Evidence map›Paper›PMID 40581198›Full record

Trial reportPhotodiagnosis and photodynamic therapy2025

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

Jessica S Johnson, Jackson Hanna, Amy S Nowacki, Sanjay Anand, Alan S Shen, Edward V Maytin

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Photodiagnosis and photodynamic therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06027619 (Short Contact Protocols to Reduce Pain During Treatment of Actinic Keratoses With 10% ALA Gel Red-light Photodynamic Therapy), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06027619 phase2completednot on this map

Short Contact Protocols to Reduce Pain During Treatment of Actinic Keratoses With 10% ALA Gel Red-light Photodynamic Therapy (PDT)

TypeinterventionalSponsorCase Comprehensive Cancer CenterRan2023 to 2024Enrolled30ConditionsActinic KeratosisArmsTopical aminolevulinate (10% ALA gel), Red light illumination
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Jessica S JohnsonCleveland Clinic Lerner College of Medicine of Case Western Reserve University School of Medicine, Cleveland, OH, USA.
Jackson HannaDepartment of Dermatology, OH, USA.
Amy S NowackiDepartment of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH, USA.
Sanjay AnandDepartment of Biomedical Engineering, OH, USA.
Alan S ShenCleveland Clinic Lerner College of Medicine of Case Western Reserve University School of Medicine, Cleveland, OH, USA.
Edward V MaytinCleveland Clinic Lerner College of Medicine of Case Western Reserve University School of Medicine, Cleveland, OH, USA; Department of Dermatology, OH, USA; Department of Biomedical Engineering, OH, USA. Electronic address: maytine@ccf.org.

Funding

Small Molecule Enhancers of Photodynamic Therapy for Skin CancerP01CA084203 · NCI · MASSACHUSETTS GENERAL HOSPITAL · PI Bryan Quilty Spring · 2001 to 2026
$27.9M
NCI NIH HHS P01 CA084203
6 · The paper itself

Abstract

backgroundTraditional red light photodynamic therapy for actinic keratoses (AK) causes significant pain during illumination.

objectiveTo evaluate new short-incubation red light PDT regimens for their pain and efficacy characteristics.

methodsPatients (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/cm

resultsAt 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 of the new short incubation protocols (done without occlusion) were not compared directly with the long (3-hour) FDA-approved protocol that is done with occlusion.

conclusionShort-contact red light PDT regimens are essentially painless and appear to provide very good AK lesion clearance. CLINICAL

trial registrationNCT06027619 (date of trial registration: 31 August 2023).

Indexed as

Aminolevulinic AcidKeratosis, ActinicPhotochemotherapyPhotosensitizing AgentsAgedAged, 80 and overFemaleGelsHumansMaleMiddle AgedPainPilot ProjectsRed LightAminolevulinic AcidGelsPhotosensitizing AgentsActinic keratosesAminolevulinic acidPainPhotodynamic therapyRed light

Identifiers

PMID40581198
PMCPMC12335217

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.