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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03914417
Recruitment Status : Completed
First Posted : April 16, 2019
Results First Posted : October 20, 2020
Last Update Posted : October 20, 2020
Sponsor:
Collaborator:
Bausch Health Americas, Inc.
Information provided by (Responsible Party):
Sharon Rose, Icahn School of Medicine at Mount Sinai

Brief 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.

Condition or disease Intervention/treatment Phase
Actinic Keratosis Drug: Imiquimod 3.75% Cream Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Application of imiquimod 3.75% cream to treat actinic keratosis
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2013
Actual Primary Completion Date : April 30, 2015
Actual Study Completion Date : April 30, 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Imiquimod

Arm Intervention/treatment
Experimental: Imiquimod 3.75% cream
applied topically
Drug: Imiquimod 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).




Primary Outcome Measures :
  1. 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%.


Secondary Outcome Measures :
  1. Number of Treatment Related Adverse Events [ Time Frame: Day 70 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914417


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Bausch Health Americas, Inc.
Investigators
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Principal Investigator: Sharon Rose, MD Icahn School of Medicine at Mount Sinai
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Responsible Party: Sharon Rose, Resident, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03914417    
Other Study ID Numbers: GCO 13-1215
First Posted: April 16, 2019    Key Record Dates
Results First Posted: October 20, 2020
Last Update Posted: October 20, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sharon Rose, Icahn School of Medicine at Mount Sinai:
Actinic Keratosis
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers