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The study never started due to the Principal Investigator leaving the institution
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The purpose of this study is to compare the treatment of skin growths called actinic keratoses (AK) with 5-ALA PDT, an FDA-approved treatment, versus treatment with other conventionally used FDA-approved agents such as cryotherapy, Imiquimod, or 5-fluorouracil (5-FU).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Application of 5-ALA PDT to some lesions on skin with "Blue U" light source (417 nm). |
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| 2 | Experimental | 5-FU, Imiquimod or treatment with cryotherapy to lesions on the skin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-ALA plus Blu-Light | Drug | 20% 5-ALA ampoules will be crushed and prepared for application after shaking for 3 minutes. Topical ALA will be applied liberally on skin with extra pressure on lesions. Incubation of ALA will take place for 0-3 hours. Exposure to Blue U light source (417 nm) (DUSA), will be performed for Actinic Keratosis for 15 minutes. Application of combination light sources will be performed when lesions are traced with one pass of Pulsed dye laser (595 nm) (Candela) followed by exposure to Blue U light source for 5-8 minutes pending response. |
| Measure | Description | Time Frame |
|---|---|---|
| Actinic keratosis /incomplete therapy and reoccurence | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Erythema | Early skin responses 2 weeks post therapy (erythema, scaling, post inflammatory skin changes, fine wrinkling of skin, mottled pigmentation) | 2 weeks post therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Tsoukas, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago | Chicago | Illinois | 60637 | 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 |
|---|---|
| D005472 | Fluorouracil |
| D000077271 | Imiquimod |
| D013812 | Therapeutics |
| D017679 | Cryotherapy |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| 5-FU, Imiquimod or treatment with cryotherapy | Drug | Cryotherapy will be performed on lesions only every 2 week intervals. Application of Imiquimod will be done on the treated skin area 5 days weekly for 4-6 weeks. 5-FU will be once daily on the treated areas 4- 6 weeks. Responses will be monitored every 2 weeks. |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D006571 |
| Heterocyclic Compounds |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |