Comparing Immune Responses to Topical Imiquimod

Terminated

• Conditions: Actinic Keratoses
• Interventions: Drug: Imiquimod

• Registration Number: NCT04809662
• Lead Sponsor: University of California, Davis

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-04
• Study Start: 2021-03-16
• Study First Submitted QC: 2021-03-18
• Study First Posted: 2021-03-22
• Primary Completion: 2023-11-07
• Study Completion: 2023-11-07
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Main cohort	Imiquimod	This is a split-body study, with patients acting as their own controls between lesional and nonlesional skin. All patients will apply imiquimod.

Primary Outcome Measures

Name	Time	Method
Immune response	5 years	RNA sequencing of patients to gauge immune response as measured by expression of key inflammatory cytokines related to TLR7 response generated by imiquimod.

Secondary Outcome Measures

Name	Time	Method
Monitoring	1 year	Incidence of treatment-related adverse events
Flow cytometry	3 years	Flow cytometry measurement of cell populations in patients after imiquimod
Immunohistochemistry	3 years	Immunohistochemical staining of patient biopsies using immune cell stains: CD3, CD4, CD8, CD68

Trial Locations

Locations (1)

University of California Davis; 🇺🇸 Sacramento, California, United States