Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses
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ClinicalTrials.gov Identifier: NCT03327831 |
Recruitment Status :
Completed
First Posted : October 31, 2017
Last Update Posted : December 15, 2017
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Condition or disease | Intervention/treatment | Phase |
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Actinic Keratosis | Drug: Aminolevulinic Acid | Phase 4 |
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Initial Visit:
- study inclusion criteria reviewed
- consent forms reviewed
- creation of facial map for actinic keratoses
- face cleansed with chlorhexidine soap
- light curettage of precancerous skin lesions
- application of topical aminolevulinic acid (ALA)
- application of sunscreen
- patient then spends 2 hours outdoors in a shaded area
- after treatment the patient is to remain indoors for 48 hours
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3 month follow up visit
- facial map of actinic keratoses used to document treatment response
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6 month follow up visit
- facial map of actinic keratoses used to document treatment response
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 31 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | UCI 14-92 / HS#2015-1889: Phase IV Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses |
Study Start Date : | April 2015 |
Actual Primary Completion Date : | February 2017 |
Actual Study Completion Date : | July 2017 |

Arm | Intervention/treatment |
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Experimental: Open Label Treatment 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.
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Drug: Aminolevulinic Acid
Topical application followed by activation by ambient sunlight
Other Name: Kerastick |
- The change in the number of Actinic Keratoses [ Time Frame: 0, 3, and 6 months ]The the change in number of actinic keratoses at time 0 and 6 months treatment will be measured as the primary outcome
- Adverse events [ Time Frame: 0, 3, and 6 months ]Measurement of crusting, erythema, edema, and pain
- Lux Correlation [ Time Frame: 0, 3, and 6 months ]Ambient lux from sunlight is measured during treatment and will be analyzed to determine if it contributes to treatment efficacy

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Clinical diagnosis of >10 actinic keratoses on head and neck
- Age ≥ 18 years (Because no dosing or adverse event data are currently available on the use of topical aminolevulinic acid in patients <18 years of age, children are excluded from this study)
- Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria:
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Patients currently undergoing anti-neoplastic therapy including but not limited to the following:
- Topical imiquimod
- Topical 5-fluorouracil
- Topical ingenol mebutate
- Topical diclofenac
- Topical retinoids
- Oral acitretin
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to aminolevulinic acid
- Patients with a known photosensitivity disorder including but not limited to porphyria, lupus, polymorphous light eruption, or immunobullous disease.
- Patients taking known photosensitizing medications including but not limited to griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides and tetracyclines.
- pregnancy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03327831
United States, California | |
University of California, Irvine | |
Irvine, California, United States, 92697-2400 |
Principal Investigator: | Christopher B Zachary, MBBS. FRC[ | University of California, Irvine |
Responsible Party: | Christopher Zachary, Principal Investigator, University of California, Irvine |
ClinicalTrials.gov Identifier: | NCT03327831 |
Other Study ID Numbers: |
2015-1889 |
First Posted: | October 31, 2017 Key Record Dates |
Last Update Posted: | December 15, 2017 |
Last Verified: | December 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
aminolevulinic acid pdt photodynamic therapy Photochemotherapy |
Keratosis, Actinic Keratosis Skin Diseases Precancerous Conditions |
Neoplasms Aminolevulinic Acid Photosensitizing Agents Dermatologic Agents |