Freeman et al

Title:  A comparison of photodynamic therapy using topical methyl aminolevulinate (Metvix®) with single cycle cryotherapy in patients with actinic keratosis: a prospective, randomized study.

Author: Freeman M, Vinciullo C, Francis D, Spelman L, Nguyen R, Fergin P, et al.

Journal Reference: J Dermatol Treat 2003;14:99-106 (by clicking on this link you will be leaving this site - Galderma is not responsible for the content)

Objective: To compare the efficacy and tolerability of photodynamic therapy (PDT) using methyl aminolevulinate (MAL; Metvix®) with placebo or a single cycle of cryotherapy in the treatment of actinic keratosis (AK).

Design: Two hundred adult patients with mild-to-moderate, non-pigmented actinic keratosis lesions were treated in this randomised, parallel group, multicentre, reference- and placebo-controlled Australian study. The study was open with regard to PDT vs. cryotherapy, but double-blind for MAL vs. placebo PDT.

Overall, 88 patients received MAL (160 mg/g) PDT, 89 were treated with cryotherapy and 23 received placebo PDT. Lesions were prepared by gentle curettage before PDT.  PDT was repeated seven days after the first treatment. Patients in the cryotherapy group received a single timed freeze-thaw cycle of treatment in accordance with each centre's normal clinical practice. Efficacy responses were evaluated at 3-months.

Key Results:

  • The lesion response rate at three months was 91% after PDT with Metvix®, significantly higher than with placebo PDT (30%; P<0.001) or cryotherapy (68%; P<0.001).
  • Cosmetic outcome was considered excellent in the active photodynamic treatment group by 83% and 76% of investigators and patients, respectively, compared with 51% and 56% of investigators and patients, respectively, in the cryotherapy group.
  • Overall patient satisfaction with Metvix® PDT was high, with 61% of patients rating it as better compared with previous treatments.
  • The most common adverse events reported were local and expected. Most reactions were considered mild or moderate in intensity and were of short duration.

Conclusion: Photodynamic therapy with methyl aminolevulinate (MAL; Metvix®) is a superior treatment to both cryotherapy and PDT with placebo in the treatment of thin actinic keratosis facial lesions. This treatment option results in high patient satisfaction by combining clinical efficacy with excellent cosmetic outcomes.