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 and
independent doctor studies into Curaderm previously obtained over the last
20 years.
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
Singleton Hospital
7. Dr P Kersey
Derriford Hospital
8. Professor C E M Griffiths
Hope Hospital
9. Dr L J Cook
St Mary's Hospital, Portsmouth
10. Dr G R Sharpe
Royal Liverpool Hospital, Liverpool
By Using Curaderm YOU DO NOT NEED Surgery, Radiotherapy or other Conventional Methods
Plastic surgeons, radiotherapists and dermatologists jointly manage BCCs, which are slow growing, locally invasive malignant skin tumors.
To date such management usually involves surgery. It must also be stressed that the risks of surgical intervention are well known. Moreover, excision of BCC from the facial area often involves reconstructive surgery, which can be both time consuming and costly.
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.
Tens of Thousands NO longer need to Loose Skin and Body Parts. Curaderm has
Clinical Proven Effectiveness.
Following two decades Dr. Cham's group first reported the efficacy and safety of BEC01 and Curaderm for the treatment of non malignant and invasive malignant skin cancer, the skin specialists who conducted the clinical trials have realized the true benefits of Curaderm.
Tens of thousands of patients have unnecessarily lost their noses, eyes, ears, and some even their lives, because Curaderm cream was not recommended for use! The definite outcome to having an effective treatment for skin cancer using a cream is now about allowing the general public to benefit from Curaderm's real value for patients.
The clinical trial experience has shown that the BEC was safe. Only local
skin irritation and erythema (reddening) occurred during treatment. Success
was defined as zero presence of basal cell carcinoma after histological (microscopic)
examination of samples removed from the lesion sites by punch biopsy. Two
applications per day of BEC to the cancer lesions resulted in ulceration of
the lesion sites during treatment. However, it was observed that post treatment
the wound was quickly replenished with normal tissue and that residual scarring
was minimal.
CLINICAL APPRAISAL ON RESULTS FROM PHASE III Clinical Trials and OPEN STUDIES
FROM ROYAL LONDON HOSPITAL
Dr Sangeeta Punjabl
MBBS DVD DipNB (Dermatology)
Research Registar, Royal London Hospital
Rino Cerio
BScFgRCP (Lond) FRCP (Edin)
Consultant Dermotologist and Senior Lecturer in Dermatopathology
Background
The Dermatology Department at the Royal London Hospital has acted as an approved and designated center in two clinical trials to determine the safety and efficacy of BEC 5 cream in the treatment of cancerous lesions of the skin. In the first of these, a pivotal double blind randomized study, Royal London recruited, treated and monitored 21 of the 94 patients. In the second trial, comprising 41 patients, Royal London was the sole designated centre. This trial was an open study, conducted primarily assess the safety of the product. Herewith we summarize our observation on the use, safety, efficacy, cosmetic result and resource effectiveness of the product.
USE
The Dermatology Department at the Royal London Hospital has acted as an approved and designated center in two clinical trials to determine the safety and efficacy of BEC 5 cream in the treatment of cancerous lesions of the skin. In the first of these, a pivotal double blind randomized study, Royal London recruited, treated and monitored 21 of the 94 patients. In the second trial, comprising 41 patients, Royal London was the sole designated centre. This trial was an open study, conducted primarily assess the safety of the product. Herewith we summarize our observation on the use, safety, efficacy, cosmetic result and resource effectiveness of the product.
In our view these results, in the least justify a more extensive clinical trial of BEC5 against such cancers. We note in this respect that treatment of the morpheoic form of the affliction is presently confined to surgical removal. We are not aware of any emerging therapy, for example, photodynamic therapy that has the potential to extend to treatment of other than superficial skin cancers.
Safety
Our clinical experience has shown that BEC5 is safe. In the two frequent (twice daily) and prolonged (8 weeks) application of a cream incorporating BEC5 under occlusive dressing resulted only in local skin irritation and erythema. Very few patients under our supervision withdrew from treatment on this account. Hence we consider treatment with BEC5 to be safe therapy.
Furthermore, patient blood and urine was analyzed using very sensitive methods to determine the presence of the BEC5 during and after a standard treatment regime (twice daily for 8 weeks). Such analysis product no evidence of the active pharmaccutical ingredients to BEC5 or their breakdown products. Hence, it was concluded that there is no systemic absorption of BEC5. This is extremely important from the clinical perspective and may be contrasted with other topical preparations. For example, 5 fluouracil shows systemic absorption and can prove to toxic when used with large lesions.\
Efficacy
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.
Cosmetic Evaluation
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.
Resource Effectiveness
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.
