Clinical Pilot Study of Topical Bleosome on BCCs
Research type
Research Study
Full title
Clinical pilot study of the efficacy of topical Bleosome on Basal Cell Carcinomas.
IRAS ID
117356
Contact name
Sunil Chopra
Contact email
Sponsor organisation
SPS Healthcare Ltd
Eudract number
2005-002504-42
ISRCTN Number
n/a
Research summary
BCCs are common, slow growing skin tumours which often develop in older populations. Surgery remains the gold standard, but can be disfiguring, particularly when the tumour grows on the face. Many patients do not wish for the disfigurement that surgery causes, or are not fit for surgery due to other conditions. Left untreated the BCC will continue to grow and can invade underlying bone and tissue. A non-painful, topical formulation, which is able to eradicate the tumour would be a significant clinical development. The cancer drug Bleomycin has been used with some success for treatment of BCC, when injected directly, but this treatment is painful and technically challenging. A topical treatement would be an ideal method of drug delivery for this drug, but bleomycin is not able to penetrate the skin in standard creams. However we have found that by wrapping the bleomycin in a drug carrier called a liposome, skin absorption is greatly enhanced. Our early data on over 60 patients shows it to be highly effective and well tolerated. We wish to test this new formulation of bleomycin in a controlled clinical trial on patients with BCCs.
REC name
London - Hampstead Research Ethics Committee
REC reference
13/LO/0524
Date of REC Opinion
12 Jun 2013
REC opinion
Further Information Favourable Opinion