Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
6 participants
OBSERVATIONAL
2021-03-16
2023-11-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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.
Imiquimod
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.
Interventions
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Imiquimod
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with a diagnosis that will result in treatment with imiquimod as standard of care, specifically actinic keratosis
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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University of California, Davis
OTHER
Responsible Party
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Locations
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University of California Davis
Sacramento, California, United States
Countries
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Other Identifiers
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1646493
Identifier Type: -
Identifier Source: org_study_id
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