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. Archives of dermatology. [Arch Dermatol] Journal article | | Title | 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. | | Author(s) | Piacquadio DJ, Chen DM, Farber HF, Fowler JF, Glazer SD, Goodman JJ, Hruza LL, Jeffes EW, Ling MR, Phillips TJ, Rallis TM, Scher RK, Taylor CR, Weinstein GD | | Institution | Division of Dermatology, Department of Medicine, University of California, San Diego, USA. danp@therapeuticsinc.com | | Source | Arch Dermatol 2004 Jan; 140(1):41-6. | | MeSH | Administration, Topical
Adult
Aged
Aged, 80 and over
Aminolevulinic Acid
Facial Dermatoses
Female
Humans
Keratosis
Male
Middle Aged
Pharmaceutical Solutions
Photochemotherapy
Photosensitizing Agents
Research Support, Non-U.S. Gov't
Scalp Dermatoses
Single-Blind Method
| | 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. | | Language | eng | | Pub Type(s) | Clinical Trial
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
| | PubMed ID | 14732659 |
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