Actinic KeratosesPhase 4NCT04842422
Earliest Stage Treatment of Aktinic Keratosis With Imiquimod 3.75% Cream
A Phase 4 study testing Imiquimod 3.75% Cream in people with Actinic Keratoses, run by Medical University of Graz at 1 site in Austria.
Trial summary
Earliest Stage Treatment of Actinic Keratosis with Imiquimod 3.75% Cream: The study is to demonstrate that Aktinic Keratosis are present before they are clinically visible, i.e. in a subclinical stage. Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Actinic Keratoses
- What is being tested?
- Imiquimod 3.75% Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteAustria
- Study dates
- 16 Apr 2021to 23 Aug 2021
- Phase
- Phase 4
- 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 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female supposed-healthy volunteer outpatients, age: > 50 years.
- Diagnosis: patients with chronically UV-exposed photodamaged facial skin.
- Consent by signing the ICF (Informed Consent Form)
Who cannot join
- Current participation in another clinical trial
- Patients who are using topical glucocorticoids on the face.
- Known intolerance/hypersensitivity to imiquimod
- Pregnant/breastfeeding women
- Systemic disease, immunodeficiency
Trial locations and contacts
1 site in 1 country.
About this study
Earliest Stage Treatment of Actinic Keratosis with Imiquimod 3.75% Cream:
The study is to demonstrate that Aktinic Keratosis are present before they are clinically visible, i.e. in a subclinical stage. Since on the basis of the research situation, also subclinical AK can proliferate into the dermis, it is possible that with the application of Imiquimod on chronically light-exposed skin, undetected squamous cell carcinoma can be recognized and treated at the same time.
- Conditions
- Actinic Keratoses
- Being tested
- Imiquimod 3.75% Cream
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imiquimod 3.75% CreamDrug
Imiquimod 3.75% Cream
| Study group | Role | What they receive |
|---|---|---|
| Earliest Stage Treatment of Aktinic Keratosis | Experimental | Not described Receives: Drug: Imiquimod 3.75% Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
immunomodulatory-induced inflammatory reaction
Percentage of subjects in whom an immunomodulatory-induced inflammatory reaction occurs on chronically light-exposed uv-damaged facial skin after two weeks.
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start16 Apr 2021
- Primary completion23 Aug 2021
- Study completion23 Aug 2021
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.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842422
- Sponsor's protocol ID
- 12020
- Status last verified
- Jan 2022
- First submitted
- 8 Apr 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Earliest Stage Treatment of Aktinic Keratosis With Imiquimod 3.75% Cream
- ClinicalTrials.gov ID
- NCT04842422
- Acronym / sponsor ID
- 12020
- Conditions
- Actinic Keratoses
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- 23 Aug 2021 (actual)
- Study completion
- 23 Aug 2021 (actual)
- First posted
- 13 Apr 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.
Earliest Stage Treatment of Actinic Keratosis with Imiquimod 3.75% Cream:
The study is to demonstrate that Aktinic Keratosis are present before they are clinically visible, i.e. in a subclinical stage. Since on the basis of the research situation, also subclinical AK can proliferate into the dermis, it is possible that with the application of Imiquimod on chronically light-exposed skin, undetected squamous cell carcinoma can be recognized and treated at the same time.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Earliest Stage Treatment of Aktinic Keratosis | Experimental | Drug: Imiquimod 3.75% Cream |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female supposed-healthy volunteer outpatients, age: > 50 years.
- Diagnosis: patients with chronically UV-exposed photodamaged facial skin.
- Consent by signing the ICF (Informed Consent Form)
Key exclusion criteria (5 listed)
- Current participation in another clinical trial
- Patients who are using topical glucocorticoids on the face.
- Known intolerance/hypersensitivity to imiquimod
- Pregnant/breastfeeding women
- Systemic disease, immunodeficiency
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 |
|---|---|---|
| Imiquimod 3.75% CreamImiquimod 3.75% Cream | Drug | Earliest Stage Treatment of Aktinic Keratosis |
Primary outcome
immunomodulatory-induced inflammatory reaction
Time frame: two weeks
Percentage of subjects in whom an immunomodulatory-induced inflammatory reaction occurs on chronically light-exposed uv-damaged facial skin after two weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
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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?
A Phase 4 study testing Imiquimod 3.75% Cream in people with Actinic Keratoses, run by Medical University of Graz at 1 site in Austria.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 11 Jan 2022. 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 Austria. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
immunomodulatory-induced inflammatory reaction (time frame: two weeks). 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 11 Jan 2022.