Photodynamic therapy using topical methyl aminolevulinate vs surgery for nodular basal cell carcinoma: results of a multicenter randomized prospective trial

Arch Dermatol. 2004 Jan;140(1):17-23. doi: 10.1001/archderm.140.1.17.


Background: Photodynamic therapy (PDT) is increasingly used as a noninvasive treatment for nodular basal cell carcinoma (BCC), without a sound evidence base.

Objective: To compare topical PDT, with the use of the sensitizer methyl aminolevulinate, and standard excision surgery in nodular BCC.

Design: Prospective, randomized study.

Setting: University dermatology departments.

Patients: A total of 101 adults with previously untreated nodular BCC.

Interventions: Patients received methyl aminolevulinate PDT (n = 52) or surgery (n = 49). The PDT was given twice, 7 days apart, with methyl aminolevulinate cream (160 mg/g) and 75 J/cm(2) red light (570-670 nm). Thirteen patients with a noncomplete response to PDT at 3 months (24% lesions) were retreated.

Outcome measures: Primary end point was clinically assessed lesion clearance at 3 months after treatment. Secondary end points were sustained response rate at 12 months and cosmetic outcome at 3 and 12 months. Cosmesis and lesion recurrence were further assessed at 24 months.

Results: Data from 97 patients (105 lesions) were included in the 3-month per-protocol analysis. Complete response rates did not differ significantly between groups (51/52 [98%] lesions with surgery vs 48/53 [91%] lesions with methyl aminolevulinate PDT; difference [95% confidence interval], 4.8% (-3.4% to 13.0%]; P =.25). At 12 months, tumor-free rates were 50 (96%) of 52 lesions with surgery vs 44 (83%) of 53 with methyl aminolevulinate PDT (P =.15). More patients treated with methyl aminolevulinate PDT than surgery had an excellent or good cosmetic outcome at all time points (significant at 12 and 24 months on patient assessment, P<.05, and at 3, 12, and 24 months on investigator evaluation, P<.001). At 24 months, 5 lesions that had initially cleared with methyl aminolevulinate PDT had recurred, compared with 1 after surgery.

Conclusions: Methyl aminolevulinate PDT is an effective treatment for nodular BCC, and while there is a trend for higher recurrence with this modality, it conveys the advantage over surgery of better cosmesis.

Publication types

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

MeSH terms

  • Administration, Topical
  • Adult
  • Aged
  • Aged, 80 and over
  • Aminolevulinic Acid / administration & dosage*
  • Aminolevulinic Acid / adverse effects
  • Aminolevulinic Acid / analogs & derivatives*
  • Carcinoma, Basal Cell / drug therapy*
  • Carcinoma, Basal Cell / surgery*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Ointments
  • Photochemotherapy* / adverse effects
  • Photosensitizing Agents / administration & dosage*
  • Photosensitizing Agents / adverse effects
  • Prospective Studies
  • Skin Neoplasms / drug therapy*
  • Skin Neoplasms / surgery*


  • Ointments
  • Photosensitizing Agents
  • methyl 5-aminolevulinate
  • Aminolevulinic Acid