Home- vs clinic-based daylight photodynamic therapy with 5-aminolevulinic acid nanoemulsion (BF-200 ALA) for actinic keratosis: A randomized, single-blind, prospective study.

BACKGROUND: Daylight photodynamic therapy (DL-PDT) has become one of the most effective treatments for the resolution of actinic keratosis (AK) of Olsen grade 1 and 2. Generally, PDT it is carried out in a clinic setting, which involves the patient's and their caregivers commuting to the hospital as well as a significant use of resources to carry it out within the clinic setting. OBJECTIVES: To determine the efficacy and safety of a home-based treatment of AK with DL-PDT with the BF-200 ALA gel compared to a clinic-based setting. METHODS: The study was performed as a randomized, single-center, non-inferiority clinical trial with two parallel groups. 9 patients received one clinic-based DL-PDT (group 1) and 11 patients received one session of home-based DL-PDT (group 2). The primary endpoints were the mean AK clearance per patient and the total AK lesion clearance rate 12 weeks after treatment. The secondary endpoints were the number of remaining AKs and new AKs appearing in the treatment field 12 weeks after one PDT session. The pain during and 24 h after PDT as well as the local skin reactions were also assessed. RESULTS: The overall reduction of AK lesions per patient was similar in both groups with one PDT session. An overall AK clearance per patient of 10 ± 4.33 for group 1 versus 9.73 ± 2.9 for group 2 without statistically significant differences (p = 0.868). Regarding the clearance rate, although it was slightly higher in group 2 (71.58 ± 22.51 vs 82.1 ± 11.13), the analysis did not show statistically significant differences. The mild pain recorded during the treatment course and the mild local skin reactions were similar in both groups. Patient satisfaction was high for both groups without statistically significant differences. CONCLUSION: Self-performed home-based DL-PDT with BF-200 ALA gel is as effective as the one performed in a clinic-based setting, with a comparable safety profile, high levels of patient satisfaction and with advantages for the patients and their caregivers that can enhance patient´s adherence to the treatment.

Analysis of results, quality indicators, and postsurgical complications in an outpatient dermatological surgery program.

OBJECTIVE: To evaluate the results of an outpatient program for major dermatological surgery in patients with a range of skin conditions. METHODS: We undertook a retrospective, observational study of patients who underwent scheduled dermatological surgery as outpatients in a public hospital between 2004 and 2007. The most common procedures were excision of basal cell or squamous cell carcinoma with or without graft reconstruction. The rates of substitution (of inpatient procedures), cancellation, hospital admission, and readmission were analyzed along with service utilization and systemic complications arising within the first 72 h of surgery. Variables were analyzed as relative frequencies. The occurrence of complications during the study period was analyzed by chi square test. RESULTS: A total of 2789 patients underwent surgery during the study period, and of those, 2757 procedures were performed on an outpatient basis (overall substitution rate, 17.99%). The service utilization was 74.36%. Fourteen patients were admitted to hospital following surgery (2.62%), and of those 12 were admitted immediately (85.71%). Nine patients had serious complications (cardiovascular, neurological, metabolic, or infectious), representing a proportional risk of 1:59. Less serious complications (hypertension, nausea, vomiting, and vasovagal syncope) requiring hospital admission occurred in 25 patients. CONCLUSIONS: Major surgery undertaken on an outpatient basis is an excellent multidisciplinary surgical care model that allows well-selected patients to be treated effectively, safely, and efficiently. A small percentage of postoperative complications of varying severity can still occur despite patients' meeting optimal criteria for success. Fortunately, however, the rate of mortality is practically zero.