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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.
Initial Visit:
3 month follow up visit
- facial map of actinic keratoses used to document treatment response
6 month follow up visit
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aminolevulinic Acid with daylight photodynamic therapy arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aminolevulinic Acid | Drug | Topical application followed by activation by ambient sunlight |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in the Number of Actinic Keratoses | Percent change in number of actinic keratoses at 6 months | 0 (baseline) and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Number of participants with adverse events such as crusting, erythema, edema, or pain | 2 days |
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Inclusion Criteria:
Exclusion Criteria:
Patients currently undergoing anti-neoplastic therapy including but not limited to the following:
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
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| Name | Affiliation | Role |
|---|---|---|
| Christopher B Zachary, MBBS. FRC[ | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine | Irvine | California | 92697-2400 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in the Number of Actinic Keratoses | Percent change in number of actinic keratoses at 6 months | Posted | Median | Full Range | % change in number of actinic keratoses | 0 (baseline) and 6 months | actinic keratosis | actinic keratosis |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment | Pruritus of the skin |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Zachary | UC Irvine | 949-824-5515 | czachary@uci.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2015 | Dec 18, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000622 | Aminolevulinic Acid |
| ID | Term |
|---|---|
| D007982 | Levulinic Acids |
| D007651 | Keto Acids |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Actinic keratoses | Mean | Full Range | Actinic keratoses |
|
| Average ambient lux | Ambient lux, or a measure of luminous flux per unit area from sunlight, is measured during treatment and will be analyzed to determine it if contributes to treatment efficacy. Patients measure their lux with a handheld luxometer (Suncheck Instruments, Model HS1010 Sun Nuclear Corporation, Melbourne). | Mean | Full Range | lux |
|
| Units | Counts |
|---|
| Participants |
|
| actinic keratosis |
|
|
| Secondary | Number of Participants With Adverse Events | Number of participants with adverse events such as crusting, erythema, edema, or pain | Posted | Number | participants | 2 days |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 3 |
| 30 |
|
| Pustules | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |