Pilot study utilizing short contact protocols for treatment of actinic keratoses (AK) with ALA gel-red light photodynamic therapy (PDT)

Main Article Content

Jessica Johnson
Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio, U.S.A.

Jackson Hanna
Department of Dermatology, Cleveland Clinic, Cleveland, OH, U.S.A.

Dr. Amy S. Nowacki
Quantitative Health Science, Cleveland Clinic, Cleveland, OH, U.S.A.

Sanjay Anand
Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio, U.S.A.; Department of Biomedical Engineering, Cleveland Clinic, Cleveland, OH, U.S.A.

Alan Shen
Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio, U.S.A.

Dr. Edward Maytin
Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio, U.S.A.; Department of Dermatology, Cleveland Clinic, Cleveland, OH, U.S.A.; Department of Biomedical Engineering, Cleveland Clinic, Cleveland, OH, U.S.A.

Keywords

Photodynamic therapy, PDT, Actinic keratosis, Actinic keratoses, ALA, Aminovelunic acid, Red light, protocols, Short incubation, Short contact protocols, PDT treatment protocols

Abstract

Background: Red light photodynamic therapy (PDT) is an effective option for actinic keratosis (AK) lesions. However, stinging pain during illumination limits utility.


 


Objective:  To compare three modified red-light PDT regimens (short incubation, whole-face application, no occlusion) and to determine whether these can reduce pain yet still provide significant AK lesion clearance.


 


Methods: Patients in this randomized clinical trial (n = 30) were randomized into one of three groups [incubation with 10% ALA gel, illumination with red-light]: Group A: 10 min, 20 min (75 J/cm2); Group B: 20 min, 10 min (37 J/cm2); Group C: 1 hour, 10 min (37 J/cm2). Two PDT treatments were administered 8 weeks apart. Lesions were counted at each visit, and pain was recorded on a scale from 0 – 10.


 


Results: Patients Groups A and B (shorter incubations) experienced significantly less pain during illumination than Group C.  After one treatment, the AK lesion reduction in Group A (59%) was statistically non-inferior to Group C (43%), with a noninferiority margin of ±15%. Final lesion counts after two PDT treatments showed a reduction from baseline by 82% in Group C, 76% in Group A, and 74% in Group B. Groups A and B did not meet the statistical non-inferiority endpoint relative to Group C after two treatments.


Limitations: Small sample size, which limited the ability to reach statistical significance after 2 PDT treatments.


 


Conclusion: Two short/modified red light PDT regimens were essentially painless, and all three provided AK lesion clearances comparable to conventional regimens.

References

1. Kaw U, Ilyas M, Bullock T, et al. A regimen to minimize pain during blue light photodynamic therapy of actinic keratoses: Bilaterally controlled, randomized trial of simultaneous versus conventional illumination. J Am Acad Dermatol. 2020;82(4):862-868. doi:10.1016/J.JAAD.2019.09.010

2. Pariser DM, Houlihan A, Ferdon MB, Berg JE. Randomized Vehicle-Controlled Study of Short Drug Incubation Aminolevulinic Acid Photodynamic Therapy for Actinic Keratoses of the Face or Scalp. Dermatologic Surg. 2016;42(3):296. doi:10.1097/DSS.0000000000000630

3. Gandy J, Labadie B, Farshidi DB, Zachary C. Photodynamic Therapy Effectively Treats Actinic Keratoses Without Pre-Illumination Incubation Time. J Drugs Dermatol. 2017;16(3):275. Accessed September 26, 2023. /pmc/articles/PMC6241219/

4. Martin GM, Martin G. In-office Painless Aminolevulinic Acid Photodynamic Therapy: A Proof of Concept Study and Clinical Experience in More Than 100 Patients. J Clin Aesthet Dermatol. 2016;9(2):19. Accessed September 26, 2023. /pmc/articles/PMC4771386/

5. Anvery N, Christensen RE, Dirr MA, et al. Comparative effectiveness of 5-aminolevulinic acid photodynamic therapy with no incubation versus one-hour incubation for the treatment of actinic keratosis: A randomized controlled trial. J Am Acad Dermatol. 2023;89(2):401-403. doi:10.1016/J.JAAD.2023.03.056

6. Li J, Zhang Y, Zhang G, et al. Modified painless photodynamic therapy for facial multiple actinic keratosis in China: A prospective split-face control study. Lasers Surg Med. 2023;55(10). doi:10.1002/LSM.23728

7. Mordon S, Vignion-Dewalle AS, Abi-Rached H, et al. The conventional protocol vs. a protocol including illumination with a fabric-based biophotonic device (the Phosistos protocol) in photodynamic therapy for actinic keratosis: a randomized, controlled, noninferiority clinical study. Br J Dermatol. 2020;182(1):76-84. doi:10.1111/BJD.18048

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Published
Nov 18, 2024
DOI https://doi.org/10.25251/skin.8.supp.486

Article Details

How to Cite
[1]
Johnson, J., Hanna, J., Nowacki, A., Anand, S., Shen, A. and Maytin, E. 2024. Pilot study utilizing short contact protocols for treatment of actinic keratoses (AK) with ALA gel-red light photodynamic therapy (PDT). SKIN The Journal of Cutaneous Medicine. 8, 6 (Nov. 2024), s486. DOI:https://doi.org/10.25251/skin.8.supp.486.
Issue
Vol. 8 No. 6 (2024): November 2024 Issue
Section
Skin Cancer
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