Actinic Keratoses
Conditions
Keywords
Actinic keratoses, Dermatologic disease
Brief summary
The objective of this study was to obtain long-term sustained clearance rates for subjects previously treated with imiquimod creams in studies GW01-0702, GW01-0703, GW01-0704 and GW01-0705.
Detailed description
This is a Phase 3 longitudinal and observational study. Subjects who previously enrolled in studies GW01-0702, GW01-0703, GW01-0704, and GW01-0705 and were completely cleared of their AK lesions in the selected treatment area at the end-of-study visit will return for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs. The NCT numbers for the above mentioned studies are: NCT00603798 - for Studies GW01-0703 and GW01-0705 NCT00605176 for Studies GW01-0702 and GW01-0704
Interventions
None listed
Sponsors
Graceway Pharmaceuticals, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Are willing and able to give informed consent; * Have successfully completed one of the following studies: GW01-0702, GW01- 0703, GW01-0704, or GW01-0705 and have been determined to be completely clear of AK lesions at the EOS visit in the designated treatment area from the previous study * Are willing to participate in the study as an outpatient, make visits to the study center for follow-up evaluation, and agree to comply with all study requirements.
Exclusion criteria
* None. All subjects who meet the inclusion criteria above may participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Recurrence of AK Lesions | Up to one year | The primary efficacy variable in this study was the absence of AK lesions(sustained clearance rate) in the previously treated area. |
Participant flow
Recruitment details
This was a Phase 3b longitudinal and observational study.
Pre-assignment details
Subjects previously enrolled in studies GW01-0702, GW01-0703, GW01-0704, or GW01-0705 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study \[EOS\]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
Participants by arm
| Arm | Count |
|---|---|
| 2-Week Treatment Group Subjects who previously enrolled in studies GW01-0702 and GW01-0704 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study \[EOS\]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs. | 89 |
| 3-Week Treatment Group Subjects who previously enrolled in studies GW01-0703 and GW01-0705 and were completely cleared of their actinic keratosis (AK) lesions in the selected treatment area at the 8-week post-treatment (end-of-study \[EOS\]) visit returned for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs. | 90 |
| Total | 179 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 4 |
Baseline characteristics
| Characteristic | 3-Week Treatment Group | 2-Week Treatment Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 40 Participants | 47 Participants | 87 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 42 Participants | 92 Participants |
| Age Continuous | 64.0 years STANDARD_DEVIATION 10.2 | 65.0 years STANDARD_DEVIATION 10.9 | 64.5 years STANDARD_DEVIATION 10.5 |
| Region of Enrollment United States | 90 participants | 89 participants | 179 participants |
| Sex: Female, Male Female | 18 Participants | 25 Participants | 43 Participants |
| Sex: Female, Male Male | 72 Participants | 64 Participants | 136 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 89 | 0 / 90 |
| serious Total, serious adverse events | 0 / 79 | 0 / 90 |
Outcome results
Primary
Number of Participants With Recurrence of AK Lesions
The primary efficacy variable in this study was the absence of AK lesions(sustained clearance rate) in the previously treated area.
Time frame: Up to one year
Population: Efficacy analyses were conducted on the evaluable subject population defined as all subjects who were eligible and enrolled in the follow-up study. All results were summarized overall and by original Phase 3 randomized treatment regimen and dose group. Actinic keratosis recurrence was categorized by presence or absence only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2-Week Treatment Group | Number of Participants With Recurrence of AK Lesions | 52 participants |
| 3-Week Treatment Group | Number of Participants With Recurrence of AK Lesions | 41 participants |