Comparing Immune Responses to Topical Imiquimod

Sponsor

University of California, Davis (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04809662

Collaborator

(none)

110

Enrollment

Location

20.5

Anticipated Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Actinic Keratoses	Drug: Imiquimod

Study Design

Study Type:

Observational

Anticipated Enrollment :

110 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Comparing Immune Responses to Topical Imiquimod

Actual Study Start Date :

Mar 16, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California Davis	Sacramento	California	United States	95816

Sponsors and Collaborators

University of California, Davis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Emanual Maverakis, MD, Professor, University of California, Davis

ClinicalTrials.gov Identifier:

NCT04809662

Other Study ID Numbers:

1646493

First Posted:

Mar 22, 2021

Last Update Posted:

Jul 12, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Emanual Maverakis, MD, Professor, University of California, Davis

imiquimod

aldara

Additional relevant MeSH terms:

Keratosis, Actinic

Keratosis

Imiquimod

Study Results

No Results Posted as of Jul 12, 2022