Trial Outcomes & Findings for Follow-up Study to Evaluate Sustained Clearance Rates of Actinic Keratoses up to One Year (NCT NCT00668733)
NCT ID: NCT00668733
Last Updated: 2010-07-20
Results Overview
The primary efficacy variable in this study was the absence of AK lesions(sustained clearance rate) in the previously treated area.
Recruitment status
COMPLETED
Target enrollment
179 participants
Primary outcome timeframe
Up to one year
Results posted on
2010-07-20
Participant Flow
This was a Phase 3b longitudinal and observational study.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
90
|
|
Overall Study
COMPLETED
|
87
|
83
|
|
Overall Study
NOT COMPLETED
|
2
|
7
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
Baseline Characteristics
Follow-up Study to Evaluate Sustained Clearance Rates of Actinic Keratoses up to One Year
Baseline characteristics by cohort
| Measure |
2-Week Treatment Group
n=89 Participants
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.
|
3-Week Treatment Group
n=90 Participants
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.
|
Total
n=179 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
47 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Age Continuous
|
65.0 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
64.0 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
64.5 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
89 participants
n=5 Participants
|
90 participants
n=7 Participants
|
179 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to one yearPopulation: 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.
The primary efficacy variable in this study was the absence of AK lesions(sustained clearance rate) in the previously treated area.
Outcome measures
| Measure |
2-Week Treatment Group
n=89 Participants
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.
|
3-Week Treatment Group
n=90 Participants
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.
|
|---|---|---|
|
Number of Participants With Recurrence of AK Lesions
|
52 participants
|
41 participants
|
Adverse Events
2-Week Treatment Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
3-Week Treatment Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
2-Week Treatment Group
n=89 participants at risk；n=79 participants at risk
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.
|
3-Week Treatment Group
n=90 participants at risk
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.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
3.4%
3/89 • Number of events 3 • 12 months
All AEs that were ongoing or started in the previous treatment area at the end of Phase 3 study, or any AEs that occurred that were related to the previous Phase 3 study medication were recorded.
|
0.00%
0/90 • 12 months
All AEs that were ongoing or started in the previous treatment area at the end of Phase 3 study, or any AEs that occurred that were related to the previous Phase 3 study medication were recorded.
|
Additional Information
Sharon F. Levy, MD / Sr. VP, Clinical Product Development
Graceway Pharmaceuticals
Phone: 267-948-0400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place