title: Fractional laser-mediated photodynamic therapy of high-risk basal cell carcinomas--a randomized clinical trial.
abstract: BACKGROUND
  Photodynamic therapy (PDT) is approved for selected nodular basal cell carcinomas (nBCC) but efficacy is reduced for large and thick tumours. Ablative fractional lasers (AFXL) facilitate uptake of methyl aminolaevulinate (MAL) and may thus improve PDT outcome.
  
  
  OBJECTIVE
  To evaluate efficacy and safety of AFXL-mediated PDT (AFXL-PDT) compared with conventional PDT of high-risk nBCC.
  
  
  METHODS
  Patients with histologically verified facial nBCC (n = 32) defined as high-risk tumours were included; diameter > 15 mm, tumours located in high-risk zones, or on severely sun-damaged skin. Tumours were debulked and patients randomized to either AFXL-PDT (n = 16) or PDT (n = 16). Fractional CO2 laser treatment was applied at 5% density and 1000 μm (80 mJ) ablation depth. MAL was applied under occlusion for 3 h and illuminated with a 633-nm light-emitting diode source, 37 J cm(-2) . Clinical assessments were performed at 3, 6, 9 and 12 months and biopsies were taken at 12 months.
  
  
  RESULTS
  Clinical cure rates at 3 months were 100% (16 of 16 AFXL-PDT) and 88% (14 of 16 PDT, P = 0·484). Recurrences tended to occur later and in lower numbers after AFXL-PDT at 6, 9 and 12 months (6%, 19%, 19%) than PDT (25%, 38%, 44%) (P = 0·114). Histology at 12 months documented equal tumour clearance after AFXL-PDT (63%, 10 of 16) and PDT (56%, 9 of 16). Cosmetic outcomes were highly satisfactory after both treatments (P > 0·090).
  
  
  CONCLUSIONS
  Long-term efficacy was similar after PDT and AFXL-PDT with a trend for a favourable short-term cure rate after AFXL-PDT. AFXL-PDT needs further refinement for nBCC and at present is not recommended over PDT.
authors.affiliation: Department of Dermatology, D-92, Bispebjerg Hospital, University of Copenhagen, Bispebjerg Bakke 23, DK-2400, Copenhagen NV, Denmark; Wellman Center for Photomedicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, U.S.A.
authors.forename: C S
authors.initials: CS
authors.lastname: Haak
authors.forename: K
authors.initials: K
authors.lastname: Togsverd-Bo
authors.forename: D
authors.initials: D
authors.lastname: Thaysen-Petersen
authors.forename: H C
authors.initials: HC
authors.lastname: Wulf
authors.forename: U
authors.initials: U
authors.lastname: Paasch
authors.forename: R R
authors.initials: RR
authors.lastname: Anderson
authors.forename: M
authors.initials: M
authors.lastname: Haedersdal
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000622:Aminolevulinic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use; D002280:Basal Cell Carcinoma / Q000188:drug therapy*; D003131:Combined Modality Therapy; D005153:Facial Neoplasms / Q000188:drug therapy*; D005260:Female; D005453:Fluorescence; D006801:Humans; D053685:Laser Therapy / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D054020:Lasers, Gas / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000209:etiology; D010778:Photochemotherapy / Q000009:adverse effects / Q000379:methods*; D017319:Photosensitizing Agents / Q000627:therapeutic use; D012307:Risk Factors; D012878:Skin Neoplasms / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D017319:Photosensitizing Agents; C475457:methyl 5-aminolevulinate; D000622:Aminolevulinic Acid