Radiation Induced Skin Reaction Study IBRB-02
Research type
Research Study
Full title
SINCERE: A single-centre, assessor blind, randomised pilot study to evaluate the safety, tolerability and acceptability of RB Lotion compared to standard-of-care for Radiation Induced Skin Reactions (RISR), in subjects undergoing palliative external beam Radiotherapy (RT).
IRAS ID
180864
Contact name
Gerard Hanna
Contact email
Sponsor organisation
Dermal Laboratories Ltd
Eudract number
2015-002258-10
Duration of Study in the UK
0 years, 6 months, 19 days
Research summary
The main purpose of this study is to assess whether RB Lotion is safe for use by patients who are undergoing palliative Radiotherapy (RT) for their cancer. The most common side effect of radiotherapy treatment is a skin reaction, known as Radiation Induced Skin Reaction (RISR) which can become painful and cause damage to the skin. In order to help prevent or reduce the effects of these skin reactions, in standard care, patients undergoing RT are provided with a lotion or cream to apply to the area of the skin where the RT is received.
In this study, eligible patients will receive both RB Lotion and standard of care, Diprobase Cream, to apply to assigned halves of their RT treatment site during their RT treatment. Participants will be instructed to use these treatments for up to a further 7 weeks if skin reactions (RISR) are still present. Safety will be evaluated by measuring and studying the difference in the grade of skin reaction between RB Lotion and Diprobase cream during the study.
This study will also evaluate outcomes and treatment acceptability of RB Lotion compared to standard of care for RISR.
REC name
HSC REC B
REC reference
16/NI/0176
Date of REC Opinion
20 Sep 2016
REC opinion
Favourable Opinion