Phase 2 Completed N=30 Randomized Treatment

Short Contact Protocols to Reduce Pain During 10% ALA Gel Red-light Photodynamic Therapy of Actinic Keratoses

Source: ClinicalTrials.gov NCT06027619 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2025

Primary outcomePrimary: Treatment Efficacy Based on Participant AK Lesion Clearance — 59; 34; 43; 76 percentage of AK lesions

Summary

The goal of this clinical trial is to see if shorter Photodynamic Therapy (PDT) treatment times will still be effective at treating actinic keratoses (AK) while reducing or eliminating the pain that patients sometimes experience during conventional PDT treatment. The main questions it aims to answer are: * Will the application of the nanoemulsion (10% ALA gel), in the absence of occlusion, still achieve significant inflammation and lesion clearance? * Will shortened incubation times of Ameluz still achieve significant inflammation and lesion clearance? * Will the new test regimens achieve reduced pain during illumination? * Will the new test regimens be safe? Participants will be randomly assigned to one of three treatment regimens, which will determine the length of time that the topical medication will incubate on the face before red light exposure in PDT treatments. The incubation period will be either 10 minutes, 20 minutes, or 60 minutes.

Outcome Measures

Outcome	Result	p-value
PRIMARY Treatment Efficacy Based on Participant AK Lesion Clearance	59; 34; 43; 76; 74; 82	—
PRIMARY Differences in Pain Level Reported Throughout Exposure to Red Light	0.70; 0.10; 4.7; 0.20; 0.30; 2.22	—
SECONDARY Patient Satisfaction Survey as Measured by Treatment Outcome Score	80; 60; 89; 10; 30; 11	—
SECONDARY Patient Satisfaction Survey as Measured by Cosmetic Outcome Score	70; 50; 89; 20; 40; 0	—
SECONDARY Number of Participant Reported Adverse Events and Side Effects	0; 0; 2; 9; 10; 9	—

Eligibility Criteria

Inclusion Criteria

Minimum of 10 actinic keratoses lesions on the face.
Female subjects must not become pregnant during the study
Subjects must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria

Pregnant or nursing.
Using any topical treatment on their AKs; must stop at least one month prior.
Currently undergoing treatment for other cancers with medical or radiation therapy.
Patients with a known hypersensitivity to 5-aminolevulinic acid or any component of the study material.
Patients with history of a photosensitivity disease, such as porphyria cutanea tarda.

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Data sourced from ClinicalTrials.gov (NCT06027619). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.