A randomised, double-blind, placebo-controlled trial of photodynamic therapy using 5-aminolaevulinic acid for the treatment of cervical intraepithelial neoplasia

Int J Cancer. 2003 Mar 1;103(6):829-32. doi: 10.1002/ijc.10888.

Abstract

Photodynamic therapy (PDT) using topical 5-aminolaevulinic acid (ALA) has been used to treat histologically confirmed cervical intraepithelial neoplasia (CIN-I and -I/II) in a randomised, double-blind, placebo-controlled protocol. Fluorescence microscopy revealed that topical application of 3% ALA in Intrasite Gel to the cervix for 3 hr resulted in the accumulation of protoporphyrin IX in the cervical epithelium. Treatment of CIN with ALA-PDT was well tolerated, with only 3/12 patients in the PDT arm (0/13 in the placebo arm) reporting any discomfort during illumination. Histologic examination of the treated tissue following loop excision 3 months post-PDT indicated that 33% of patients had no evidence of CIN, 42% had no change in the grade of their disease, whilst 25% exhibited an apparent progression of disease. In the control group, the respective figures were 31%, 38% and 31%. There was no significant difference in response between the groups receiving ALA-PDT and those receiving placebo treatment.

Publication types

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

MeSH terms

  • Administration, Topical
  • Adult
  • Aminolevulinic Acid / therapeutic use*
  • Cervix Uteri / drug effects
  • Colposcopy
  • Double-Blind Method
  • Female
  • Humans
  • Image Processing, Computer-Assisted
  • Microscopy, Fluorescence
  • Photochemotherapy*
  • Photosensitizing Agents / therapeutic use*
  • Protoporphyrins / metabolism
  • Uterine Cervical Dysplasia / drug therapy*
  • Uterine Cervical Neoplasms / drug therapy*

Substances

  • Photosensitizing Agents
  • Protoporphyrins
  • Aminolevulinic Acid
  • protoporphyrin IX