Comparing Immune Responses to Topical Imiquimod

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Actinic Keratoses
• Intervention / Treatment: Drug: Imiquimod

• Study Type: Observational
• Enrollment (Anticipated): 110

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • University of California Davis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who will use topical imiquimod as standard of care and who are without immune-mediated systemic disease

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Drug: 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 Names: Aldara; Zyclara

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, Davis

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 16, 2021
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: March 4, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (ACTUAL): March 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 12, 2022
• Last Update Submitted That Met QC Criteria: July 8, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: imiquimod; aldara
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis; Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Adjuvants, Immunologic; Interferon Inducers; Imiquimod
• Other Study ID Numbers: 1646493

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No