Balneum Plus cream for the Treatment of Itching in Kidney Disease
- Conditions
- raemic PruritusMedDRA version: 18.1 Level: PT Classification code 10060875 Term: Uraemic pruritus System Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2014-005594-36-GB
- Lead Sponsor
- Portsmouth Hospitals NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 58
The participants must meet ALL of the following criteria to be considered eligible for the study:
•Male or Female, aged 18 years or above.
•Receiving haemodialysis for the treatment of ESRD for at least 3 months.
•Participant is willing and able to give informed consent for participation in the study.
•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 bothersome20.
•VAS score of at least 2cm
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 29
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 29
The participant may not enter the study if ANY of the following apply:
•Any other skin condition e.g. psoriasis, atopic dermatitis
•Taking any oral medication for UP other than antihistamines e.g. opiates, gabapentin
•Acute erythroderma, acute inflammatory, oozing or infected skin lesions
•Use of topical skin medication containing any active ingredients (anything other than simple emollient)
••Any chronic liver disease in the participant’s past medical history that may cause itch, as deemed by the assessing clinician.
•Solid organ malignancy
•Cognitive impairment that may impact on their ability to fill in the quality of life questionnaire e.g. a previous diagnosis of dementia.
•Lack of a good understanding of English.
•Unwilling to apply the topical treatment as prescribed, including a previous history of poor-compliance with any treatment.
•Significant ongoing illness requiring inpatient treatment.
•Allergy to Balneum Plus or any of its ingredients.
Breastfeeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): The primary outcome measure will be reduction in itch intensity as measured by visual analogue scale. ;Timepoint(s) of evaluation of this end point: Patients will score their itch intensity on a Visual Analogue Scale once a week for four weeks during the trial.;Main Objective: To compare itch intensity as measured by a Visual Analogue Scale after 4 weeks treatment with Balneum Plus cream vs emollient control in patients with uraemic pruritus.;<br> Secondary Objective: To compare effect on quality of life as measured by a validated questionnaire (Itching in Kidney Disease) after 4 weeks treatment with Balneum Plus cream vs emollient control in patients with uraemic pruritus.<br><br> To assess the safety of Balneum Plus cream used in this participant population.<br><br> To describe the usage requirements of Balneum Plus and emollient control.<br>
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): The secondary outcomes will evaluate the effect of Balneum Plus on quality of life. Safety data in terms of adverse events will be recorded.<br> Usage requirements of the cream will be recorded.<br> ;<br> Timepoint(s) of evaluation of this end point: Patients will fill in a quality of life questionnaire at the beginning of the trial and again after four weeks.<br> Adverse events will be recorded weekly for four weeks, and again one week after the patient has finished applying the cream.<br> The cream containers will be weighed before and at the end of the study to assess the usage of Balneum Plus and emollient control.<br>