Phase 4
N=30
Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses
Actinic Keratosis
Bottom Line
View on ClinicalTrials.gov: NCT03327831 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Percent Change in the Number of Actinic Keratoses — -75 % change in number of actinic keratoses
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Aminolevulinic Acid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Irvine
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in the Number of Actinic Keratoses |
-75 | — |
| SECONDARY Number of Participants With Adverse Events |
3 | — |
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 traditionally been activated with the use of an in-office artificial light source. This clinical trial seeks to measure the safety and efficacy of using natural sunlight to activate the ALA.
Eligibility Criteria
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
- 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
Data sourced from ClinicalTrials.gov (NCT03327831). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.