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PI failed to submit the study for continuing review to IRB, failed to respond.
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The study is a basic science research study that is designed to characterize and compare the immune response in individuals who are designated as ABO blood group secretors, meaning they have a functional copy of the FUT2 gene versus those patients who are designated ABO non-secretors after application of topical imiquimod to these patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main cohort | This is a split-body study, with patients acting as their own controls between lesional and nonlesional skin. All patients will apply imiquimod. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imiquimod | Drug | Patients with a diagnosis of actinic keratosis or warts that would be prescribed imiquimod as standard of care will be asked to apply 2 packets (or 2 full pumps) of imiquimod once daily before bedtime for two weeks and then leave on overnight for ~8 hours. (a) A biopsy will be performed at the baseline visit on the pre-treatment skin and the skin where the medication will not be applied. The skin where the medication will not be applied will act as the negative control. A biopsy will then again be performed on day 10 of imiquimod treatment on the treated skin only, where the study drug was applied. |
| Measure | Description | Time Frame |
|---|---|---|
| Immune response | RNA sequencing of patients to gauge immune response as measured by expression of key inflammatory cytokines related to TLR7 response generated by imiquimod. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Monitoring | Incidence of treatment-related adverse events | 1 year |
| Flow cytometry | Flow cytometry measurement of cell populations in patients after imiquimod |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who will use topical imiquimod as standard of care and who are without immune-mediated systemic disease
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Davis | Sacramento | California | 95816 | 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 |
|---|---|
| D000077271 | Imiquimod |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Skin biopsies
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| 3 years |
| Immunohistochemistry | Immunohistochemical staining of patient biopsies using immune cell stains: CD3, CD4, CD8, CD68 | 3 years |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006571 | Heterocyclic Compounds |