Goldenberg Gary, Schwartz Ziv, Yousefian Faraz
Dr. Goldenberg is with the Icahn School of Medicine at Mount Sinai Hospital, Department of Dermatology in New York, New York.
Dr. Schwartz is with Sidney Kimmel Medical College at Thomas Jefferson University, Department of Dermatology and Cutaneous Biology in Philadelphia, Pennsylvania.
J Clin Aesthet Dermatol. 2025 Apr;18(4):51-56.
We evaluated the cosmetic outcome and clearance of actinic keratoses (AKs) using photodynamic therapy (PDT) with microneedling-assisted delivery of 10% aminolevulinic acid (ALA) gel (Ameluz®, Biofrontera, Woburn, MA) with 30-minute incubation followed by 10-minute illumination with a red light (BF-RhodoLED®, 635nm, 37 J/cm).
Five subjects were treated with red light PDT using microneedling-assisted delivery of 10% ALA gel. ALA gel was applied on the face and incubated for 30 minutes without occlusion, followed by illumination with a red light for 10 minutes (635nm, 37 J/cm). Follow-up (FU) visits were made at Weeks 1, 2, 4, and 8. The primary endpoints were changes in subject- and investigator-graded Global Aesthetic Improvement Scale (GAIS) scores and assessment of quality in wrinkle, color evenness, texture, spot, and pore analyses with Canfield Visia-CR imaging system. Secondary endpoints were: 1) AK clearance as quantified by the count of AKs at eight-week FU versus baseline and 2) safety as measured by subject-reported pain (10-point VAS scale) during red-light illumination and adverse events.
Investigator- and subject-graded GAIS scores showed a sharp increase to "much improved" at two weeks and increased to "very much improved" at eight weeks. There was an average 24.93-percent improvement in texture and an average 10.30-percent improvement in skin tone (color) evenness. AK lesion clearance ranged from 70 to 100 percent, with the mean at 89.2±14.9 percent. Three subjects achieved 100-percent clearance. The mean pain score during red-light illumination was 3.2±1.6. All subjects completed the study.
The study included a small number of subjects (N=5).
Our results indicate that red light PDT using microneedling-assisted delivery of 10% ALA gel and a short 30-minute incubation is a safe and tolerable procedure producing good cosmetic outcomes in several skin quality parameters, such as texture and skin tone evenness, as well as an AK lesion clearance rate of 89.2 percent at Week 8, relatively low pain scores, and a reduced PDT treatment time.
我们评估了采用微针辅助递送10%氨基酮戊酸（ALA）凝胶（Ameluz®，Biofrontera公司，马萨诸塞州沃本）进行光动力疗法（PDT）治疗光化性角化病（AK）的美容效果和清除情况，ALA凝胶孵育30分钟后用红光（BF-RhodoLED®，635nm，37J/cm²）照射10分钟。
5名受试者接受了使用微针辅助递送10%ALA凝胶的红光PDT治疗。将ALA凝胶涂抹于面部，不封闭孵育30分钟，随后用红光照射10分钟（635nm，37J/cm²）。在第1、2、4和8周进行随访（FU）。主要终点是受试者和研究者评定的全球美学改善量表（GAIS）评分的变化，以及使用Canfield Visia-CR成像系统对皱纹、肤色均匀度、质地、斑点和毛孔分析的质量评估。次要终点为：1）通过八周随访时AK的计数与基线相比量化的AK清除情况，以及2）通过受试者报告的红光照射期间的疼痛（10分视觉模拟量表）和不良事件衡量的安全性。
研究者和受试者评定的GAIS评分在两周时急剧上升至“明显改善”，在八周时上升至“非常明显改善”。质地平均改善24.93%，肤色（颜色）均匀度平均改善10.30%。AK病变清除率在70%至100%之间，平均为89.2±14.9%。三名受试者实现了100%清除。红光照射期间的平均疼痛评分为3.2±1.
