Clinical Trial Centres and Study Investigators
1. Dr R Cerio
The Royal London Hospital
2. Professor A Finlay
University of Wales College of Medicine
3. Dr R A C Graham-Brown
Leicester Royal Infirmary
4. Dr J Hawk
St Thomas Hospital
5. Dr M Rustin
Royal Free Hospital
6. Dr D L Roberts
7. Dr P Kersey
8. Professor C E M Griffiths
9. Dr L J Cook
St Mary's Hospital, Portsmouth
10. Dr G R Sharpe
Royal Liverpool Hospital, Liverpool
Dermatologist Phase 3 Clinical Trials and Open Studies U.K Hospitals, 2002
The clinical trial experience has shown that the BEC was safe. The dermatologists who conducted the Phase III clinical trials with BEC 5
concluded that BEC5 is a topical preparation, which is safe and effective. BEC 5
therapy is ideal for outpatient treatment and is a much needed alternative to
surgery for BCC. The clinical trials of BEC5 done by the multi-centres, comprised of application of BEC5 twice daily for eight weeks.
Phase III clinical trials involving ten centres in the United Kingdom were
completed in 2002. The general success rate of the glycoalkaloid (BEC) cream was 78 percent. Longer duration therapy with BEC would have resulted in higher success rates. These results were comparable to Clincal Trials 1 & 2 andindependent doctor studies into Curaderm previously obtained over the last 20 years.
A subsequent open study trial carried out at the Dermatology Department at the Royal London Hospital it was also shown that the glycoalkaloid cream was effective on morpheoic BCC lesions, which are a type of invasive BCC.
Royal London has a large dedicated skin cancer clinic as it is a Skin Cancer Center for
the North East Thames Network. This fact, coupled with the results of the first trial, was
instrumental on Royal London's conduct of second open study. Success rates in this open
trial paralleled the multi-center efficacy rate of 78%. Success was defined as zero
presence of basal cell carcinoma after histological examination of samples extracted from
the lesion site by punch biopsy.
We consider that this rate of treatment success more than justifies the physician
considering BECs as an alternative to currently predominant treatment such as surgical
excision or cryotherapy.
BEC results in ulceration of the lesion site during treatment. However, we have observed
that post treatment the wound is quick replenished with normal tissue and that residual
scarring is minimal. Whether such scarring proves more or less extensive than that
consequent upon a number of factors including lesion size, location and so on. However,
it can be said that the cosmetic results offered by treatment with BEC5 are comparable to
that resulting from surgical excision.
Basal Cell Carcinoma is a slow growing locally inavasive malignant skin tumor which
mainly affects Caucasians. Dermotologists, plastic surgeons and radiotherapists jointly
manage the affliction, such management usually involves surgery. The risks of surgical
intervention are well known.
Moreover, excision of basal cell carcinoma from the facial area often involves
reconstructive, oowhich can be both time consuming and costly. Hence an alternative,
safe and efficacious method of treatment of basal cell carcinoma that does not require
physician or hospital attendance must be encouraged.
In our view and experience BEC5 is a tropical preparation, which is safe and effective,
ideal therapy for outpatient treatment. Hence BEC5 is a much needed alternative to
surgery for basal cell carcinoma. This is the commonest cancers in Caucasians worldwide
and the prevelence continues to increase with an increasing ageing population.
It is a cost effective treatment for both primary and secondary skin cancer care.