Photodynamic therapy with 80 mg/g @entity19297 for severe XXXX : a randomised vehicle-controlled study.

@entity1 @entity5477 @entity19297 @entity7671 @entity158 @entity432
BACKGROUND: Severe @entity5477 has limited therapeutic options. OBJECTIVES: To evaluate photodynamic therapy (PDT) using topical @entity19297 ( @entity7671 , 80 mg/g) as the photosensitiser in severe facial acne METHODS: Double-blind, randomised, vehicle-controlled multicentre trial in 153 @entity1 (12-35 years) with severe facial acne (Investigator Global Assessment [IGA] score 4; 25-75 inflammatory lesions with  <=3 nodules; 20-100 non-inflammatory lesions). Treatment (4 treatments 2 weeks apart) involved incubation with @entity7671 (n=100) or vehicle cream (n=53) 1.5 hours under @entity432 , then illumination (635 nm red light, total dose 37 J/cm(2) ). IGA assessment and standardised lesion counts were performed before each treatment and 12 weeks after first treatment. Treatment success was defined as improvement from baseline in IGA by >= 2 grades at 12 weeks. Safety assessments were @entity158 (10 cm visual analogue scale [VAS], immediately after illumination), erythema (four-point rating scale) and adverse events. RESULTS: At 12 weeks, PDT using 80 mg/g @entity7671 reduced inflammatory lesions versus vehicle PDT (mean change -15.6 vs. -7.8, p=0.006; mean percent change -37.3% vs. -16.2%, p=0.003). Although non-inflammatory lesions did not decrease significantly (mean change -11.8 vs. -10.7, p=0.85; mean percent change -28.6% vs. -24.9%, p=0.72). Treatment success rates were greater with 80 mg/g @entity7671 PDT (44% vs. 26%, p=0.013). @entity158 was low and manageable by briefly pausing illumination. There was similar @entity158 or erythema with successive treatments. CONCLUSIONS: PDT using topical 80 mg/g @entity7671 and red light may offer promise for severe @entity5477 . [ClinicalTrials. gov Identifier NCT01347879; registered May 3, 2011]. This article is protected by copyright. All rights reserved.
