A randomized multicenter study to compare two treatment regimens of topical methyl aminolevulinate (Metvix)-PDT in actinic keratosis of the face and scalp

Acta Derm Venereol. 2005;85(5):424-8. doi: 10.1080/00015550510032887.


Photodynamic therapy (PDT) with topical methyl aminolevulinate (MAL) administered in two treatment sessions separated by 1 week is an effective treatment for actinic keratoses. This open prospective study compared the efficacy and safety of MAL-PDT given as a single treatment with two treatments of MAL-PDT 1 week apart. Two hundred and eleven patients with 413 thin to moderately thick actinic keratoses were randomized to either a single treatment with PDT using topical MAL (regimen I; n=105) or two treatments 1 week apart (regimen II; n=106). Each treatment involved surface debridement, application of Metvix cream (160 mg/g) for 3 h, followed by illumination with red light using a light-emitting diode system (peak wavelength 634+/-3 nm, light dose 37 J/cm2). Thirty-seven lesions (19%) with a non-complete response 3 months after a single treatment were re-treated. All patients were followed up 3 months after the last treatment. A total of 400 lesions, 198 initially treated once and 202 treated twice, were evaluable. Complete response rate for thin lesions after a single treatment was 93% (95% CI=87-97%), which was similar to 89% (82-96%) after repeated treatment. Response rates were lower after single treatment of thicker lesions (70% (60-78%) vs 84% (77-91%)), but improved after repeated treatment (88% (82-94%)). The conclusion of this study is that single treatment with topical MAL-PDT is effective for thin actinic keratosis lesions; however, repeated treatment is recommended for thicker or non-responding lesions.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Topical
  • Aged
  • Aminolevulinic Acid / administration & dosage
  • Aminolevulinic Acid / adverse effects
  • Aminolevulinic Acid / analogs & derivatives*
  • Facial Dermatoses / drug therapy*
  • Facial Dermatoses / etiology
  • Female
  • Humans
  • Keratosis / drug therapy*
  • Keratosis / etiology
  • Male
  • Photochemotherapy*
  • Photosensitizing Agents / administration & dosage*
  • Photosensitizing Agents / adverse effects
  • Scalp Dermatoses / drug therapy*
  • Scalp Dermatoses / etiology
  • Ultraviolet Rays / adverse effects*


  • Photosensitizing Agents
  • methyl 5-aminolevulinate
  • Aminolevulinic Acid