Trial Outcomes & Findings for Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses (NCT NCT03327831)

NCT ID: NCT03327831

Last Updated: 2024-06-27

Results Overview

Percent change in number of actinic keratoses at 6 months

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 30 participants
• Primary outcome timeframe: 0 (baseline) and 6 months
• Results posted on: 2024-06-27

Participant Flow

Participant milestones

Measure	Aminolevulinic Acid With Daylight Photodynamic Therapy Arm This study has a single, open label treatment arm. Patients will have topical aminolevulinic acid applied to the actinic keratoses in the treatment area (face/scalp) and will spend 2 hours outdoors in the shade to activate the medication. The patient then follow up in clinic 3 months and 6 months after their treatment to have the number of actinic keratoses counted. Aminolevulinic Acid: Topical application followed by activation by ambient sunlight
Overall Study STARTED	30
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure

Aminolevulinic Acid With Daylight Photodynamic Therapy Arm This study has a single, open label treatment arm. Patients will have topical aminolevulinic acid applied to the actinic keratoses in the treatment area (face/scalp) and will spend 2 hours outdoors in the shade to activate the medication. The patient then follow up in clinic 3 months and 6 months after their treatment to have the number of actinic keratoses counted. Aminolevulinic Acid: Topical application followed by activation by ambient sunlight

Overall Study Lost to Follow-up

2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Aminolevulinic Acid With Daylight Photodynamic Therapy Arm n=30 Participants This study has a single, open label treatment arm. Patients will have topical aminolevulinic acid applied to the actinic keratoses in the treatment area (face/scalp) and will spend 2 hours outdoors in the shade to activate the medication. The patient then follow up in clinic 3 months and 6 months after their treatment to have the number of actinic keratoses counted. Aminolevulinic Acid: Topical application followed by activation by ambient sunlight
Age, Categorical <=18 years	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=30 Participants
Age, Categorical >=65 years	23 Participants n=30 Participants
Age, Continuous	68.5 years n=30 Participants
Sex: Female, Male Female	2 Participants n=30 Participants
Sex: Female, Male Male	28 Participants n=30 Participants
Region of Enrollment United States	30 participants n=30 Participants
Actinic keratoses	36.4 Actinic keratoses n=30 Participants
Average ambient lux	8,244 lux n=30 Participants

PRIMARY outcome

Timeframe: 0 (baseline) and 6 months

Percent change in number of actinic keratoses at 6 months

Outcome measures

Measure

Aminolevulinic Acid With Daylight Photodynamic Therapy Arm n=105 actinic keratosis This study has a single, open label treatment arm. Patients will have topical aminolevulinic acid applied to the actinic keratoses in the treatment area (face/scalp) and will spend 2 hours outdoors in the shade to activate the medication. The patient then follow up in clinic 3 months and 6 months after their treatment to have the number of actinic keratoses counted. Aminolevulinic Acid: Topical application followed by activation by ambient sunlight

Percent Change in the Number of Actinic Keratoses

-75 % change in number of actinic keratoses Interval -92.0 to -35.0

SECONDARY outcome

Timeframe: 2 days

Number of participants with adverse events such as crusting, erythema, edema, or pain

Outcome measures

Measure

Aminolevulinic Acid With Daylight Photodynamic Therapy Arm n=30 Participants This study has a single, open label treatment arm. Patients will have topical aminolevulinic acid applied to the actinic keratoses in the treatment area (face/scalp) and will spend 2 hours outdoors in the shade to activate the medication. The patient then follow up in clinic 3 months and 6 months after their treatment to have the number of actinic keratoses counted. Aminolevulinic Acid: Topical application followed by activation by ambient sunlight

Number of Participants With Adverse Events

3 participants

Adverse Events

Aminolevulinic Acid With Daylight Photodynamic Therapy Arm

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Aminolevulinic Acid With Daylight Photodynamic Therapy Arm n=30 participants at risk This study has a single, open label treatment arm. Patients will have topical aminolevulinic acid applied to the actinic keratoses in the treatment area (face/scalp) and will spend 2 hours outdoors in the shade to activate the medication. The patient then follow up in clinic 3 months and 6 months after their treatment to have the number of actinic keratoses counted. Aminolevulinic Acid: Topical application followed by activation by ambient sunlight
Skin and subcutaneous tissue disorders Pruritus	6.7% 2/30 • Number of events 2 • 6 months
Skin and subcutaneous tissue disorders Pustules	3.3% 1/30 • Number of events 1 • 6 months

Additional Information

Christopher Zachary

UC Irvine

Phone: 949-824-5515

Email: czachary@uci.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place