Uraemic pruritus in adult haemodialysis patients. Skin and Connective Tissue Diseases Uraemic pruritus
Conditions
Interventions
Topical application of Balneum Plus cream or emollient control (as placebo) to affected areas, twice daily, for four weeks.
Sponsors
Portsmouth Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in itch intensity as measured by visual analogue scale, at weekly intervals for 4 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
England, United Kingdom
Contacts
Public ContactJacqueline Nevols
Outcome results
None listed