The use of 5-aminolevulinic acid (ALA) 5% thermosetting gel red-light photodynamic therapy (PDT) for the treatment of inflammatory acne of the face is associated with clinical improvement of inflammatory lesions with a favorable tolerability profile, according to the results of a 2-center, prospective, assessor-blinded, proof-of-concept study conducted at outpatient clinics in Italy. Study findings were published in the Journal of Cosmetic Dermatology.

The investigators sought to evaluate the efficacy, safety, and tolerability of red-light (630 nm) PDT with a new 5-ALA “low-dose” topical gel formulation (5%) for the treatment of patients with inflammatory mild to moderate acne vulgaris. A total of 35 participants with moderate acne vulgaris of the face were enrolled in the study. The mean patient age was 24±8 years; 22 women and 13 men participated.

The primary study outcome was evolution of the Global Acne Grade System (GAG) score at baseline and after an average of three 630-nm, 15-minute PDT sessions, which were conducted every 2 weeks. Patients’ GAG score was also calculated in a 6-month follow-up visit after the last PDT session. Skin tolerability was evaluated during the PDT sessions, with a patient-reported discomfort level score from 0 (defined as no discomfort at all) to 3 (defined as severe discomfort).

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The GAG score at baseline was 21±6. After the last PDT session, the GAG assessed in a blinded manner with the use of digital photographs decreased significantly to 6.5±5.7, which corresponded to a 70% reduction (mean difference, 14.9; 95% CI, 12.1-17.6; P =.0001). At the follow-up visit, the GAG score was 6.7±6.8. Overall, the 5% ALA thermosetting gel red-light PDT was very well tolerated, with a mean discomfort level score of 0.5±1.

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The investigators concluded that this study supports the efficacy of 5% ALA thermosetting gel red-light PDT for the treatment of inflammatory acne vulgaris. Clinical improvement was maintained in the medium term. Additional studies, including those with larger numbers of patients, are warranted to validate these findings.


Serini SM, Cannizzaro MV, Dattola A, et al. The efficacy and tolerability of 5-aminolevulinic acid 5% thermosetting gel photodynamic therapy (PDT) in the treatment of mild-to-moderate acne vulgaris. A two-center, prospective assessor-blinded, proof-of-concept study [published online May 22, 2018]. J Cosmet Dermatol. doi: 10.1111/jocd.12670