PhotoCures multicenter study (phase II) for pre-cancerous actinic keratosis (AK) lesions has taken place at 7 university hospitals in 6 European countries and results from the 3 months follow-up of this study are reported below.
In this multicenter study the Metvix cream at two concentrations (80 mg/g and 160 mg/g) is applied on the skin for either 1 or 3 hours before illumination with red light. A total of 112 patients with a total of 384 lesions of AK were treated. Approximately 60% of the patients were treated once, whereas the rest received 2 treatments. 79 – 90% of the patients revealed complete response and the response rate was depended on application time and dose of Metvix. Metvix 160 mg/g for 3 hours was the treatment giving highest complete response.
The cosmetic results from this study was excellent for all the treatment groups. Only few and expected side effects such as slight redness, burning sensation, or slight pain during the treatment were observed. No general or serious side effects related to the treatments have been reported. The investigation concludes that Metvix PDT is effective in AK and provide excellent cosmetic results and few side effects. Because Metvix 160 mg/g applied on the skin for 3 hours appears to give the highest response rates in AK, PhotoCure has used this dosage regimen in the comparative phase III studies which now are being completed.
PhotoCure plans to send a European registration file for Metvix PDT for AK during this year and data on treatment effects and side effects from this phase II study will form an important part of the documentation.
Professor Lasse Braathen from Bern, Switzerland who has co-ordinated this clinical investigation and who also has participated in PhotoCure’s other clinical trials on skin cancer (Basal Cell Carcinoma), say’s that this type of treatment may represent first line treatment for both skin cancer and Actinic Keratosis in the future. He plans to present the results to the meeting in European Academy of Dermatology and Venerology (EADV) in Geneva later this year. The results from this study will also be published in an international journal in dermatology.