Painless PDT using 10% aminolevulinate gel and red light - A pilot clinical trial of short-contact protocols to reduce discomfort during illumination

Sep 23, 2026

Uploaded by Grenda

Background: Traditional red light photodynamic therapy (PDT) for actinic keratoses (AK) causes significant pain during illumination. Objective: To evaluate short-incubation red light PDT regimens for pain and efficacy characteristics. Methods: Patients (n=30) with facial AK received 10% ALA gel without occlusion and 635 nm red light, randomized to three incubation/illumination combinations, then underwent two PDT treatments spaced 8 weeks apart. Pain and lesion counts were tracked during visits, with final counts at 3–6 months.

LanguageEnglish

CategoryHealthcare

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Pages19

Reading Time48 min

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Abstract

Background and Objective

Methods

Results

Limitations

Conclusion

Introduction

Author Manuscript Author Manuscript Author Manuscript Author Manuscript | | HHS Public Access
Author manuscript
Photodiagnosis Photodyn Ther. Author manuscript; available in PMC 2025 August 09. | | --- | --- | Published in final edited form as: Photodiagnosis Photodyn Ther. 2025 August ; 54: 104698. doi:10.1016/j.pdpdt.2025.104698 . Painless PDT using 10% aminolevulinate gel and red light: A pilot clinical trial of short-contact protocols to reduce discomfort during illumination Jessica S. Johnsona, Jackson Hannab, Amy S. Nowackid, Sanjay Anandc, Alan S. Shena, Edward V. Maytina,b,c,* aCleveland Clinic Lerner College of Medicine of Case Western Reserve University School of Medicine, Cleveland, OH, USA b Department of Dermatology, OH, USAc Department of Biomedical Engineering, OH, USA d Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH, USA Abstract Background: Traditional red light photodynamic therapy for actinic keratoses (AK) causes significant pain during illumination. Objective: To evaluate new short-incubation red light PDT regimens for their pain and efficacy characteristics. Methods: Patients (n = 30) with facial AK were treated with 10 % ALA gel (no occlusion) and red light (635 nm), after randomization as follows [incubation time, illumination time (fluence)]: Group A [10 min, 20 min (74 J/cm2)]; Group B [20 min, 10 min (37 J/cm2)]; Group C [1 hour, 10 min (37 J/cm2)] . Pain and AK lesion counts were recorded during two PDT treatments spaced 8 weeks apart. Final lesion counts were at 3–6 months. This is an open access article under the CC BY license ([http://creativecommons.org/licenses/by/4.0/](http://creativecommons.org/licenses/by/4.0/)). *Corresponding author at: Department of Dermatology, Crile Building, Desk A60, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195, [USA. maytine@ccf.org](USA. maytine@ccf.org) (E.V. Maytin). [Clinicaltrials.gov](Clinicaltrials.gov) NCT06027619 Patient consent on file Consent for the publication of recognizable patient photographs or other identifiable material was obtained by the authors and included at the time of article submission to the journal stating that all patients gave consent with the understanding that this information may be publicly available. Reprint requests Edward Maytin CRediT authorship contribution statement Jessica S. Johnson: Writing – review & editing, Writing – original draft, Investigation, Formal analysis, Data curation. Jackson Hanna: Project administration, Investigation. Amy S. Nowacki: Writing – original draft, Formal analysis, Conceptualization. Sanjay Anand: Validation, Formal analysis. Alan S. Shen: Validation, Formal analysis. Edward V. Maytin: Writing – review & editing, Investigation, Conceptualization, Funding acquisition. Declaration of competing interest The authors declare no potential conflicts of interest. Author Manuscript Author Manuscript Author Manuscript Author Manuscript Johnson et al. Page 2 Results: At both treatment visits, Group A and B patients experienced negligible pain that was statistically less than that of Group C patients. AK clearance after two PDT treatments was robust and similar amongst the three treatment groups (76 % for Group A, 74 % for Group B, and 82 % for Group C). Using a non-inferiority margin of 15 %, lesion reduction in Group A was statistically non-inferior to Group C after one PDT treatment. Limitations: Efficacy rates ofthe new short incubation protocols (done without occlusion) were not compared directly with the long (3-hour) FDA-approved protocol that is done with occlusion. Conclusion: Short-contact red light PDT regimens are essentially painless and appear to provide very good AK lesion clearance. Clinical trial registration: NCT06027619 (date of trial registration: 31 August 2023) . Keywords Photodynamic therapy; Aminolevulinic acid; Actinic keratoses; Red light; Pain 1. Introduction Squa

FAQs

What problem does this pilot trial address in actinic keratosis treatment?

Traditional red light PDT for actinic keratoses causes significant pain during illumination. This study tests whether shorter-contact red light PDT protocols can reduce discomfort while maintaining efficacy.

How were patients treated in the three randomized groups?

Patients with facial AK received 10% ALA gel without occlusion and 635 nm red light, randomized to different incubation and illumination time combinations: Group A (10 min/20 min), Group B (20 min/10 min), and Group C (1 hour/10 min).

What did the trial find about pain and lesion clearance?

At both treatment visits, Groups A and B experienced negligible pain, significantly less than Group C. AK clearance after two treatments was robust and similar across groups, with lesion reduction in Group A non-inferior to Group C after one treatment.

Sep 23, 2026

Uploaded by Grenda