Clinical trial · Interventional
Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses
UCI 14-92 / HS#2015-1889: Phase IV Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aminolevulinic Acid | Drug | Aminolevulinic Acid | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Aminolevulinic Acid with daylight photodynamic therapy arm
- description
- 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.
- interventionNames
- Drug: Aminolevulinic Acid
Primary outcomes (1)
- measure
- Percent Change in the Number of Actinic Keratoses
- timeFrame
- 0 (baseline) and 6 months
- description
- Percent change in number of actinic keratoses at 6 months
Secondary outcomes (1)
- measure
- Number of Participants With Adverse Events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available