Nottingham Clinical Trials Unit
The University of Nottingham
University of Nottingham
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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 is 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, can 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. Recruitment began in November 2014. The aim is to recruit 1282 families over 2 years, at 16 sites.

Contact:  Rachel Haines

 Funding:  NIHR Health Technology Assessment

 Status:  Recruiting

 Further Information: Rachel Haines (Trial Manager) 





Trial Name:  Bullous pemphigoid steriods and tetracyclines study (BLISTER)

Chief Investigator:  Hywel Williams, University of Nottingham

Trial Description:  Bullous pemphigoid is an autoimmune skin disorder characterised by large blisters, which can cause considerable pain and distress. It may be acute or chronic, and is most common in people over 70 years of age.

This study is comparing the antibiotic doxycycline (a tetracycline) with prednisolone (a corticosteroid) for treatment of bullous pemphigoid. Both drugs are given as a single daily oral dose. The primary outcomes are blister control at six weeks, and severe or life threatening events at one year. The trial recruited from 57 sites, 50 in the UK and 7 in Germany. Recruitment closed having reached target accrual of 256 patients in September 2013.

Contact:  Beki Haydock

Funding:  NIHR Health Technology Assessment

Status:  In press

Publications:  2012-7

Further Information:  Beki Haydock (Trial Manager)






Trial Name: Randomised controlled trial of silk therapeutic clothing for the long-term management of eczema in children (CLOTHES)

Chief Investigator:  Kim Thomas, The University of Nottingham

Trial Description:  Eczema is a chronic, inflammatory skin condition that impacts on the quality of life of of patients and their families. Some types of clothing can cause irritation to the skin, and current guidelines recommend the use of loose cotton clothing, and the avoidance of wool and other rough fibres next to the skin. In response to this need, new clothing products have become available in recent years, and these are now marketed as having beneficial effects in the treatment of eczema.

The therapeutic silk garments included in this trial are available on prescription through the NHS, but the trial evidence supporting their use is currently limited. The trial objectives are to: 1) assess whether silk therapeutic clothing, when used in addition to standard eczema care, reduces eczema severity in children over a period of six months, 2) estimate the within trial cost-effectiveness of silk therapeutic clothing with standard care, compared to standard care alone, from an NHS and a family perspective. The primary outcome is eczema severity, as assessed by research nurses who are blinded to particpant group allocation.

Recruitment took place from November 2013 to May 2015, 300 children with moderate to severe eczema were recruited from five sites, and follow-up was completed in December 2015.

Contact:  Ellie Harrison

Funding: NIHR Health Technology Assessment

Status:  Analysis and Reporting

Publications:  2015-14

Further Information:  Ellie Harrison (Trial Manager)






Trial Name:  Fibreglass casts in the management of ulcers of the heel in diabetes (HEELS)

Chief Investigator:  William Jeffcoate, Nottingham University Hospitals NHS Trust

Trial Description:  Up to 15% of people with diabetes develop chronic ulceration of their foot, and this is most common among the elderly. Two-thirds of foot ulcers heal within 12 months, but of these 40% will recur within 12 months. Lightweight fibreglasss heel casts are used for heel ulcers in the belief that they improve healing and reduce pain and discomfort. These casts take 15 minutes to mould to the heel, are applied over the primary wound dressing, and held in place with an outer dressing. They can be worn inside shoes, and need to be replaced on average every three weeks.

This trial is comparing ususal care plus fibreglass heel casts with usual care alone for the management of ulcers of the heel in diabetes. The primary outcome is ulcer healing at 24 weeks. Recruitment closed in September 2014 having reached target accrual of 509 participants.

Contact:  Clare Brittain

Funding:  NIHR Health Technology Assessment

Status:  Analysis and Reporting

Publications:  2012-14; 2014-6;

Further Information:  Clare Brittain (Senior Trial Manager)





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 is 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 aims to recruit 440 adults and children over the age of 5 across the UK who have non-segmental vitiligo, and at least one patch of vitiligo which has shown to be active in the past 12 months. Participants will be asked to treat their vitiligo patches with ointment and a light therapy unit at home, for a period of 9 months. Recruitment began in May 2015. 

Contact:  Garry Meakin

 Funding:  NIHR Health Technology Assessment

 Status:  Recruiting

 Further Information:  Garry Meakin (Trial Manager)



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. Estimated sample size of 250 participants. The study opened to recruitment in August 2013. Recruitment is at 35 sites in the UK, Sweden and Denmark.

 Contact: Ellie Harrison

 Funding:  Reapplix

 Status:  Recruiting

 Further Information:  Ellie Harrison (Trial Manager)




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