Serini Stefano Maria, Cannizzaro Maria Vittoria, Dattola Annunziata, Garofalo Virginia, Del Duca Esther, Ventura Alessandra, Milani Massimo, Campione Elena, Bianchi Luca
Outpatient Dermatology Service Milan, Milan, Italy.
Dermatology, University of Rome Tor Vergata, Rome, Italy.
J Cosmet Dermatol. 2019 Feb;18(1):156-162. doi: 10.1111/jocd.12670. Epub 2018 May 22.
Acne vulgaris is a chronic inflammatory skin disease, commonly treated with topical or systemic drugs, according to the severity of the condition. Retinoids and antibiotic compounds are considered cornerstone approaches in this condition. However, low adherence to the therapy and the issue of bacterial resistance undermine the efficacy in the long term. Photodynamic therapy (PDT) with 20% aminolevulinic acid (ALA) has shown to be effective in the treatment of inflammatory acne. Skin tolerability, however, could be a limiting factor for a widespread use of this approach. A new formulation of 5% ALA in thermosetting gel has been recently available. This formulation allows a more convenient application procedure without occlusion and better and more efficient release of the active compound in comparison with traditional ALA formulations like creams or ointments.
To evaluate in a two-center, assessor-blinded, prospective, proof-of-concept study, the efficacy, and tolerability of red-light (630 nm) PDT with a new 5-ALA "low-dose" topical gel formulation (5%) in the treatment of inflammatory mild-to-moderate acne vulgaris (AV).
A total of 35 subjects with moderate AV of the face (mean age: 24 ± 8 years, 13 men and 22 women) were enrolled, after their written informed consent. The primary outcome was the evolution of GAG (Global Acne Grade System) score at baseline and after an average of three, 630-nm, 15-minute, PDT sessions, performed every 2 weeks. GAG score was also calculated in a follow-up visit 6 months after the last PDT session. Skin tolerability was assessed during PDT sessions with a patient-reported discomfort level evaluation score from 0 (no discomfort at all) to 3 (severe discomfort).
At baseline, the GAG score was 21 ± 6. After the last PDT session, the GAG score evaluated in a blinded fashion (digital photographs) was significantly reduced to 6.5 ± 5.7, representing a 70% reduction (P = .0001, Wilcoxon test; mean difference 14.9; 95% CI of the difference: 12.1-17.6). At the follow-up visit, the GAG score was 6.7 ± 6.8. The 5% ALA thermosetting gel Red-light PDT was in general very well tolerated with a discomfort mean level score of 0.5 ± 1.
This proof-of-concept study supports the efficacy of 5% ALA thermosetting gel red-light PDT in inflammatory acne of the face with a relevant clinical improvement of inflammatory lesions with a very good tolerability profile. Clinical improvement was maintained in the medium term (Trial Registration Number: ISRCTN66066651).
寻常痤疮是一种慢性炎症性皮肤病，通常根据病情严重程度采用局部或全身用药治疗。维甲酸类药物和抗生素化合物被认为是治疗该病的基础方法。然而，治疗依从性低和细菌耐药问题长期影响疗效。20% 氨基酮戊酸（ALA）光动力疗法（PDT）已被证明对炎性痤疮有效。然而，皮肤耐受性可能是该方法广泛应用的限制因素。一种新型的5% ALA热固性凝胶制剂最近已上市。与传统的ALA制剂如乳膏或软膏相比，该制剂使用更方便，无需封闭，且活性化合物释放更好、更有效。
在一项双中心、评估者盲法、前瞻性概念验证研究中，评估新型5-ALA“低剂量”局部凝胶制剂（5%）的红光（630nm）PDT治疗轻度至中度寻常痤疮（AV）的疗效和耐受性。
经书面知情同意后，共纳入35例面部中度AV患者（平均年龄：24±8岁，男性13例，女性22例）。主要结局指标是基线时以及平均每2周进行一次、每次15分钟、共三次630nm PDT治疗后全球痤疮分级系统（GAG）评分的变化。在最后一次PDT治疗后6个月的随访中也计算GAG评分。在PDT治疗期间，通过患者报告的不适程度评估评分（从0分（完全无不适）到3分（严重不适））评估皮肤耐受性。
基线时，GAG评分为21±6。在最后一次PDT治疗后，以盲法（数码照片）评估的GAG评分显著降至6.5±5.7，降低了70%（P = .0001，Wilcoxon检验；平均差异14.9；差异的95% CI：12.1 - 17.6）。在随访时，GAG评分为6.7±6.8。5% ALA热固性凝胶红光PDT总体耐受性良好，不适平均评分为0.5±1。
这项概念验证研究支持了用5% ALA热固性凝胶红光PDT治疗面部炎性痤疮的疗效，炎性皮损有显著临床改善，耐受性良好。中期维持了临床改善（试验注册号：ISRCTN66066651）。
