Background
The Dermatology Department at the Royal London Hospital has acted as an approved and designated centre in two clinical trials to determine the safety and efficacy of BEC5 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 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 fact have invasive 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 i.e. 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.

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 analysed 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 toxic when used with large lesions.

Efficacy
Royal London has a large dedicated skin cancer clinic as it is a Skin Cancer Centre 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-centre 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
BEC5 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.

Dr Ross Evans conducted two projects. Project 1 was on small tumors. He treated over 500 such tumors. Project 2 was on larger tumors. The period of his studies extended over five years. Dr Evans established that all tumors treated with Curaderm totally regressed with no recurrences in any of the lesions he was able to follow up. He observed that the period of treatment was completed when the pain experienced after each application of Curaderm suddenly diminished or actually ceased. Dr Evans concluded that he was very impressed with the cosmetic effects resulting from treatment of the tumors with Curaderm. In many cases neither the patient nor Dr Evans was able to accurately recall the exact site of the lesion treated. Other than mild pain, the patients had no side effects.

Dr Roy Goodman treated 61 lesions with Curaderm over two years. He summarized by stating that in his experience Curaderm was effective when used as directed and was most useful on the face where an excellent cosmetic result usually occurred. This was particularly true around the nose and mouth where cosmetic surgery would be most obvious.

Dr Kevin Dallimore, an Australian dermatologist, who had an unbiased open approach when using Curaderm, studied seven patients with various lesions. He concluded that his results suggested that Curaderm cream maybe promising for the lesions treated but it would require follow up most likely over a period of five years before one could say how effective it had actually been, especially in terms of recurrences.

Of course other studies, in which the patients had been followed up for over a decade after Curaderm treatment, established that there were no recurrences. This satisfied user of Curaderm wrote to Dr Cham after successful and painless treatment with Curaderm.

With the increasing number of people using Curaderm to cure their skin cancer we will publish more letters that we have received from satisfied users.