Actinic KeratosisPhase 2NCT03914417
Genomic Markers Before and After Treatment of Actinic Keratosis With Imiquimod 3.75% Cream
A Phase 2 study testing Imiquimod 3.75% Cream in people with Actinic Keratosis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The study team had plans to treat approximately 30 subjects. Each subject that had qualified had at least 4-8 visible AKs on the face and/or scalp. At Day 0, one Actinic Keratosis (AK) in the treatment area had been biopsied via a 3 mm punch. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- Imiquimod 3.75% Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 30 Apr 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults at least 18 years old.
- Subjects must be in good general health as confirmed by the medical history.
- Subjects must be able to read, sign, and understand the informed consent.
- Prior to imiquimod therapy, subjects must have at least 4-8 actinic keratoses on the face and/or scalp.
- Subject must be willing to forego any other treatments on the face and/or scalp, including tanning bed use and excessive sun exposure while in the study.
- Subject is willing and able to participate in the study as an outpatient, making frequent visits to the study center during the treatment and follow-up periods and to comply with all study requirements including concomitant medication and other treatment restrictions.
- If subject is a female of childbearing potential she must have a negative urine pregnancy test result prior to study treatment initiation and must agree to use an approved method of birth control while enrolled in the study.
Who cannot join
- Subjects with a history of melanoma anywhere on the body.
- Subjects with an unstable medical condition as deemed by the clinical investigator.
- Subjects with non-melanoma skin cancer on the face and/or or scalp.
- Subjects with any dermatologic disease in the treatment area that may be exacerbated by the treatment proposed or that might impair the evaluation of AKs.
- Subjects who have previously been treated with imiquimod: on the face or scalp in the past 6 months; or outside of the study area within the past 30 days.
- Women who are pregnant, lactating, or planning to become pregnant during the study period.
Show all 18Show fewer
- Subjects who have experienced a clinically important medical event within 90 days of the visit (e.g., stroke, myocardial infarction, etc).
- Subjects who have active chemical dependency or alcoholism as assessed by the investigator.
- Subjects who have known allergies to any excipient in the study cream.
- Subjects who are currently participating in another clinical study or have completed another clinical study with an investigational drug or device on the study area within 30 days prior to study treatment initiation.
- Subjects who have received any of the following within 90 days prior to study treatment initiation:
- interferon or interferon inducers
- cytotoxic drugs
- immunomodulators or immunosuppressive therapies (inhaled/ intranasal steroids are permitted)
- oral or parenteral corticosteroids
- topical corticosteroids if greater than 2 mg/day
- any dermatologic procedures or surgeries on the study area (including any AK treatments)
- Subjects who have used any topical prescription medications on the study area within 30 days prior to study treatment initiation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: An Investigator-initiated Study to Evaluate Genomic Markers of Immune Infiltration Before and After Treatment of Actinic Keratosis With Imiquimod 3.75% Cream
The study team had plans to treat approximately 30 subjects. Each subject that had qualified had at least 4-8 visible AKs on the face and/or scalp. At Day 0, one Actinic Keratosis (AK) in the treatment area had been biopsied via a 3 mm punch. The tissue collected was sent to pathology for confirmatory diagnosis as well as genomic analysis. The remaining AKs had been identified, photographed, and documented on a transparency. One of the remaining AKs was designated as the target lesion. The patient returned to the clinic in 7 days (+/- 3) for suture removal. Approximately two weeks after Day 0, the entire treatment area was treated with imiquimod 3.75% cream. Subjects utilized the 2 weeks on, 2 weeks off, 2 weeks on regimen. Subjects were followed every 2 weeks during treatment (week 2, 4 and 6) and then at 4 and 8 weeks post last-imiquimod application (week 10 and 14). At week 14, a biopsy via a 3 mm punch was done of the target lesion. Yet, if the target lesion was no longer present, a biopsy was done at the site where the lesion was previously located.
- Conditions
- Actinic Keratosis
- Being tested
- Imiquimod 3.75% Cream
- Keywords
- Actinic Keratosis
- 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
Approximately two weeks after Day 0, the entire treatment area was treated with imiquimod 3.75% cream. Subjects utilized the 2 weeks on, 2 weeks off, 2 weeks on regimen. Subjects were followed every 2 weeks during treatment (week 2, 4 and 6) and then at 4 and 8 weeks post last-imiquimod application (week 10 and 14).
| Study group | Role | What they receive |
|---|---|---|
| Imiquimod 3.75% cream | Experimental | applied topically Receives: Drug: Imiquimod 3.75% Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Responders
The number of participants with reduction in number of AKs on the face and/or scalp after application of imiquimod 3.75%.
Measured: Day 70
Secondary outcomes (1)
Number of Treatment Related Adverse Events
The safety of imiquimod 3.75% on the face and/or scalp was determined by the number of treatment related adverse events that occur during the study.
Measured: Day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study startJan 2013
- Primary completion30 Apr 2015
- Study completion30 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Application of imiquimod 3.75% cream to treat actinic keratosis
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Responsible party
- Principal investigator, Sharon Rose, Icahn School of Medicine at Mount Sinai
- Investigators
- Sharon Rose, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914417
- Sponsor's protocol ID
- GCO 13-1215
- Status last verified
- Dec 2020
- First submitted
- 3 May 2017
- Last updated
- 20 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-initiated Study to Evaluate Genomic Markers of Immune Infiltration Before and After Treatment of Actinic Keratosis With Imiquimod 3.75% Cream
- ClinicalTrials.gov ID
- NCT03914417
- Acronym / sponsor ID
- GCO 13-1215
- Conditions
- Actinic Keratosis
- Keywords
- Actinic Keratosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Study start
- Jan 2013 (actual)
- Primary completion
- 30 Apr 2015 (actual)
- Study completion
- 30 Apr 2015 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Posted 20 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study team had plans to treat approximately 30 subjects. Each subject that had qualified had at least 4-8 visible AKs on the face and/or scalp. At Day 0, one Actinic Keratosis (AK) in the treatment area had been biopsied via a 3 mm punch. The tissue collected was sent to pathology for confirmatory diagnosis as well as genomic analysis. The remaining AKs had been identified, photographed, and documented on a transparency. One of the remaining AKs was designated as the target lesion. The patient returned to the clinic in 7 days (+/- 3) for suture removal. Approximately two weeks after Day 0, the entire treatment area was treated with imiquimod 3.75% cream. Subjects utilized the 2 weeks on, 2 weeks off, 2 weeks on regimen. Subjects were followed every 2 weeks during treatment (week 2, 4 and 6) and then at 4 and 8 weeks post last-imiquimod application (week 10 and 14). At week 14, a biopsy via a 3 mm punch was done of the target lesion. Yet, if the target lesion was no longer present, a biopsy was done at the site where the lesion was previously located.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Application of imiquimod 3.75% cream to treat actinic keratosis
| Arm | Type | Receives |
|---|---|---|
| Imiquimod 3.75% cream | Experimental | Drug: Imiquimod 3.75% Creamapplied topically |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults at least 18 years old.
- Subjects must be in good general health as confirmed by the medical history.
- Subjects must be able to read, sign, and understand the informed consent.
- Prior to imiquimod therapy, subjects must have at least 4-8 actinic keratoses on the face and/or scalp.
- Subject must be willing to forego any other treatments on the face and/or scalp, including tanning bed use and excessive sun exposure while in the study.
Key exclusion criteria (18 listed)
- Subjects with a history of melanoma anywhere on the body.
- Subjects with an unstable medical condition as deemed by the clinical investigator.
- Subjects with non-melanoma skin cancer on the face and/or or scalp.
- Subjects with any dermatologic disease in the treatment area that may be exacerbated by the treatment proposed or that might impair the evaluation of AKs.
- Subjects who have previously been treated with imiquimod: on the face or scalp in the past 6 months; or outside of the study area within the past 30 days.
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% CreamApproximately two weeks after Day 0, the entire treatment area was treated with imiquimod 3.75% cream. Subjects utilized the 2 weeks on, 2 weeks off, 2 weeks on regimen. Subjects were followed every 2 weeks during treatment (week 2, 4 and 6) and then at 4 and 8 weeks post last-imiquimod application (week 10 and 14). | Drug | Imiquimod 3.75% cream |
Primary outcome
Number of Responders
Time frame: Day 70
The number of participants with reduction in number of AKs on the face and/or scalp after application of imiquimod 3.75%.
1 secondary outcome
Number of Treatment Related Adverse Events
Time frame: Day 70
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Actinic Keratosis
Active, not recruitingPhase 1
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
Netherton Syndrome
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
Actinic Keratosis
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
Actinic Keratosis
Active, not recruitingPhase 3
A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses
Multiple Actinic Keratoses
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma
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.
Sharon Rose, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imiquimod 3.75% Cream in people with Actinic Keratosis, run by Icahn School of Medicine at Mount Sinai 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 7 inclusion and 18 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 20 Jan 2021. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Responders (time frame: Day 70). 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 20 Jan 2021.