Comparing Immune Responses to Topical Imiquimod

Study Overview
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Brief Summary
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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.

Official Title
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Comparing Immune Responses to Topical Imiquimod

Conditions
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Actinic Keratoses

Intervention / Treatment
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* Drug: Imiquimod


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals between 18 to 85 years of age Patients with a diagnosis that will result in treatment with imiquimod as standard of care, specifically actinic keratosis Exclusion Criteria: Younger than 18 years or older than 85 years. History of hypersensitivity/ allergic reaction or adverse reaction to imiquimod Individuals with a diagnostic biopsy and supportive histology of a cutaneous immune-mediated disease (e.g. psoriasis and mycosis fungoides, etc.) or diseases of the hematopoietic system, liver and the gastrointestinal tract (e.g. aplastic anemia, Crohn's disease, Ulcerative Colitis, Primary Sclerosing Cholangitis (PSC), Primary Biliary Cirrhosis, acute and chronic graft versus host disease (GVHD)). Individuals with autoantibodies plus objective evidence of end organ damage related to a cutaneous immune-mediated disease (e.g. psoriasis and mycosis fungoides, etc.) or diseases of the hematopoietic system, liver and the gastrointestinal tract (e.g. aplastic anemia, Crohn's disease, Ulcerative Colitis, Primary Sclerosing Cholangitis (PSC), Primary Biliary Cirrhosis, acute and chronic graft versus host disease (GVHD)). Individuals with a history of serious infection within the last 6 months. Individuals with tuberculosis, HIV, or hepatitis B, or C. Patients unable to provide consent Incarcerated individuals

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Main cohort<br>This is a split-body study, with patients acting as their own controls between lesional and nonlesional skin. All patients will apply imiquimod. | Drug: Imiquimod<br>* 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.<br>* Other names: Zyclara;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 3 years | 
| Immunohistochemistry | Immunohistochemical staining of patient biopsies using immune cell stains: CD3, CD4, CD8, CD68 | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aldara, imiquimod