Actinic Keratosis
Conditions
Keywords
aminolevulinic acid, pdt, photodynamic therapy, Photochemotherapy
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 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.
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 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 * 3 month follow up visit \- facial map of actinic keratoses used to document treatment response * 6 month follow up visit * facial map of actinic keratoses used to document treatment response
Interventions
DRUGAminolevulinic Acid
Topical application followed by activation by ambient sunlight
Sponsors
University of California, Irvine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in the Number of Actinic Keratoses | 0 (baseline) and 6 months | Percent change in number of actinic keratoses at 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 2 days | Number of participants with adverse events such as crusting, erythema, edema, or pain |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Aminolevulinic Acid With Daylight Photodynamic Therapy Arm | — |
|---|---|---|
| Actinic keratoses | 36.4 Actinic keratoses | — |
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 23 Participants | — |
| Age, Categorical Between 18 and 65 years | 7 Participants | — |
| Age, Continuous | 68.5 years | — |
| Average ambient lux | 8,244 lux | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 30 participants | — |
| Sex: Female, Male Female | 2 Participants | — |
| Sex: Female, Male Male | 28 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 3 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Percent Change in the Number of Actinic Keratoses
Percent change in number of actinic keratoses at 6 months
Time frame: 0 (baseline) and 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Aminolevulinic Acid With Daylight Photodynamic Therapy Arm | Percent Change in the Number of Actinic Keratoses | -75 % change in number of actinic keratoses |
Secondary
Number of Participants With Adverse Events
Number of participants with adverse events such as crusting, erythema, edema, or pain
Time frame: 2 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aminolevulinic Acid With Daylight Photodynamic Therapy Arm | Number of Participants With Adverse Events | 3 participants |