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This is a randomized clinical trial evaluating blue light 5-aminolevulinic acid (ALA) photodynamic therapy with different incubation times for the treatment of actinic keratosis.
Subjects who are interested in participating, currently living in the Chicago metropolitan area, and meet inclusion and exclusion criteria will be enrolled in the study. Subjects will be randomized to either 1) zero time ALA incubation or 2) 1 hour ALA incubation. Demographic and health data will be collected prior to treatment initiation. Three visits will be conducted: screening, treatment, and follow up visit at 8 weeks.
This study is a pilot study designed to determine feasibility of this procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zero incubation with ALA (5-aminolevulinic acid) | Experimental | Subjects will receive zero time of incubation with ALA (5-aminolevulinic acid) before photodynamic blue light therapy. |
|
| One hour incubation with ALA (5-aminolevulinic acid) | Experimental | Subjects will receive one hour of incubation with ALA (5-aminolevulinic acid) before photodynamic blue light therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALA (5-aminolevulinic acid) | Drug | ALA (5-aminolevulinic acid) will be applied to subjects' skin for either zero time incubation or one hour incubation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in number of Actinic Keratosis (AK) lesions | The number of AK lesions will be counted by a live, blinded assessor at baseline and at Week 8 follow-up visit. | Baseline and 8 Weeks |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Murad Alam, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine, Department of Dermatology | Chicago | Illinois | 60611 | United States |
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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 |
| D010789 | Phototherapy |
| ID | Term |
|---|---|
| D007982 | Levulinic Acids |
| D007651 | Keto Acids |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Blue light therapy | Device | Subjects will be exposed to blue light |
|
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013812 | Therapeutics |