Photodynamic therapy with 80 mg/g methyl aminolaevulinate for severe facial acne vulgaris: a randomised vehicle-controlled study

Abstract

Background

Severe acne vulgaris has limited therapeutic options.

Objectives

To evaluate photodynamic therapy (PDT) using topical methyl aminolaevulinate (MAL, 80 mg/g) as the photosensitiser in severe facial acne

Methods

Double-blind, randomised, vehicle-controlled multicentre trial in 153 patients (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 MAL (n=100) or vehicle cream (n=53) 1.5 hours under occlusion, then illumination (635 nm red light, total dose 37 J/cm²). 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 pain (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 MAL 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 MAL PDT (44% vs. 26%, p=0.013). Pain was low and manageable by briefly pausing illumination. There was similar pain or erythema with successive treatments.

Conclusions

PDT using topical 80 mg/g MAL and red light may offer promise for severe acne vulgaris.

[ClinicalTrials. gov Identifier NCT01347879; registered May 3, 2011].

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