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 (PϽ.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.
Summary
Background The safety of topical therapies for atopic dermatitis (AD), a common and morbid disease, has recently been the focus of increased scrutiny, adding confusion as how best to manage these patients.
Objectives The objective of these systematic reviews was to determine the safety of topical therapies for AD.
Methods Databases searched included: OVID Medline, Medline In‐Process and Other Non‐Indexed Citations, Embase, and the Cochrane Central Register of Controlled Trials. In addition to the articles identified by this search, investigators were also referred to a list of links (most recently updated 25 September 2005) to recent Food and Drug Administration (FDA) studies, reports and meetings regarding the topical calcineurin inhibitors for further potential references. Only fully published papers available in English and data obtained from FDA sites were included. Furthermore, the criteria for inclusion and exclusion for each systematic review were further evaluated at a meeting of all of the content and evidence‐based medicine experts participating in this process and alteration of the inclusion criteria was done at that time when it was felt necessary to avoid inclusion of lower‐quality data in the review. Qualitative review of the abstracted data was performed and reviewed at a meeting of all of the content and evidence‐based medicine experts.
Results While systemic exposure to these topical agents does occur, physiological changes appear to be uncommon and systemic complications rare and have only been found with use of topical corticosteroids.
Conclusions Based on the data that are available the overall safety of AD therapies appears to be good with the only documented systemic side‐effects of therapy those occasionally seen with use of topical corticosteroids.
Eflornithine is safely used in conjunction with laser hair removal treatments and promotes more rapid hair removal when combined with laser treatment. Patients demonstrate a clear preference for treatment with laser and eflornithine.
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