Actinic Keratosis
Conditions
Keywords
Actinic Keratosis
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.
Interventions
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).
Sponsors
Bausch Health Americas, Inc.
Icahn School of Medicine at Mount Sinai
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Application of imiquimod 3.75% cream to treat actinic keratosis
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Responders | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatment Related Adverse Events | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment/Enrollment from Jan 1, 2013 - Jan 1, 2015
Participants by arm
| Arm | Count |
|---|---|
| Imiquimod 3.75% Cream Imiquimod 3.75% Cream topically: 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. | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Imiquimod 3.75% Cream |
|---|---|
| Age, Continuous | 73 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 16 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Imiquimod 3.75% Cream | Number of Responders | 19 Participants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Imiquimod 3.75% Cream | Number of Treatment Related Adverse Events | 8 events |