Status:
COMPLETED
Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses
Lead Sponsor:
University of California, Irvine
Conditions:
Actinic Keratosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Photodynamic therapy is an effective treatment for actinic keratoses. In the United States topical aminolevulinic acid (ALA) is approved as a photosensitizing agent for this treatment, and it has trad...
Detailed Description
* Initial Visit: * study inclusion criteria reviewed * consent forms reviewed * creation of facial map for actinic keratoses * face cleansed with chlorhexidine soap * light curettage of pre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03327831
Start Date
April 1 2015
End Date
July 1 2017
Last Update
June 27 2024
Active Locations (1)
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1
University of California, Irvine
Irvine, California, United States, 92697-2400