A prospective split-face double-blind randomized placebo-controlled trial to assess the efficacy of methyl aminolevulinate + red-light in patients with facial photodamage

J Eur Acad Dermatol Venereol. 2011 Jan;25(1):49-58. doi: 10.1111/j.1468-3083.2010.03687.x.


Background: To date, there is no gold standard therapy for skin photoageing. In the last decade, laser technologies have offered great promise among skin-rejuvenation therapies; however, both non-ablative and ablative fractional resurfacing modalities have their own benefits and drawbacks. More recently, open-label studies and few controlled trials have suggested that photodynamic therapy may have therapeutic potential in photodamage.

Objective: To assess the efficacy of methyl aminolevulinate + red-light on facial photodamage in a double-blind split-face randomized placebo-controlled trial.

Methods: Subjects had initially two split-face treatments 2-3 weeks apart in which half of the face was treated with MAL + red-light compared with placebo + red-light. Primary outcome was the assessment of global photodamage 1 month after session 2. Secondary outcomes included the assessment of fine lines, mottled pigmentation, tactile roughness, sallowness, erythema and telangiectasia 1 month after session 2, according to severity scores rated as failure, improvement or success.

Results: Based on the intention-to-treat analysis, a total of 48 patients (96 split-faces) were included. Facial global photodamage success or improvement had occurred in 94 split-faces and in no split-faces receiving placebo (RR: 0.02; 95% confidence interval, 0.0-0.14; P = 0.0000). One patient had an adverse event that led to the discontinuation of the therapy after session 1.

Conclusions: Methyl aminolevulinate + red-light demonstrated significantly superior efficacy in global facial photodamage compared with placebo. This therapy was also useful for all other specific secondary outcomes, except for telangiectasia. Overall, MAL + red-light sessions were well tolerated and resulted in high/total patient satisfaction in the majority of subjects (80.4%).

Publication types

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

MeSH terms

  • Adult
  • Aminolevulinic Acid / adverse effects
  • Aminolevulinic Acid / analogs & derivatives*
  • Aminolevulinic Acid / pharmacology
  • Aminolevulinic Acid / therapeutic use
  • Double-Blind Method
  • Face*
  • Female
  • Humans
  • Middle Aged
  • Phototherapy* / adverse effects
  • Placebos
  • Prospective Studies
  • Skin Aging / drug effects*
  • Skin Aging / radiation effects


  • Placebos
  • methyl 5-aminolevulinate
  • Aminolevulinic Acid