Clinical trial · Observational
Comparing Immune Responses to Topical Imiquimod
NCT04809662CI-TRIAL-00082336terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI failed to submit the study for continuing review to IRB, failed to respond.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratoses | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imiquimod | Drug | Imiquimod | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Drug: Imiquimod
Primary outcomes (1)
- measure
- Immune response
- timeFrame
- 5 years
- description
- RNA sequencing of patients to gauge immune response as measured by expression of key inflammatory cytokines related to TLR7 response generated by imiquimod.
Secondary outcomes (3)
- measure
- Monitoring
- timeFrame
- 1 year
- description
- Incidence of treatment-related adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.