Effect of phototherapy on pruritus in primary biliary cholangitis
Research type
Research Study
Full title
The effect of UVB phototherapy on pruritus in primary biliary cholangitis
IRAS ID
204533
Contact name
Nick Reynolds
Contact email
Sponsor organisation
The Newcastle Upon Tyne Hospitals NHS Foundation Trus
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
This pilot study aims to evaluate the potential mechanisms of action of phototherapy on itch in patients with primary biliary cholangitis (PBC). Secondary to this, it will also examine the effects of phototherapy on itch biomarkers and skin microbiome in primary biliary cholangitis(PBC) and atopic dermatitis(AD). It will be the first prospective study ever conducted in patients with PBC. It is hoped this study will further our understanding of cholestatic itch by identifying potential avenues for further research. This study will further our understanding of skin microbiome in PBC and the efficacy of phototherapy treatment for itch in PBC. It will also further our understanding of the effect of phototherapy on skin microbiome and will be the first study examining skin microbiome in PBC. It will also contribute to ongoing research within Newcastle University, aiming to develop an objective measurement of itch using wrist accelerometers.
Patients will receive narrowband UVB phototherapy following a standard clinical regime. Patients with PBC and atopic eczema who would have received phototherapy as part of routine clinical practice are eligible. Healthy volunteers and patients with PBC but no itch will have blood samples, urine samples, skin core biopsies and microbiome samples taken as well as fill out itch and quality of life questionnaires but will but will not be subject to phototherapy. All participants will be asked to wear wrist accelerometers to measure sleep disturbance as a proxy measure of itch and to aid in the development of an algorithm for objective itch measurement.
The study will take place at the Royal Victoria Infirmary phototherapy unit and following recruitment the study will last 10 weeks per participant receiving phototherapy. As per routine treatment, they will attend 3 times a week for 8 weeks with 1 week of pre- and post- treatment monitoring. As part of the study protocol they will be required to visit one time to the unit outside of these treatment visits. Participants not receiving phototherapy will attend the unit once during the study.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
16/NE/0408
Date of REC Opinion
26 Jan 2017
REC opinion
Further Information Favourable Opinion