Condition category
Skin and Connective Tissue Diseases
Date applied
17/12/2014
Date assigned
15/01/2015
Last edited
18/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Patients with kidney disease often suffer from itchy skin. Constant scratching can lead to skin damage and changes to the skin’s appearance. Some patients are so troubled by itching that they can lose sleep, or even become depressed. We are not sure what causes the itching in kidney disease – it probably has many different causes, for example a build-up of toxins or blood salts in the skin. Many treatments are tried but they can often be unsuccessful, and currently there is no known cure for this distressing condition. The aim of this study is to see whether Balneum Plus works on the itch caused by kidney disease. Balneum Plus is already on the market and available to buy over-the-counter. It is used in other skin conditions like eczema and psoriasis, and it is safe to use in these conditions.

Who can participate?
Adult patients receiving haemodialysis for the treatment of End-Stage Renal Disease (ESRD) for at least 3 months

What does the study involve?
Patients are divided into two groups in a random fashion – meaning that each group will be similar in terms of age, type of kidney disease etc. One group will receive Balneum Plus and the other group will receive an inactive cream, called a placebo. Neither the patient nor the trial staff will know which cream is given to which patient. This method is used to make sure the study is scientifically fair.
The patient will be asked to apply the cream to areas of itchy skin, twice daily, for four weeks. Each week, we will ask each patient to score the intensity of their itching. At the beginning and end of the trial, each patient will fill in a questionnaire to assess the impact of the cream on their quality of life. Measurements and questionnaires will be filled in whilst each patient attends for their routine haemodialysis session so that no additional visits to the hospital are required. No additional blood tests, other than the patient’s routine monthly blood tests will be required.

What are the possible benefits and risks of participating?
Once the study is finished, we will inform all participants of the results. If Balneum Plus is shown to be useful in treating the itchy skin caused by kidney disease, we hope to be able to make an impact in treating this condition. There are not thought to be any risks in using the cream, but rigorous safety procedures will be in place

Where is the study run from?
Queen Alexandra Hospital, Portsmouth (UK)

When is the study starting and how long is it expected to run for?
January 2015 to April 2015

Who is funding the study?
Almirall Ltd (UK)

Who is the main contact?
Dr Jaqueline Nevols

Trial website

Contact information

Type

Public

Primary contact

Dr Jacqueline Nevols

ORCID ID

Contact details

Wessex Kidney Centre
Queen Alexandra Hospital
Portsmouth
PO15 7HW
United Kingdom

Additional identifiers

EudraCT number

2014-005594-36

ClinicalTrials.gov number

Protocol/serial number

PHT/2014/107

Study information

Scientific title

A Randomised, Double-Blind, Placebo-CONTrolled, Parallel Group Trial to Evaluate the Effectiveness and Safety of Balneum Plus in the Treatment of UraemIC PruriTus in Haemodialysis Patients

Acronym

The DONT ITCH Trial

Study hypothesis

Balneum Plus cream is superior to emollient control in the treatment of uraemic pruritus in haemodialysis patients.

Ethics approval

South Central - Hampshire B Research Ethics Committee, 13/11/2015 ref: 15/SC/0478

Study design

Single centre randomised double-blind placebo-controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Uraemic pruritus in adult haemodialysis patients.

Intervention

Topical application of Balneum Plus cream or emollient control (as placebo) to affected areas, twice daily, for four weeks.

Intervention type

Drug

Phase

Phase IV

Drug names

Balneum Plus cream. 3.0% urea and 5.0% Lauromacrogols as the active ingredients.

Primary outcome measures

Reduction in itch intensity as measured by visual analogue scale, at weekly intervals for 4 weeks.

Secondary outcome measures

Quality of life as measured by a validated questionnaire for itch in renal disease. The questionnaire will be filled in at baseline and then again after 4 weeks. Safety data in terms of adverse events will be collected weekly and usage requirements data collected at the end of the trial.

Overall trial start date

01/01/2015

Overall trial end date

01/04/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or Female, aged 18 or above
2. Receiving haemodialysis for the treatment of End-Stage Renal Disease (ESRD) for at least 3 months
3. Participant is willing and able to give informed consent for participation in the study
4. Self reported symptoms of uraemic pruritus. Itch will be defined as at least 3 episodes of itch during the last 2 weeks, several times a day for more than 5 minutes and being bothersome
5. VAS score of at least 2cm

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

58 patients.

Participant exclusion criteria

1. Any other skin condition e.g. psoriasis, atopic dermatitis
2. Taking any oral medication for UP other than antihistamines e.g. opiates, gabapentin
3. Acute erythroderma, acute inflammatory, oozing or infected skin lesions
4. Use of topical skin medication containing any active ingredients (anything other than simple emollient)
5. Liver disease
6. Malignancy
7. Cognitive impairment that may impact on their ability to fill in the quality of life questionnaire e.g. a previous diagnosis of dementia
8. Lack of a good understanding of English
9. Unwilling to apply the topical treatment as prescribed, including a previous history of poor-compliance with any treatment
10. Significant ongoing illness requiring inpatient treatment
11. Allergy to Balneum Plus or any of its ingredients
12. Pregnancy or Breastfeeding

Recruitment start date

01/02/2015

Recruitment end date

01/03/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Portsmouth Hospitals NHS Trust
Queen Alexandra Hospital
Portsmouth
PO6 3LY
United Kingdom

Sponsor information

Organisation

Portsmouth Hospitals NHS Trust

Sponsor details

Queen Alexandra Hospital
Southwick Hill Road
Portsmouth
PO6 3LY
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Almirall Ltd.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned to present the results at a national renal meeting and publish in a renal journal in due course.

Intention to publish date

31/12/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

18/04/2016: Ethics approval information added.