Balneum Plus cream for the treatment of itchy skin in renal patients

Phase 4

Completed

• Conditions: raemic pruritus in adult haemodialysis patients.; Skin and Connective Tissue Diseases; Uraemic pruritus

• Registration Number: ISRCTN13971661
• Lead Sponsor: Portsmouth Hospitals NHS Trust

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-15
• Study Completion: 2015-04-01
• Last Update Posted: 27 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 58

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in itch intensity as measured by visual analogue scale, at weekly intervals for 4 weeks.

Secondary Outcome Measures

Name	Time	Method
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.