Conflicts of interest RMS, AH, ES, ACEM, CO, MS and MB declared a conflict of interest–see note at end of article. The other authors have no conflict of interest to declare.
Long-term follow-up of photodynamic therapy with a self-adhesive 5-aminolaevulinic acid patch: 12 months data
Article first published online: 30 JUN 2009
© 2009 The Authors. Journal Compilation © 2009 British Association of Dermatologists
British Journal of Dermatology
Volume 162, Issue 2, pages 410–414, February 2010
How to Cite
Szeimies, R.-M., Stockfleth, E., Popp, G., Borrosch, F., Brüning, H., Dominicus, R., Mensing, H., Reinhold, U., Reich, K., Moor, A.C.E., Stocker, M., Ortland, C., Brunnert, M. and Hauschild, A. (2010), Long-term follow-up of photodynamic therapy with a self-adhesive 5-aminolaevulinic acid patch: 12 months data. British Journal of Dermatology, 162: 410–414. doi: 10.1111/j.1365-2133.2009.09377.x
- Issue published online: 13 JAN 2010
- Article first published online: 30 JUN 2009
- Accepted for publication 24 June 2009
- aminolaevulinic acid;
- actinic keratosis;
- photodynamic therapy
Background Photodynamic therapy with a self-adhesive 5-aminolaevulinic acid (5-ALA) patch shows high efficacy rates in the treatment of mild to moderate actinic keratosis (AK) in short term trials.
Objectives The purpose of the trial was to follow up patients after successful 5-ALA patch-PDT at 3 month intervals over a total period of 12 months. Patients who had received placebo-PDT or cryosurgery served for comparison.
Patients/methods Three months after therapy, 360 patients from two separate randomized parallel group phase III studies (one superiority trial vs. placebo-PDT, one noninferiority trial vs. cryosurgery) were suitable for the follow-up study. Patients had to show at least one successfully treated AK lesion after initial therapy. A total of 316 patients completed the follow-up.
Results Twelve months after a single treatment, 5-ALA patch-PDT still proved superior to placebo-PDT and cryosurgery (P < 0·001 for all tests). On a lesion basis, efficacy rates were 63% and 79% for PDT, 63% for cryosurgery and 9% and 25% for placebo-PDT. Recurrence rates of patch-PDT proved superior to those of cryosurgery (per protocol set: P = 0·011, full analysis set: P = 0·049). While 31% of cryosurgery lesions were still hypopigmented after 1 year, the 5-ALA patch-PDT groups showed hypopigmentation in 0% (superiority trial) and 3% (noninferiority trial) of the treated lesions.
Conclusion Twelve months after a single 5-ALA patch-PDT the majority of lesions were still cleared with an excellent cosmetic outcome. 5-ALA patch-PDT proved to be superior to cryosurgery in the noninferiority study setting.