Blue light photodynamic therapy (PDT) is effective for actinic keratosis, but many patients experience stinging pain during illumination.
To compare a conventional regimen (1 hour of 5-aminolevulinic acid [ALA] preincubation, followed by blue light) versus a new modified regimen in which blue light is started immediately after ALA application.
A clinical trial with a bilaterally controlled, intrapatient study design was conducted with 23 patients. Topical 20% ALA was applied to the entire face and/or scalp. On 1 side of the body, blue light was started immediately and continued for either 30, 45, or 60 minutes (simultaneous PDT). On the contralateral side, the blue light began 1 hour after ALA application and lasted 1000 seconds (conventional PDT). Pain was evaluated on a scale from 0 to 10. Actinic keratosis lesion counts were determined by clinical examination and photography.
All patients experienced significantly less pain during simultaneous illumination than during the conventional regimen. At 3 months after treatment, lesion clearance was nearly identical on the 2 sides, as determined by statistical testing of noninferiority ± 15% margin.
Although bilaterally controlled, the study was relatively small. Additional studies are recommended.
The modified PDT regimen is essentially painless, yet it provides treatment efficacy similar to a conventional regimen.Le texte complet de cet article est disponible en PDF.
Key words : clinical research, oncology, phototherapy, skin cancer, therapeutics
Abbreviations used : AK, ALA, PDT, PpIX
| Funding sources: Supported by the Cleveland Clinic Research Protocol Committee fund (to Dr Maytin), Sun/DUSA Pharmaceuticals, investigator-initiated grant (to Dr Maytin), and grant number P01CA084203 (Drs Hasan and Maytin) from the National Cancer Institute of the National Institutes of Health, USA.
| Conflicts of interest: None disclosed.
| IRB approval status: Reviewed and approved by Cleveland Clinic institutional review board (approval no. 14-374).
| Reprints not available from the authors.