Comparing Immune Responses to Topical Imiquimod

NCT04809662 | Terminated

• 1 other identifier: 1646493
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Actinic Keratoses

Keywords

imiquimod; aldara

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Monitoring

  1 year

• Flow cytometry

  3 years

• Immunohistochemistry

  3 years

Study Arms (1)

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

Interventions

Imiquimod DRUG

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.

Also known as: Aldara, Zyclara

Main cohort

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California Davis

Sacramento, California, 95816, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Skin biopsies

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 22, 2021
• Study Start: March 16, 2021
• Primary Completion: November 7, 2023
• Study Completion: November 7, 2023
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)