss of pigment on the skin and white patches appear in the affected areas. This condition affects areas. This condition affects around 1% of the population worldwide, and patients with vitiligo can experience problems such as shame, depression, and low self-esteem due to the appearance of their skin. There is no cure for vitiligo, as the cause of the condition is not understood. Treatment options for small areas of vitiligo are limited; small patches are sometimes treated with topical corticosteriod ointments. Narrowband Ultraviolet B light therapy (NB-UVB) may also be offered as a treatment, but it involves frequent visits to hospital and is mainly used for widespread vitiligo. Hand-held NB-UVB light units are available to use in the home on small patches of vitiligo, though these are not available on the NHS. Previous vitiligo research suggests that combination therapies (topical steroid and light therapy) may prove more effective in the treatment of the condition than either therapy alone, though the efficacy of these combined treatments has yet to be established.

The objective of this trial was to provide information on the comparative effectiveness and safety of topical corticosteriods (mometasone furoate 0.1% ointment) versus (i) home-based NB-UVB light, and (ii) the combination of topical corticosteroids and home-based NB-UVB light for early and limited vitiligo in adults and children.  The trial recruited 517 adults and children over the age of 5 between May 2015 and September 2017 across the UK with non-segmental vitiligo, with at least one patch of vitiligo which has shown to be active in the last 12 months.  Participants treated their vitiligo patches with ointment and a light therapy unit at home, for a period of 9 months. Participants were then followed up by post for a period of 12 months, primarily to assess the maintenance of any treatment response.

The follow-up stage of the trial ended on 31 December 2018 and the trial is now in closeout.  Results of the trial are due to be published early 2020.

Contact:  Garry Meakin

 Funding:  NIHR Health Technology Assessment

 Status:  Follow-up

Publications: 2016-2; 2018-13

 Further Information:  Garry Meakin (Trial Manager)  hilight@nottingham.ac.uk

 

 

LeucoPatch 1

 

 

 Trial Name:  LeucoPatch® in the management of hard to heal diabetic foot ulcers

 Chief Investigators:  UK - Frances Game, Derby Teaching Hospitals NHS Foundation Trust; Sweden - Magnus Londahl, Skane University Hospital; Denmark - Lise Tarnow, Nordsjaellands Hospital

 Trial Description: Diabetic foot ulcer is a common and severe complication of diabetes melitus and despite improved outcomes remains the dominating reason for non-traumatic leg amputations in most western countries. LeucoPatch® is produced from patient's own venous blood by centrifugation, the final product comprising of a thin circular plug composed predominantly of fibrin with living platelets and leucocytes. The number of plugs used is determined by the size of the individual wound.

This trial sets out to demonstrate whether the application of LeucoPatch® used in conjunction with usual care is superior to usual care alone. The primary outcome will be percentage of ulcers healed within 20 weeks.  Recruitment to the trial took place from August 2013 to May 2017 at sites in the UK, Sweden and Denmark.  A total of 595 patients were consented, and 269 of these went on to be randomised.  Participant follow-up is completed and trial has been published.

 Contact: Aisha Shafayat

 Funding:  Reapplix

 Status:  Published

Publications: 2018-23

 Further Information:  Ellie Harrison (Trial Manager) leucopatch@nottingham.ac.uk

 

 

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