Trial Outcomes & Findings for Daylight Photodynamic Therapy for Actinic Keratosis (NCT NCT03322293)

Last Updated: 2022-03-09

Results Overview

Primary objective is to determine whether daylight PDT changes treatment symptoms of pain, stinging/burning, and itching/pruritus. This was measured using a visual analog scale from 0-10, with higher scores indicating worse treatment symptoms, or more pain/burning/itching. Lower scores indicate less pain, burning/stinging, and itching/pruritus. Positive numbers represent increases in symptoms and negative numbers represent decreases.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

24 participants

Primary outcome timeframe

12 weeks

Results posted on

2022-03-09

Participant Flow

Participant milestones

Participant milestones
Measure	A. Conventional Arm This is considered the standard of care arm for photodynamic therapy for the treatment of actinic keratosis. This treatment arm includes: Acetone preparation, ALA topical application, 1 hour incubation, 16 minutes 40 seconds (16:40) BLU-U exposure, application of sunscreen. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C). BLU-U blue light phototherapy illuminator: Depending on the treatment arm, subjects will either receive BLU-U exposure or not. Treatment arms A and B have BLU-U exposure and treatment arm C does not.	B. Combination Arm This treatment arm combines standard of care BLU-U exposure and daylight exposure. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, 16:40 BLU-U exposure, application of sunscreen, 45 minute daylight exposure. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C). BLU-U blue light phototherapy illuminator: Depending on the treatment arm, subjects will either receive BLU-U exposure or not. Treatment arms A and B have BLU-U exposure and treatment arm C does not.	C. Daylight Arm This is the experimental arm. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, application of sunscreen, 1 hour daylight exposure. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: none Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C).
Overall Study STARTED	8	8	8
Overall Study COMPLETED	8	8	7
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	A. Conventional Arm This is considered the standard of care arm for photodynamic therapy for the treatment of actinic keratosis. This treatment arm includes: Acetone preparation, ALA topical application, 1 hour incubation, 16 minutes 40 seconds (16:40) BLU-U exposure, application of sunscreen. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C). BLU-U blue light phototherapy illuminator: Depending on the treatment arm, subjects will either receive BLU-U exposure or not. Treatment arms A and B have BLU-U exposure and treatment arm C does not.	B. Combination Arm This treatment arm combines standard of care BLU-U exposure and daylight exposure. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, 16:40 BLU-U exposure, application of sunscreen, 45 minute daylight exposure. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C). BLU-U blue light phototherapy illuminator: Depending on the treatment arm, subjects will either receive BLU-U exposure or not. Treatment arms A and B have BLU-U exposure and treatment arm C does not.	C. Daylight Arm This is the experimental arm. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, application of sunscreen, 1 hour daylight exposure. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: none Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C).
Overall Study Lost to Follow-up	0	0	1

Baseline Characteristics

Daylight Photodynamic Therapy for Actinic Keratosis

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 12 weeks

Population: 24 participants enrolled in the study who underwent treatment were analyzed.

Outcome measures

Outcome measures
Measure	A. Conventional Arm n=8 Participants This is considered the standard of care arm for photodynamic therapy for the treatment of actinic keratosis. This treatment arm includes: Acetone preparation, ALA topical application, 1 hour incubation, 16 minutes 40 seconds (16:40) BLU-U exposure, application of sunscreen. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C). BLU-U blue light phototherapy illuminator: Depending on the treatment arm, subjects will either receive BLU-U exposure or not. Treatment arms A and B have BLU-U exposure and treatment arm C does not.	B. Combination Arm n=8 Participants This treatment arm combines standard of care BLU-U exposure and daylight exposure. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, 16:40 BLU-U exposure, application of sunscreen, 45 minute daylight exposure. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C). BLU-U blue light phototherapy illuminator: Depending on the treatment arm, subjects will either receive BLU-U exposure or not. Treatment arms A and B have BLU-U exposure and treatment arm C does not.	C. Daylight Arm n=8 Participants This is the experimental arm. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, application of sunscreen, 1 hour daylight exposure. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: none Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C).
Change in Treatment Symptoms	3.9 score on a scale Interval 3.11 to 4.63	0.5 score on a scale Interval -0.26 to 1.26	0.37 score on a scale Interval -0.38 to 1.13

SECONDARY outcome

Timeframe: 12 weeks

Population: 24 participants who underwent treatment were analyzed, with the data for the 1 participant in group C who was lost-to-follow up carried forward. This means that data for 8 participants in each subgroup and 24 participants overall was analyzed for this outcome.

The number of actinic keratoses within the treatment area was counted both pre and post-treatment. Then, the mean percent change from baseline actinic keratosis lesion count was calculated for each treatment group.

Outcome measures

Outcome measures
Measure	A. Conventional Arm n=8 Participants This is considered the standard of care arm for photodynamic therapy for the treatment of actinic keratosis. This treatment arm includes: Acetone preparation, ALA topical application, 1 hour incubation, 16 minutes 40 seconds (16:40) BLU-U exposure, application of sunscreen. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C). BLU-U blue light phototherapy illuminator: Depending on the treatment arm, subjects will either receive BLU-U exposure or not. Treatment arms A and B have BLU-U exposure and treatment arm C does not.	B. Combination Arm n=8 Participants This treatment arm combines standard of care BLU-U exposure and daylight exposure. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, 16:40 BLU-U exposure, application of sunscreen, 45 minute daylight exposure. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C). BLU-U blue light phototherapy illuminator: Depending on the treatment arm, subjects will either receive BLU-U exposure or not. Treatment arms A and B have BLU-U exposure and treatment arm C does not.	C. Daylight Arm n=8 Participants This is the experimental arm. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, application of sunscreen, 1 hour daylight exposure. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: none Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C).
Percent Change in AK Lesion Count	63.9 percent change Standard Deviation 24.9	66.4 percent change Standard Deviation 29.5	61.8 percent change Standard Deviation 59.9

SECONDARY outcome

Timeframe: 12 weeks

Population: 24 participants who underwent treatment were analyzed, with data from the 1 participant in group C who was lost to follow up carried forward. 8 Participants were included in data analysis for each subgroup, with 24 participants included overall.

The number of AK lesions within the treatment area was assessed both pre and post-treatment. Then, the number of participants with various levels of AK lesion reduction (100% reduction or greater than 75% reduction) was calculated for each treatment group. This outcome measures the proportion of subjects with complete (100%) and partial (greater than or equal to 75%) reduction of baseline actinic keratosis lesion counts at 12 weeks (study end).

Outcome measures

Outcome measures
Measure	A. Conventional Arm n=8 Participants This is considered the standard of care arm for photodynamic therapy for the treatment of actinic keratosis. This treatment arm includes: Acetone preparation, ALA topical application, 1 hour incubation, 16 minutes 40 seconds (16:40) BLU-U exposure, application of sunscreen. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C). BLU-U blue light phototherapy illuminator: Depending on the treatment arm, subjects will either receive BLU-U exposure or not. Treatment arms A and B have BLU-U exposure and treatment arm C does not.	B. Combination Arm n=8 Participants This treatment arm combines standard of care BLU-U exposure and daylight exposure. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, 16:40 BLU-U exposure, application of sunscreen, 45 minute daylight exposure. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C). BLU-U blue light phototherapy illuminator: Depending on the treatment arm, subjects will either receive BLU-U exposure or not. Treatment arms A and B have BLU-U exposure and treatment arm C does not.	C. Daylight Arm n=8 Participants This is the experimental arm. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, application of sunscreen, 1 hour daylight exposure. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: none Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C).
Reduction of AK Counts Partial Clearance	2 Participants	3 Participants	5 Participants
Reduction of AK Counts Complete Clearance	2 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: 24 participants who underwent treatment were analyzed, with data from the 1 participant lost to follow up in Group C carried forward. 8 participants were analyzed for each subgroup, with 24 participants analyzed overall.

To determine whether daylight PDT affords a reduction in local skin reaction to treatment. A Local Skin Response Assessment scale will be used to measure this outcome. The investigators will grade categories including Erythema, Flaking/Scaling, crusting, swelling, Pustulation (pustules), and Erosion, on a 0-4 scale (total maximum score of 24). A higher score indicates more erythema, flaking, crusting, etc. and therefore a more robust skin reaction. A score of 0 represents no erythema, flaking, crusting, etc.

Outcome measures

Outcome measures
Measure	A. Conventional Arm n=8 Participants This is considered the standard of care arm for photodynamic therapy for the treatment of actinic keratosis. This treatment arm includes: Acetone preparation, ALA topical application, 1 hour incubation, 16 minutes 40 seconds (16:40) BLU-U exposure, application of sunscreen. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C). BLU-U blue light phototherapy illuminator: Depending on the treatment arm, subjects will either receive BLU-U exposure or not. Treatment arms A and B have BLU-U exposure and treatment arm C does not.	B. Combination Arm n=8 Participants This treatment arm combines standard of care BLU-U exposure and daylight exposure. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, 16:40 BLU-U exposure, application of sunscreen, 45 minute daylight exposure. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C). BLU-U blue light phototherapy illuminator: Depending on the treatment arm, subjects will either receive BLU-U exposure or not. Treatment arms A and B have BLU-U exposure and treatment arm C does not.	C. Daylight Arm n=8 Participants This is the experimental arm. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, application of sunscreen, 1 hour daylight exposure. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: none Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C).
Change in Local Skin Reaction From Pre-treatment to 12 Weeks Post-treatment	1.0 score on a scale Interval 0.12 to 1.88	1.25 score on a scale Interval 0.37 to 2.13	1.0 score on a scale Interval 0.07 to 1.93

SECONDARY outcome

Timeframe: 8 days post-treatment

Population: 24 participants who underwent treatment were analyzed, with data from the 1 participant from Group C who was lost to follow up carried forward. 8 participants from each subgroup were analyzed, with 24 participants overall. Mean peak pain on day 8 with a 95% confidence interval for each treatment group on day 8 is reported below.

Pain was measured by patient report with a visual analog scale from 0-10. 0 indicates no pain and 10 indicates the maximum pain score.

Outcome measures

Outcome measures
Measure	A. Conventional Arm n=8 Participants This is considered the standard of care arm for photodynamic therapy for the treatment of actinic keratosis. This treatment arm includes: Acetone preparation, ALA topical application, 1 hour incubation, 16 minutes 40 seconds (16:40) BLU-U exposure, application of sunscreen. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C). BLU-U blue light phototherapy illuminator: Depending on the treatment arm, subjects will either receive BLU-U exposure or not. Treatment arms A and B have BLU-U exposure and treatment arm C does not.	B. Combination Arm n=8 Participants This treatment arm combines standard of care BLU-U exposure and daylight exposure. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, 16:40 BLU-U exposure, application of sunscreen, 45 minute daylight exposure. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C). BLU-U blue light phototherapy illuminator: Depending on the treatment arm, subjects will either receive BLU-U exposure or not. Treatment arms A and B have BLU-U exposure and treatment arm C does not.	C. Daylight Arm n=8 Participants This is the experimental arm. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, application of sunscreen, 1 hour daylight exposure. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: none Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C).
Peak Pain Score at Day 8 Post-treatment	3.5 score on a scale Interval 2.62 to 4.38	5.13 score on a scale Interval 4.25 to 6.0	4.00 score on a scale Interval 3.07 to 4.93

Adverse Events

A. Conventional Arm

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

B. Combination Arm

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

C. Daylight Arm

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	A. Conventional Arm n=8 participants at risk This is considered the standard of care arm for photodynamic therapy for the treatment of actinic keratosis. This treatment arm includes: Acetone preparation, ALA topical application, 1 hour incubation, 16 minutes 40 seconds (16:40) BLU-U exposure, application of sunscreen. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C). BLU-U blue light phototherapy illuminator: Depending on the treatment arm, subjects will either receive BLU-U exposure or not. Treatment arms A and B have BLU-U exposure and treatment arm C does not.	B. Combination Arm n=8 participants at risk This treatment arm combines standard of care BLU-U exposure and daylight exposure. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, 16:40 BLU-U exposure, application of sunscreen, 45 minute daylight exposure. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C). BLU-U blue light phototherapy illuminator: Depending on the treatment arm, subjects will either receive BLU-U exposure or not. Treatment arms A and B have BLU-U exposure and treatment arm C does not.	C. Daylight Arm n=8 participants at risk This is the experimental arm. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, application of sunscreen, 1 hour daylight exposure. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: none Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C).
Skin and subcutaneous tissue disorders Pruritus in Treatment Area	25.0% 2/8 • Number of events 2 • Adverse event data were collected from enrollment of first participant in Decomber 2017 through completion of final participant in September 2018. Adverse events were monitored for each patient from treatment up until 84 days following treatment. Adverse events were collected at study visits by asking the participants and eliciting any relevant patient-reported adverse event information. Adverse events were defined using Common Terminology Criteria version 5.0.	62.5% 5/8 • Number of events 5 • Adverse event data were collected from enrollment of first participant in Decomber 2017 through completion of final participant in September 2018. Adverse events were monitored for each patient from treatment up until 84 days following treatment. Adverse events were collected at study visits by asking the participants and eliciting any relevant patient-reported adverse event information. Adverse events were defined using Common Terminology Criteria version 5.0.	37.5% 3/8 • Number of events 3 • Adverse event data were collected from enrollment of first participant in Decomber 2017 through completion of final participant in September 2018. Adverse events were monitored for each patient from treatment up until 84 days following treatment. Adverse events were collected at study visits by asking the participants and eliciting any relevant patient-reported adverse event information. Adverse events were defined using Common Terminology Criteria version 5.0.
Skin and subcutaneous tissue disorders Burning/Pain in Treatment Area	62.5% 5/8 • Number of events 5 • Adverse event data were collected from enrollment of first participant in Decomber 2017 through completion of final participant in September 2018. Adverse events were monitored for each patient from treatment up until 84 days following treatment. Adverse events were collected at study visits by asking the participants and eliciting any relevant patient-reported adverse event information. Adverse events were defined using Common Terminology Criteria version 5.0.	12.5% 1/8 • Number of events 1 • Adverse event data were collected from enrollment of first participant in Decomber 2017 through completion of final participant in September 2018. Adverse events were monitored for each patient from treatment up until 84 days following treatment. Adverse events were collected at study visits by asking the participants and eliciting any relevant patient-reported adverse event information. Adverse events were defined using Common Terminology Criteria version 5.0.	37.5% 3/8 • Number of events 3 • Adverse event data were collected from enrollment of first participant in Decomber 2017 through completion of final participant in September 2018. Adverse events were monitored for each patient from treatment up until 84 days following treatment. Adverse events were collected at study visits by asking the participants and eliciting any relevant patient-reported adverse event information. Adverse events were defined using Common Terminology Criteria version 5.0.
Skin and subcutaneous tissue disorders Scaling	37.5% 3/8 • Number of events 3 • Adverse event data were collected from enrollment of first participant in Decomber 2017 through completion of final participant in September 2018. Adverse events were monitored for each patient from treatment up until 84 days following treatment. Adverse events were collected at study visits by asking the participants and eliciting any relevant patient-reported adverse event information. Adverse events were defined using Common Terminology Criteria version 5.0.	0.00% 0/8 • Adverse event data were collected from enrollment of first participant in Decomber 2017 through completion of final participant in September 2018. Adverse events were monitored for each patient from treatment up until 84 days following treatment. Adverse events were collected at study visits by asking the participants and eliciting any relevant patient-reported adverse event information. Adverse events were defined using Common Terminology Criteria version 5.0.	37.5% 3/8 • Number of events 3 • Adverse event data were collected from enrollment of first participant in Decomber 2017 through completion of final participant in September 2018. Adverse events were monitored for each patient from treatment up until 84 days following treatment. Adverse events were collected at study visits by asking the participants and eliciting any relevant patient-reported adverse event information. Adverse events were defined using Common Terminology Criteria version 5.0.
Skin and subcutaneous tissue disorders Erythema in Treatment Area	25.0% 2/8 • Number of events 2 • Adverse event data were collected from enrollment of first participant in Decomber 2017 through completion of final participant in September 2018. Adverse events were monitored for each patient from treatment up until 84 days following treatment. Adverse events were collected at study visits by asking the participants and eliciting any relevant patient-reported adverse event information. Adverse events were defined using Common Terminology Criteria version 5.0.	25.0% 2/8 • Number of events 2 • Adverse event data were collected from enrollment of first participant in Decomber 2017 through completion of final participant in September 2018. Adverse events were monitored for each patient from treatment up until 84 days following treatment. Adverse events were collected at study visits by asking the participants and eliciting any relevant patient-reported adverse event information. Adverse events were defined using Common Terminology Criteria version 5.0.	25.0% 2/8 • Number of events 2 • Adverse event data were collected from enrollment of first participant in Decomber 2017 through completion of final participant in September 2018. Adverse events were monitored for each patient from treatment up until 84 days following treatment. Adverse events were collected at study visits by asking the participants and eliciting any relevant patient-reported adverse event information. Adverse events were defined using Common Terminology Criteria version 5.0.

Additional Information

Dr. Sarah Arron, MD, PhD

University of California San Francisco Dept. of Dermatology

Phone: 415-353-9684

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	A. Conventional Arm n=8 Participants This is considered the standard of care arm for photodynamic therapy for the treatment of actinic keratosis. This treatment arm includes: Acetone preparation, ALA topical application, 1 hour incubation, 16 minutes 40 seconds (16:40) BLU-U exposure, application of sunscreen. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C). BLU-U blue light phototherapy illuminator: Depending on the treatment arm, subjects will either receive BLU-U exposure or not. Treatment arms A and B have BLU-U exposure and treatment arm C does not.	B. Combination Arm n=8 Participants This treatment arm combines standard of care BLU-U exposure and daylight exposure. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, 16:40 BLU-U exposure, application of sunscreen, 45 minute daylight exposure. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C). BLU-U blue light phototherapy illuminator: Depending on the treatment arm, subjects will either receive BLU-U exposure or not. Treatment arms A and B have BLU-U exposure and treatment arm C does not.	C. Daylight Arm n=8 Participants This is the experimental arm. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, application of sunscreen, 1 hour daylight exposure. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: none Aminolevulinic Acid Topical 20% Topical Solution: PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C).	Total n=24 Participants Total of all reporting groups
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	24 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	8 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	23 Participants n=4 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	21 Participants n=4 Participants
Age, Continuous	71.9 years n=5 Participants	77.7 years n=7 Participants	75.0 years n=5 Participants	75 years n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (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
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	8 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	24 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
Region of Enrollment United States	8 participants n=5 Participants	8 participants n=7 Participants	8 participants n=5 Participants	24 participants n=4 Participants
Treatment Area Face	5 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	17 Participants n=4 Participants
Treatment Area Scalp	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Actinic Keratosis Count	12.1 lesion count STANDARD_DEVIATION 4.2 • n=5 Participants	11.3 lesion count STANDARD_DEVIATION 3.0 • n=7 Participants	10.3 lesion count STANDARD_DEVIATION 3.7 • n=5 Participants	10.8 lesion count STANDARD_DEVIATION 4.9 • n=4 Participants