Red-Light Photodynamic Therapy with 10% Aminolevulinic Acid (ALA) Following Microneedling in the Treatment of Facial Actinic Keratosis: Cosmetic and Clinical Outcomes.

Abstract

Objective: 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/cm²).

Methods: 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/cm²). 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.

Results: 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.

Limitations: The study included a small number of subjects (N=5).

Conclusion: 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.