Comparing Immune Responses to Topical Imiquimod

University of California (UC) Davis

Status: Terminated

Conditions: Actinic Keratoses

Treatments: Drug: Imiquimod

Study type: Observational

Funder types: Other

Identifiers

NCT04809662

1646493

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

6 participants in 1 patient group

Main cohort

Description:

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

Treatment:

Drug: Imiquimod