The DON'T ITCH Trial. Version 1.0
Research type
Research Study
Full title
A Randomised, Double-Blind, Controlled, Parallel Group Trial to Evaluate the Effectiveness and Safety of Balneum Plus in the Treatment of Uraemic Pruritus in Haemodialysis Patients.
IRAS ID
166323
Contact name
Robert Lewis
Contact email
Sponsor organisation
Portsmouth Hospitals NHS Trust
Eudract number
2014-005594-36
ISRCTN Number
ISRCTN13971661
Duration of Study in the UK
0 years, 3 months, 1 days
Research summary
Patients with kidney disease often suffer from itchy skin. Some patients are so troubled by itching that they can lose sleep, or become depressed. We don’t know for sure what causes the itching in kidney disease and there is no known cure for this distressing condition.
We are doing a clinical trial of a cream called Balneum Plus to see if it is effective in treating 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.
The trial participants will be divided into two groups in a random fashion. One group will receive Balneum Plus and the other group will receive an inactive cream, called a placebo.
Each patient will be fully informed about the trial and asked to sign a consent form. There are not thought to be any risks in using the cream, but rigorous safety procedures will be in place. The patient will apply the cream to areas of itchy skin, twice daily, for four weeks. Each week, the patient will score the intensity of their itching. At the beginning and end of the trial, each patient will fill in a questionnaire to assess 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.
All patient data will be kept strictly confidential.Once the trial 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.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
15/SC/0478
Date of REC Opinion
13 Nov 2015
REC opinion
Further Information Favourable Opinion