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Photodynamic Therapy With Aminolevulinic Acid Topical Solution andVisible Blue Light in the Treatment of Multiple Actinic Keratoses of the Faceand Scalp: Investigator-Blinded, Phase 3, Multicenter Trials
Abstract
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.
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“A phase III clinical trial of ALA/PDT for the treatment of multiple AKs of the face and scalp found 89% of patients had 75% or more of their AKs treated by week 12 [39].”
From Photodynamic Therapy for Non-Melanoma Skin Cancers (2016) · cites this paper as [39]
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Metadata
- Authors
- Piacquadio, D. J., Chen, D. M., Farber, H. F., Fowler, Jr., Glazer, S. D., Goodman, J. J., Hruza, L. L., Jeffes, E. W. B., Ling, M. R., Phillips, T. J., Rallis, T. M., Scher, R. K., Taylor, C. R., & Weinstein, G. D.
- Affiliations
- University of California San Diego (US)
- Venue
- Archives of Dermatology
- Publisher
- American Medical Association (AMA)
- Published
- 2004-01-01
- Volume
- 140
- Issue
- 1
- Pages
- 41-6
- ISSN
- 0003-987X (ISSN-L)
- OpenAlex
- W2121308368
- Cited by
- 239
- References
- 19
- Citations by year
- 2026: 1 · 2025: 5 · 2024: 4 · 2023: 11 · 2022: 7 · 2021: 9 · 2020: 8 · 2019: 10 · 2018: 13 · 2017: 10 · 2016: 14 · 2015: 16 · 2014: 12 · 2013: 6 · 2012: 11
- FWCI
- 9.34
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Archives of Dermatology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Dermatology › Nonmelanoma Skin Cancer Studies
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Photodynamic Therapy Research Studies
- Health Sciences › Medicine › Dermatology › Skin Protection and Aging
- Keywords
- photodynamic therapy, 5-aminolevulinic acid, actinic keratosis, facial skin lesions, scalp lesions, topical photosensitizer, treatment efficacy, treatment safety, erythema and edema
- MeSH terms
- Administration, Topical, Adult, Aged, Aged, 80 and over, Aminolevulinic Acid, Facial Dermatoses, Female, Humans, Keratosis, Male, Middle Aged, Photochemotherapy, Scalp Dermatoses, Single-Blind Method, Photosensitizing Agents, Pharmaceutical Solutions
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