CLINICAL TRIAL
JOURNAL ARTICLE
RESEARCH SUPPORT, NON-U.S. GOV'T
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A trial of short incubation, broad-area photodynamic therapy for facial actinic keratoses and diffuse photodamage.

BACKGROUND: There is no completely satisfactory treatment for multiple actinic keratoses (AKs).

OBJECTIVE: To evaluate the efficacy of short incubation, broad-area application of delta-aminolevulinic acid followed by exposure to activating light-photodynamic therapy (delta-ALA/PDT) for treatment of AKs and background photodamage. The benefit of pretreatment with 40% urea cream to enhance penetration and the use of topical 3% lidocaine hydrochloride to decrease discomfort were also evaluated.

METHODS: Eighteen patients with at least 4 nonhypertrophic facial AKs and mild to moderate diffuse facial photodamage were enrolled in the study. For 7 days, 40% urea cream or vehicle was applied to half of the treatment area, and then delta-ALA was applied to the entire area for 1, 2, or 3 hours. Lidocaine hydrochloride (3%) or vehicle cream was also applied to the entire area 45 minutes before exposure to 10 J/cm(2) of blue light. Pain,phototoxic reactions, AK counts, and photodamage improvement were evaluated 1 day, 1 week, and 1 month after treatment in all patients and after 5 months in 10 patients.

RESULTS: All patients experienced mild to moderate discomfort during treatment and moderate phototoxic effects for 1 week. At 1 and 5 months there was significant reduction in AKs in all groups and significant improvement of several photodamage parameters. Different delta-ALA application times and pretreatment with urea cream or lidocaine had no significant effect on the results.

CONCLUSIONS: This delta-ALA/PDT protocol is safe and effective for AK treatment as well as for improving photodamage. Further studies with a larger cohort, longer follow-up, and histologic confirmation of the clinical data would be of value.

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