Photodynamic therapy with aminolevulinic acid topical solution and visible blue light in the treatment of multiple actinic keratoses of the face and scalp: investigator-blinded, phase 3, multicenter trials.
OBJECTIVE
To determine the safety and efficacy of photodynamic therapy (PDT) using 20% wt/vol aminolevulinic acid hydrochloride (hereinafter "ALA") and visible blue light for the treatment of multiple actinic keratoses of the face and scalp.


METHODS
Randomized, placebo-controlled, uneven parallel-group study.


METHODS
Patients (N = 243) were randomized to receive vehicle or ALA followed within 14 to 18 hours by PDT. Follow-up visits occurred 24 hours and 1, 4, 8, and 12 weeks following PDT. Target lesions remaining at week 8 were re-treated.


METHODS
Clinical response based on lesion clearing by week 8.


RESULTS
Most patients in both groups had 4 to 7 lesions. Complete response rates for patients with 75% or more of the treated lesions clearing at weeks 8 and 12 were 77% (128/166) and 89% (133/149), respectively, for the drug group and 18% (10/55) and 13% (7/52), respectively, for the vehicle group (P<.001, Cochran-Mantel-Haenszel general association test). The 95% confidence interval for the difference in response rates at week 8 was 46.9% to 71.0% and at week 12, 65.3% to 86.3%. The week 12 response rate includes 30% of patients who received a second treatment. Most patients experienced erythema and edema at the treated sites, which resolved or improved within 1 to 4 weeks after therapy, and stinging or burning during light treatment, which decreased or resolved by 24 hours after light treatment.


CONCLUSIONS
Findings indicate that topical ALA PDT is an effective and safe treatment for multiple actinic keratoses of the face and scalp.
Piacquadio
Daniel J
DJ
Division of Dermatology, Department of Medicine, University of California, San Diego, USA. danp@therapeuticsinc.com
Chen
Diana M
DM
Farber
Harold F
HF
Fowler
Joseph F
JF
Glazer
Scott D
SD
Goodman
J John
JJ
Hruza
Luciann L
LL
Jeffes
Edward W B
EW
Ling
Mark R
MR
Phillips
Tania J
TJ
Rallis
Tena M
TM
Scher
Richard K
RK
Taylor
Charles R
CR
Weinstein
Gerald David
GD
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000622:Aminolevulinic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D005148:Facial Dermatoses / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007642:Keratosis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D019999:Pharmaceutical Solutions; D010778:Photochemotherapy / Q000009:adverse effects / Q000379:methods; D017319:Photosensitizing Agents / Q000008:administration & dosage* / Q000009:adverse effects; D012536:Scalp Dermatoses / Q000188:drug therapy*; D016037:Single-Blind Method
D019999:Pharmaceutical Solutions; D017319:Photosensitizing Agents; D000622:Aminolevulinic Acid