Trial Outcomes & Findings for Short Contact Protocols to Reduce Pain During 10% ALA Gel Red-light Photodynamic Therapy of Actinic Keratoses (NCT NCT06027619)

Last Updated: 2025-10-23

Results Overview

To test the hypothesis that a short-contact PDT protocol with Ameluz and red light will produce lesion clearance outcomes that are statistically non-inferior to the traditional, painful protocol. This will be measured by Clinical Efficacy, which will be based on the AK lesion counts and lesion clearance rate after two treatments.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

Lesion clearance at Visit 3 (month 2) and at Visit 4 (month 6)

Results posted on

2025-10-23

Participant Flow

A total of 10 subjects are enrolled for each of the study arms A, B, and C.

Participant milestones

Participant milestones
Measure	Regimen A Apply topical aminolevulinic acid gel and incubate for 10 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2	Regimen B Apply topical aminolevulinic acid gel and incubate for 20 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2	Regimen C Apply topical aminolevulinic acid gel and incubate for 60 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2
Overall Study STARTED	10	10	10
Overall Study COMPLETED	10	10	9
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Regimen A Apply topical aminolevulinic acid gel and incubate for 10 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2	Regimen B Apply topical aminolevulinic acid gel and incubate for 20 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2	Regimen C Apply topical aminolevulinic acid gel and incubate for 60 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2
Overall Study Adverse Event	0	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Lesion clearance at Visit 3 (month 2) and at Visit 4 (month 6)

Outcome measures

Outcome measures
Measure	Regimen A n=10 Lesions Apply topical aminolevulinic acid gel and incubate for 10 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2	Regimen B n=10 Lesions Apply topical aminolevulinic acid gel and incubate for 20 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2	Regimen C n=9 Lesions Apply topical aminolevulinic acid gel and incubate for 60 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2
Treatment Efficacy Based on Participant AK Lesion Clearance Lesion clearance rate at Visit 3	59 percentage of AK lesions	34 percentage of AK lesions	43 percentage of AK lesions
Treatment Efficacy Based on Participant AK Lesion Clearance Lesion clearance rate at Visit 4	76 percentage of AK lesions	74 percentage of AK lesions	82 percentage of AK lesions

PRIMARY outcome

Timeframe: Pain measured during illumination with red light (during a 10 min period) at Visit 1 (Day 3) and at Visit 3 (Month 2)

Pain will be reported by the participants during illumination will be measured on a subjective 11-point visual-analog scale (VAS scale 0= no pain, 10 = intolerable pain)

Outcome measures

Outcome measures
Measure	Regimen A n=10 Participants Apply topical aminolevulinic acid gel and incubate for 10 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2	Regimen B n=10 Participants Apply topical aminolevulinic acid gel and incubate for 20 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2	Regimen C n=9 Participants Apply topical aminolevulinic acid gel and incubate for 60 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2
Differences in Pain Level Reported Throughout Exposure to Red Light Pain at visit 1	0.70 score on a scale Standard Error 0.32	0.10 score on a scale Standard Error 0.11	4.7 score on a scale Standard Error 0.65
Differences in Pain Level Reported Throughout Exposure to Red Light Pain at visit 3	0.20 score on a scale Standard Error 0.21	0.30 score on a scale Standard Error 0.16	2.22 score on a scale Standard Error 0.68

SECONDARY outcome

Timeframe: 6 months

Treatment score on a scale of 0 to 5, where 0 indicates extremely dissatisfied and 5 indicates extremely satisfied.

Outcome measures

Outcome measures
Measure	Regimen A n=10 Participants Apply topical aminolevulinic acid gel and incubate for 10 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2	Regimen B n=10 Participants Apply topical aminolevulinic acid gel and incubate for 20 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2	Regimen C n=9 Participants Apply topical aminolevulinic acid gel and incubate for 60 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2
Patient Satisfaction Survey as Measured by Treatment Outcome Score Percentages of patients giving a score of 3	10 percentage of patients	10 percentage of patients	0 percentage of patients
Patient Satisfaction Survey as Measured by Treatment Outcome Score Percentages of patients giving a score of 5	80 percentage of patients	60 percentage of patients	89 percentage of patients
Patient Satisfaction Survey as Measured by Treatment Outcome Score Percentages of patients giving a score of 4	10 percentage of patients	30 percentage of patients	11 percentage of patients
Patient Satisfaction Survey as Measured by Treatment Outcome Score Percentages of patients giving a score of 2	0 percentage of patients	0 percentage of patients	0 percentage of patients
Patient Satisfaction Survey as Measured by Treatment Outcome Score Percentages of patients giving a score of 1	0 percentage of patients	0 percentage of patients	0 percentage of patients

SECONDARY outcome

Timeframe: At month 6

Cosmetic score on a scale of 0 to 5, where 0 indicates extremely dissatisfied and 5 indicates extremely satisfied.

Outcome measures

Outcome measures
Measure	Regimen A n=10 Participants Apply topical aminolevulinic acid gel and incubate for 10 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2	Regimen B n=10 Participants Apply topical aminolevulinic acid gel and incubate for 20 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2	Regimen C n=9 Participants Apply topical aminolevulinic acid gel and incubate for 60 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2
Patient Satisfaction Survey as Measured by Cosmetic Outcome Score Percentage of participants giving a score of 4	20 percentage of patients	40 percentage of patients	0 percentage of patients
Patient Satisfaction Survey as Measured by Cosmetic Outcome Score Percentage of participants giving a score of 3	10 percentage of patients	10 percentage of patients	11 percentage of patients
Patient Satisfaction Survey as Measured by Cosmetic Outcome Score Percentage of participants giving a score of 5	70 percentage of patients	50 percentage of patients	89 percentage of patients
Patient Satisfaction Survey as Measured by Cosmetic Outcome Score Percentage of participants giving a score of 2	0 percentage of patients	0 percentage of patients	0 percentage of patients
Patient Satisfaction Survey as Measured by Cosmetic Outcome Score Percentage of participants giving a score of 1	0 percentage of patients	0 percentage of patients	0 percentage of patients

SECONDARY outcome

Timeframe: Up to 6 days (Day 6) after Visit 1

Overall AE Profile and Safety of treatment will be measured using an Adverse Events- Patients' side effects log and Investigator assessment.

Outcome measures

Outcome measures
Measure	Regimen A n=9 Participants Apply topical aminolevulinic acid gel and incubate for 10 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2	Regimen B n=10 Participants Apply topical aminolevulinic acid gel and incubate for 20 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2	Regimen C n=9 Participants Apply topical aminolevulinic acid gel and incubate for 60 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2
Number of Participant Reported Adverse Events and Side Effects Adverse events	0 Number of events	0 Number of events	2 Number of events
Number of Participant Reported Adverse Events and Side Effects Side effects	9 Number of events	10 Number of events	9 Number of events

Adverse Events

Regimen A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Regimen B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Regimen C

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Regimen A n=10 participants at risk Apply topical aminolevulinic acid gel and incubate for 10 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2	Regimen B n=10 participants at risk Apply topical aminolevulinic acid gel and incubate for 20 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2	Regimen C n=10 participants at risk Apply topical aminolevulinic acid gel and incubate for 60 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2
General disorders Chills	0.00% 0/10 • Serious adverse events that occur from signing of informed consent through 30 days after the last dose of treatment, up to 6 months	0.00% 0/10 • Serious adverse events that occur from signing of informed consent through 30 days after the last dose of treatment, up to 6 months	10.0% 1/10 • Number of events 1 • Serious adverse events that occur from signing of informed consent through 30 days after the last dose of treatment, up to 6 months
Gastrointestinal disorders Nausea	0.00% 0/10 • Serious adverse events that occur from signing of informed consent through 30 days after the last dose of treatment, up to 6 months	0.00% 0/10 • Serious adverse events that occur from signing of informed consent through 30 days after the last dose of treatment, up to 6 months	10.0% 1/10 • Number of events 1 • Serious adverse events that occur from signing of informed consent through 30 days after the last dose of treatment, up to 6 months

Additional Information

Edward V Maytin

Cleveland Clinic, Dermatology and Plastic Surgery Institute, Case Comprehensive Cancer Center

Phone: (216) 445-6676

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Regimen A n=10 Participants Apply topical aminolevulinic acid gel and incubate for 10 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2	Regimen B n=10 Participants Apply topical aminolevulinic acid gel and incubate for 20 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2	Regimen C n=10 Participants Apply topical aminolevulinic acid gel and incubate for 60 minutes prior to red light source Topical aminolevulinate (10% ALA gel): 10% ALA gel to the entire face, without occlusion, followed by a prespecified incubation period Red light illumination: Illumination of red light of narrow spectrum of 635 nm with a light dose of approximately 37 J/cm2	Total n=30 Participants Total of all reporting groups
Age, Continuous	69.3 years STANDARD_DEVIATION 7.4 • n=5 Participants	69.9 years STANDARD_DEVIATION 7.0 • n=7 Participants	71.2 years STANDARD_DEVIATION 5.8 • n=5 Participants	70.1 years STANDARD_DEVIATION 0.97 • n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	10 Participants n=7 Participants	7 Participants n=5 Participants	26 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	27 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	30 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
History of skin cancer	9 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	24 Participants n=4 Participants
AK lesions	54.8 Lesions STANDARD_DEVIATION 24.3 • n=5 Participants	37.1 Lesions STANDARD_DEVIATION 17.3 • n=7 Participants	46.3 Lesions STANDARD_DEVIATION 17.3 • n=5 Participants	46.07 Lesions STANDARD_DEVIATION 8.85 • n=4 Participants
AKs previously	10 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	30 Participants n=4 Participants