Long-term follow-up of photodynamic therapy with a self-adhesive 5-aminolaevulinic acid patch: 12 months data.
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.


OBJECTIVE
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.


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.


CONCLUSIONS
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.
Department of Dermatology, Regensburg University Hospital, Franz Josef Strauss Allee 11, Regensburg, Germany.
R-M
RM
Szeimies
E
E
Stockfleth
G
G
Popp
F
F
Borrosch
H
H
Brüning
R
R
Dominicus
H
H
Mensing
U
U
Reinhold
K
K
Reich
A C E
AC
Moor
M
M
Stocker
C
C
Ortland
M
M
Brunnert
A
A
Hauschild
D000279:Administration, Cutaneous; D000622:Aminolevulinic Acid / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D055623:Keratosis, Actinic / Q000188:drug therapy*; D008297:Male; D010778:Photochemotherapy / Q000379:methods*; D017319:Photosensitizing Agents / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome
D017319:Photosensitizing Agents; D000622:Aminolevulinic Acid