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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
Daniel J. Piacquadio, MD;
Diana M. Chen, MD;
Harold F. Farber, MD;
Joseph F. Fowler, Jr, MD;
Scott D. Glazer, MD;
J. John Goodman, MD;
Luciann L. Hruza, MD;
Edward W. B. Jeffes, MD;
Mark R. Ling, MD, PhD;
Tania J. Phillips, MD;
Tena M. Rallis, MD;
Richard K. Scher, MD;
Charles R. Taylor, MD;
Gerald David Weinstein, MD
Arch Dermatol. 2004;140:41-46.
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.
Design Randomized, placebo-controlled, uneven parallel-group study.
Interventions 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.
Main Outcome Measure 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.
Conclusion Findings indicate that topical ALA PDT is an effective and safe treatment for multiple actinic keratoses of the face and scalp.
From the Division of Dermatology, Department of Medicine, University of California, San Diego (Dr Piacquadio), Northwestern University, Chicago, Ill (Dr Chen); Departments of Dermatology, University of California, Irvine (Drs Jeffes and Weinstein), Boston University, Boston, Mass (Dr Phillips), Massachussetts General Hospital, Boston (Dr Taylor), University of Utah, Salt Lake City (Dr Rallis), Columbia University, New York, NY (Dr Scher); Divisions of Dermatology, University of Louisville School of Medicine, Louisville, Ky (Dr Fowler), Washington University School of Medicine, St Louis, Mo (Dr Hruza); and Radiant Research, West Palm Beach, Fla (Dr Goodman); Medaphase Inc, Atlanta, Ga (Dr Ling). Drs Farber and Glazer are in private practice in Philadelphia, Pa, and Buffalo Grove, Ill, respectively. Dr Chen is now with Abbott Laboratories, Abbott Park, Ill. Dr Goodman's affiliation, Radiant Research, was formerly known as Hilltop Research. The authors have no relevant financial interest in this article.
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