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CompletedNCT03914417Updated Jan 20, 2021Results posted

Genomic Markers Before and After Treatment of Actinic Keratosis With Imiquimod 3.75% Cream

A Phase 2 interventional study of Imiquimod 3.75% Cream in Actinic Keratosis, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-20.

Sponsored by Icahn School of Medicine at Mount Sinai · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 4 months after the study started (first participant enrolled Jan 2013, registered May 2017).
Phase
Phase 2
Study type
Interventional
Enrollment
21
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Actinic Keratosis

Keywords

  • Actinic Keratosis
03

In context

Keratosis, Actinic

364 studies on the registry are indexed under Keratosis, Actinic; 31 are open to participants now.

This study's enrollment of 21 is below the median of 60 across 315 interventional studies indexed under Keratosis, Actinic.

Browse Keratosis, Actinic studies →

Lead sponsor

Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.

Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    Imiquimod 3.75% cream

    applied topically

    Drug: Imiquimod 3.75% Cream

Interventions

  • DrugImiquimod 3.75% Cream

    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).

06

What researchers measure

Primary outcomes

  1. 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%.

    Time frame: 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.

    Time frame: Day 70

07

Results

Posted Oct 20, 2020

Participant flow

Recruitment/Enrollment from Jan 1, 2013 - Jan 1, 2015

Participant flow — Overall Study
MilestoneImiquimod 3.75% Cream
Started21
Completed19
Not completed2
Withdrew: Withdrawal by subject2

Outcome measures

PrimaryNumber of Responders

The number of participants with reduction in number of AKs on the face and/or scalp after application of imiquimod 3.75%.

Time frame:
Day 70
Reported as:
Count of participants · Participants
Number of Responders
ParticipantsImiquimod 3.75% Cream
Number of Responders19
SecondaryNumber 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.

Time frame:
Day 70
Reported as:
Number · events
Number of Treatment Related Adverse Events
eventsImiquimod 3.75% Cream
Number of Treatment Related Adverse Events8

Adverse events

Collected over 70 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Imiquimod 3.75% Cream0/19 (0%)0/19 (0%)16/19 (84.2%)
Most frequent other events
Showing 10 of 12
Most frequent other events
EventImiquimod 3.75% Cream
Left Post-auricular lymphadenopathyBlood and lymphatic system disorders2/19
Pruritus on treatment areaSkin and subcutaneous tissue disorders2/19
Flu-like symptomsGeneral disorders2/19
Viral Upper Respiratory InfectionInfections and infestations2/19
Back PainMusculoskeletal and connective tissue disorders1/19
Maculopapular Rash, forearmsSkin and subcutaneous tissue disorders1/19
ArthralgiasMusculoskeletal and connective tissue disorders1/19
Intolerable LSRSkin and subcutaneous tissue disorders1/19
Facial SwellingSkin and subcutaneous tissue disorders1/19
GastroenteritisGastrointestinal disorders1/19

Baseline characteristics

Age, Continuous
Age, Continuous(years)Imiquimod 3.75% Cream
Median73 (65 to 85)
Sex: Female, Male
Sex: Female, Male(Participants)Imiquimod 3.75% Cream
Female1
Male20
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Imiquimod 3.75% Cream
Hispanic or Latino0
Not Hispanic or Latino19
Unknown or Not Reported2
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Imiquimod 3.75% Cream
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White19
More than one race0
Unknown or Not Reported2
08

Study locations

1 site
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10029, United States
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03914417
Lead sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Bausch Health Americas, Inc.
Responsible party
Sharon Rose (Resident, Icahn School of Medicine at Mount Sinai) — Principal investigator
First posted
Apr 16, 2019
Start date
Jan 2013
Primary completion
Apr 30, 2015
Completion
Apr 30, 2015
Results posted
Oct 20, 2020
Last update
Jan 20, 2021

Study contacts

Sharon Rose, MD
principal investigator · Icahn School of Medicine at Mount Sinai

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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