ABSTRACT
BACKGROUND: Photodynamic therapy (PDT) has become one of the most effective therapies for the treatment of actinic keratosis, allowing the removal of more than one lesion in a single session. However, the pain sustained by the patient during treatment and local skin reactions can limit its use. OBJECTIVES: To determine the efficacy and safety of combined PDT (daylight PDT followed by conventional PDT) vs conventional PDT 12 weeks after treatment. METHODS: The study was performed as a randomized, single-center, non-inferiority clinical trial with two parallel groups. A total of 51 patients with grade I and II AKs on the scalp or face were randomized. Twenty-five patients received one session of combined PDT (combPDT), and 26 patients received one session of conventional PDT (cPDT). The primary endpoint was the reduction of AKs, 12 weeks after treatment. The secondary endpoint was the reduction in pain and local skin reaction. RESULTS: The reduction rate of grade I and II AKs was similar in combPDT and cPDT, showing no statistically significant differences between both groups, 76.67% vs 86.63% [P = .094] and 80.48% vs 83.08% [P = .679], respectively. However, pain was significantly lower in the combPDT group (2.56 vs 5, P < .01), as were local skin reactions. CONCLUSIONS: CombPDT has proven to be as effective as cPDT for the treatment of grade I and II AKs located on the scalp and face. Furthermore, combPDT has been shown to be considerably more tolerable than cPDT, causing only mild local skin reactions.
Subject(s)
Keratosis, Actinic , Photochemotherapy , Aminolevulinic Acid/adverse effects , Aminolevulinic Acid/analogs & derivatives , Humans , Keratosis, Actinic/pathology , Pain/etiology , Photochemotherapy/adverse effects , Photosensitizing Agents/adverse effects , Prospective Studies , Single-Blind Method , Treatment OutcomeABSTRACT
Photodynamic therapy (PDT) is an effective treatment option for the treatment of superficial basal cell carcinoma (sBCC). Recent publications have demonstrated that PDT with 7.8% 5-aminolaevulinic acid nanoemulsion-based gel (BF-200 ALA-PDT) is an effective and safe alternative for the treatment of sBCC). To investigate the efficacy and safety of 7.8% 5-aminolaevulinic acid nanoemulsion-based gel (BF-200 ALA)-PDT for the treatment of sBCC. A non-controlled, open-label single centre study was conducted. Patients received one PDT cycle with two PDT sessions one-week apart. In case that clinical-dermoscopy evaluation of treatment outcome revealed remaining lesions, a second PDT cycle was performed. The clinical results at the dermoscopy and fluorescence diagnosis level were histologically confirmed in all patients. Treatment response was evaluated 3, 6, and 12 months after last PDT session. A total of 31 patients (12 men and 19 women), with a median age of 63.74 years were included in this study. 3-month after PDT-session, 23/31 patients were complete responders (74.19%) after two BF-200 ALA -PDT sessions. Esthetic outcome was considered good-to-excellent. 5 Aminolevulinic acid 7.8% nanoemulsion-based gel (BF-200 ALA) PDT is an effective therapy option for the treatment of sBCC. Complete clearance rates were higher in those patients who received only one PDT cycle. These results show a similar tendency as shown in other publications.
