Pariser et al

Title: Photodynamic therapy with topical methyl aminolevulinate for actinic keratosis: results of a prospective randomized multicenter trial.

Author: Pariser DM, Lowe NJ, Stewart DM, Jarratt MT, Lucky AW, Pariser RJ, et al.

Journal Reference: J Am Acad Dermatol 2003;48:227-32 (by clicking on this link you will be leaving this site - Galderma is not responsible for the content)

Objective: to evaluate the efficacy, patient satisfaction and cosmetic outcome of photodynamic therapy (PDT) using methyl aminolevulinate cream (MAL; Metvix®) compared with a placebo cream in the treatment of actinic keratosis (AK) lesions.

Design: this North American based multi-centre, double-blind, controlled trial randomised 80 adult patients (70 males), with previously untreated mild- to-moderate, non-pigmented actinic keratosis lesions, into two treatment groups. The first group (42 patients) were treated with MAL-PDT (160 mg/g) and the second (38 patients) with placebo-PDT. Hyperkeratotic crusts were removed from the lesions by gentle curettage prior to treatment. Treatment was repeated one week later. Follow-up assessment was at 3-months after last treatment.

Key Results:

  • The complete response rate at three months after treatment with MAL-PDT was 82%, significantly higher than with placebo-PDT 21% (P=0.001).
  • Lesion response rate was significantly higher in the actively treated group, 89% compared with 38% in the placebo group.
  • Cosmetic outcome was considered excellent or very good by 97% of investigators in patients with complete response after MAL-PDT.
  • Overall patient satisfaction with MAL-PDT compared with previous non-photodynamic treatments was very high (73%).
  • As expected, local adverse reactions were more frequent in the active treatment group and were in general mild to moderate in intensity.

Conclusion: this study confirmed that photodynamic therapy with methyl aminolevulinate cream (MAL, Metvix®) was effective and well-tolerated, as well as being highly acceptable cosmetically. These attributes, combined with the convenient and non-invasive nature of the therapy, is likely to be responsible for the high levels of satisfaction reported with the treatment, making MAL-PDT an attractive treatment option for actinic keratosis.