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Cited by 239Nonmelanoma Skin Cancer StudiesPhotodynamic Therapy Research StudiesSkin Protection and Aging

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

Piacquadio, Daniel J., Chen, Diana M., Farber, Harold F., Fowler, Jr, Joseph F., Glazer, Scott D., Goodman, J. John, Hruza, Luciann L., Jeffes, Edward W. B. +6 more·2004·Archives of Dermatology
DOI 10.1001/archderm.140.1.41
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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.

    “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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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)
ORCID
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)
DOI
10.1001/archderm.140.1.41
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 › Epidemiology › Nonmelanoma Skin Cancer Studies
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › 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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