Keratosis
Conditions
Keywords
actinic keratosis lesions large head torso extremities, actinic keratosis
Brief summary
Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The purpose of this study is to evaluate the safety of one, two, or three cycles of imiquimod for the treatment of AK. The AK lesions treated can be in adjacent and nonadjacent areas of the head, torso, and extremities. The total surface area for the AK lesions must be greater than 25 cm2. The secondary objective is to evaluate the effectiveness of treatment with imiquimod in people with large surface areas of AK.
Detailed description
This was a Phase 4, open-label, single-arm, multicenter study in male and female subjects aged 18 years or older with clinically diagnosed AK lesions, conducted at 31 investigational sites in the United States. This study assessed the safety of imiquimod as a treatment for AK applied in doses ranging from one packet 12.5 mg) to 6 packets (75 mg) to either single or multiple body regions for up to 3 cycles, depending upon treatment success and AK lesion recurrence. Eligible subjects applied imiquimod 5% cream prior to normal sleeping hours 2 days per week to at least 4 clinically typical, visible, discrete, nonhypertrophic AK lesions in contiguous or noncontiguous treatment areas totaling greater than 25 cm2 at baseline. Multiple treatment areas could be exposed (i.e., head, torso and/or extremities), with the number of packets determined by the investigator but not to exceed one packet for each 25 cm2 treatment area, up to a maximum of 6 packets per dose. In each treatment cycle, dosing was to continue for 16 weeks (approximately 4 months), as instructed by the investigator, followed by a 2-month, treatment-free follow-up period.
Interventions
DRUGimiquimod cream
imiquimod 5% cream applied in doses ranging from one packet (12.5 mg) to 6 packets (75 mg) to either single or multiple body regions for up to 3 cycles
Sponsors
Graceway Pharmaceuticals, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Are at least 18 years of age. * Have greater than 25 cm2 total treatment area(s) containing at least 4 actinic keratosis lesions.
Exclusion criteria
* Have any skin condition in the treatment area that may be made worse by treatment with imiquimod (e.g., rosacea, psoriasis, atopic dermatitis, eczema). * Have received specific treatments/medications in the treatment area(s) within the designated time period prior to study treatment initiation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced an Adverse Event | from first dose up to 18 months | Adverse events that occurred between the first day of exposure to the study cream and study discharge were summarized. Adverse events - any untoward medical occurrence in a subject that is temporally related to protocol procedures, including the administration of a pharmaceutical product at any dose, but which does not necessarily have a causal relationship with the treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Reduction From Baseline to the Final Follow-up in Total Actinic Keratosis Lesion Count | At Month 18 | Percent reduction = (total baseline AK lesion count - total final lesion count)x100/ total baseline AK lesion count |
Countries
United States
Participant flow
Recruitment details
Study start - 14 July 2005 at 31 study centers 500 subjects were planned, with up to 15 subjects enrolled at each study center; however, some study centers were unable to enroll 15 subjects, so active centers were asked to enroll additional subjects.
Pre-assignment details
Open-label study - subjects were required to be at least 18 years of age and to have greater than 25 centimeters squared total treatment area(s) containing at least 4 clinically typical, visible, discrete, nonhypertrophic Actinic Keratosis lesions without any dermatological disease and/or condition in the treatment or surrounding area.
Participants by arm
| Arm | Count |
|---|---|
| Aldara (Imiquimod) Cream Aldara (imiquimod) Cream 5% | 551 |
| Total | 551 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 20 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Local Skin Reaction | 9 |
| Overall Study | Lost to Follow-up | 32 |
| Overall Study | Protocol Specified | 7 |
| Overall Study | Various Reasons | 18 |
| Overall Study | Withdrawal by Subject | 68 |
Baseline characteristics
| Characteristic | Aldara (Imiquimod) Cream |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 344 Participants |
| Age, Categorical Between 18 and 65 years | 207 Participants |
| Age Continuous | 67.5 years STANDARD_DEVIATION 10.71 |
| Baseline actinic keratosis lesion count | 45.5 actinic keratosis lesions STANDARD_DEVIATION 2.36 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 529 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 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 | 0 Participants |
| Race (NIH/OMB) White | 551 Participants |
| Region of Enrollment United States | 551 participants |
| Sex: Female, Male Female | 114 Participants |
| Sex: Female, Male Male | 437 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 472 / 551 |
| serious Total, serious adverse events | 39 / 551 |
Outcome results
Primary
Number of Participants Who Experienced an Adverse Event
Adverse events that occurred between the first day of exposure to the study cream and study discharge were summarized. Adverse events - any untoward medical occurrence in a subject that is temporally related to protocol procedures, including the administration of a pharmaceutical product at any dose, but which does not necessarily have a causal relationship with the treatment.
Time frame: from first dose up to 18 months
Population: There were 551 subjects in the Safety population, which consisted of the enrolled subjects who received at least one dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aldara (Imiquimod) Cream | Number of Participants Who Experienced an Adverse Event | 472 participants |
Secondary
Percent Reduction From Baseline to the Final Follow-up in Total Actinic Keratosis Lesion Count
Percent reduction = (total baseline AK lesion count - total final lesion count)x100/ total baseline AK lesion count
Time frame: At Month 18
Population: The ITT population (n=526) consisted of the Safety population who had at least one scheduled primary efficacy assessment at a post-baseline visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aldara (Imiquimod) Cream | Percent Reduction From Baseline to the Final Follow-up in Total Actinic Keratosis Lesion Count | 80.2 percent reduction | Standard Deviation 1.55 |