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Curaderm Clinical Trial

United Kingdom Hospitals Dermatologist Clinical Trial

NOTE: This is a copy of the clinical evaluation of Curaderm BEC5.
Barts And The London NHS - NHS Trust

Dermatology Department 2nd Floor Outpatient Building
Hospital White Chapel London, E1 1BB

Tuesday April 23rd 2002


You have requested us to detail our clinical experience with BEC5 in the treatment of malignant lesions of the skin. We understand that this may be shown to potential purchasers of BEC5.


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.


The trials were formally restricted to patients diagnosed by physician as having superficial basal cell carcinoma. Hence patients with morpheoic lesions were excluded. However subsequently conducted punch biopsy results demonstrated that several trial patients did in deed have basal cell carcinoma. Even so our findings in respect of these patients were that successful treatment of the invasive form of basal cell carcinoma paralleled the general success rate of BEC5 ie, around 78%.

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.


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 produced no evidence of the active pharmaceutical 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 be toxic when used with large lesions.


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 BEC5 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 quickly replenished with normal tissue and that residual scarring is minimal. Whether such scarring proves more or less extensive than that consequent upon surgical excision is dependant on 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 invasive malignant skin tumor which mainly affects Caucasians. Dermatologists, 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, which 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 topical 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 cancer in Caucasians worldwide and the prevalence continues to increase with an increasing ageing population. It is a cost effective treatment for both primary and secondary skin cancer care.

We trust that the following is adequate for your purposes

Yours Sincerely,

Rino Cerio BS (Lond) FRCP (Edin) FRCPath Consultant Dermatologist and Senior Lecturer in Dermatopathology

Dr. Sangeeta Punjabi MBBS, DVD, DipNB (Dermatology) Research Registrar, Royal London Hospital