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

Portsmouth Hospitals NHS Trust0 sites58 target enrollmentJanuary 15, 2015

Overview

2023 Results article in https://doi.org/10.1093/ckj/sfad066 (added 13/02/2024)

Registry

who.int

Start Date

January 15, 2015

End Date

April 1, 2015

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•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

•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