Actinic KeratosesNCT04809662
Comparing Immune Responses to Topical Imiquimod
An observational study of Actinic Keratoses, run by University of California, Davis at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Actinic Keratoses
- What is being tested?
- Imiquimod
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2021to 7 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will use topical imiquimod as standard of care and who are without immune-mediated systemic disease
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of California Davis
Sacramento, California, 95816
About this study
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
- Being tested
- Imiquimod
- Keywords
- imiquimod, aldara
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImiquimodDrug
Also called Aldara, Zyclara
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Imiquimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (3)
Monitoring
Incidence of treatment-related adverse events
Measured: 1 year
Flow cytometry
Flow cytometry measurement of cell populations in patients after imiquimod
Measured: 3 years
Immunohistochemistry
Immunohistochemical staining of patient biopsies using immune cell stains: CD3, CD4, CD8, CD68
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start16 Mar 2021
- Primary completion7 Nov 2023
- Study completion7 Nov 2023
Why it stopped: PI failed to submit the study for continuing review to IRB, failed to respond.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809662
- Sponsor's protocol ID
- 1646493
- Status last verified
- Nov 2024
- First submitted
- 4 Mar 2021
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Immune Responses to Topical Imiquimod
- ClinicalTrials.gov ID
- NCT04809662
- Acronym / sponsor ID
- 1646493
- Conditions
- Actinic Keratoses
- Keywords
- imiquimod, aldara
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI failed to submit the study for continuing review to IRB, failed to respond.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 7 Nov 2023 (actual)
- Study completion
- 7 Nov 2023 (actual)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main cohort | – | Drug: ImiquimodThis is a split-body study, with patients acting as their own controls between lesional and nonlesional skin. All patients will apply imiquimod. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will use topical imiquimod as standard of care and who are without immune-mediated systemic disease
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImiquimodAlso: Aldara, ZyclaraPatients 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. | Drug | Main cohort |
Primary outcome
Immune response
Time frame: 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.
3 secondary outcomes
Monitoring
Time frame: 1 year
Flow cytometry
Time frame: 3 years
Immunohistochemistry
Time frame: 3 years
Results and safety
The study was stopped early (reason given: PI failed to submit the study for continuing review to IRB, failed to respond.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Actinic Keratoses, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI failed to submit the study for continuing review to IRB, failed to respond.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune response (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.