Genomic Markers Before and After Treatment of Actinic Keratosis With Imiquimod 3.75% Cream
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Imiquimod 3.75% Cream
Intervention description: 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).
Intervention MeSH terms: Imiquimod
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Application of imiquimod 3.75% cream to treat actinic keratosis
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Actinic Keratosis

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.
    

Eligibility 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.