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Journal of the American Academy of Dermatology
Sous presse. Epreuves corrigées par l'auteur. Disponible en ligne depuis le mardi 28 janvier 2020
Doi : 10.1016/j.jaad.2019.09.010
accepted : 2 September 2019
A regimen to minimize pain during blue light photodynamic therapy of actinic keratoses: Bilaterally controlled, randomized trial of simultaneous versus conventional illumination
 

Urvashi Kaw, MD a, Muneeb Ilyas, DO a, Taylor Bullock, BS a, Lisa Rittwage, BSN, RN a, Margo Riha, BSN, RN a, Allison Vidimos, MD, MPh a, Bo Hu, PhD b, Christine B. Warren, MD, MS a, Edward V. Maytin, MD, PhD a,
a Department of Dermatology, Cleveland Clinic, Cleveland, Ohio 
b Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio 

Correspondence to: Edward V. Maytin, MD, PhD, Desk A60, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 4415.Desk A60, Cleveland Clinic9500 Euclid AveClevelandOH4415
Abstract
Background

Blue light photodynamic therapy (PDT) is effective for actinic keratosis, but many patients experience stinging pain during illumination.

Objective

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.

Methods

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.

Results

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.

Limitations

Although bilaterally controlled, the study was relatively small. Additional studies are recommended.

Conclusion

The modified PDT regimen is essentially painless, yet it provides treatment efficacy similar to a conventional regimen.

The full text of this article is available in PDF format.

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.



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