Balneum Plus cream for the treatment of itchy skin in renal patients
| ISRCTN | ISRCTN13971661 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13971661 |
| EudraCT/CTIS number | 2014-005594-36 |
| Secondary identifying numbers | PHT/2014/107 |
- Submission date
- 17/12/2014
- Registration date
- 15/01/2015
- Last edited
- 13/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
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
Contact information
Public
Wessex Kidney Centre, Queen Alexandra Hospital
Portsmouth
PO15 7HW
United Kingdom
Study information
| Study design | Single centre randomised double-blind placebo-controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| 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 |
| Study 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(s) | South Central - Hampshire B Research Ethics Committee, 13/11/2015 ref: 15/SC/0478 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Balneum Plus cream. 3.0% urea and 5.0% Lauromacrogols as the active ingredients. |
| Primary outcome measure | 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 study start date | 01/01/2015 |
| Overall study end date | 01/04/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 58 patients. |
| Total final enrolment | 58 |
| 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 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
- England
- United Kingdom
Study participating centre
Portsmouth
PO6 3LY
United Kingdom
Sponsor information
Hospital/treatment centre
Queen Alexandra Hospital, Southwick Hill Road
Portsmouth
PO6 3LY
England
United Kingdom
"ROR" |
https://ror.org/009fk3b63 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/11/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned to present the results at a national renal meeting and publish in a renal journal in due course. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 17/06/2020 | No | No | ||
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 29/03/2023 | 13/02/2024 | Yes | No |
Editorial Notes
13/02/2024: Publication reference added.
17/06/2020: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.
31/05/2018: The intention to publish date has been changed from 31/12/2016 to 30/11/2018.
25/05/2018: No publications found, verifying study status with principal investigator
18/04/2016: Ethics approval information added.
