Trial Outcomes & Findings for ACT01 in Combination With Comp01-04 in Patients With Actinic Keratosis (NCT NCT02126670)
NCT ID: NCT02126670
Last Updated: 2016-02-22
Results Overview
Treatment success at end of study visit defined as % of participants with 100% clearance of AK lesions
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
up to Day 57
Results posted on
2016-02-22
Participant Flow
Participant milestones
| Measure |
ACT01 Plus Comp01
ACT01 Cream in combination with Comp01 Cream, once daily, 29 days
ACT01
Comp01
|
ACT01 Plus Comp02
ACT01 Cream in combination with Comp02 Cream, once daily, 29 days
ACT01
Comp02
|
ACT01 Plus Comp03
ACT01 Cream in combination with Comp03 Cream, once daily, 29 days
ACT01
Comp03
|
ACT01 Plus Comp04
ACT01 Cream in combination with Comp04 Cream, once daily, 29 days
ACT01
Comp04
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
26
|
24
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
24
|
25
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
ACT01 Plus Comp01
ACT01 Cream in combination with Comp01 Cream, once daily, 29 days
ACT01
Comp01
|
ACT01 Plus Comp02
ACT01 Cream in combination with Comp02 Cream, once daily, 29 days
ACT01
Comp02
|
ACT01 Plus Comp03
ACT01 Cream in combination with Comp03 Cream, once daily, 29 days
ACT01
Comp03
|
ACT01 Plus Comp04
ACT01 Cream in combination with Comp04 Cream, once daily, 29 days
ACT01
Comp04
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
Baseline Characteristics
ACT01 in Combination With Comp01-04 in Patients With Actinic Keratosis
Baseline characteristics by cohort
| Measure |
ACT01 Plus Comp01
n=25 Participants
ACT01 Cream in combination with Comp01 Cream, once daily, 29 days
ACT01
Comp01
|
ACT01 Plus Comp02
n=24 Participants
ACT01 Cream in combination with Comp02 Cream, once daily, 29 days
ACT01
Comp02
|
ACT01 Plus Comp03
n=25 Participants
ACT01 Cream in combination with Comp03 Cream, once daily, 29 days
ACT01
Comp03
|
ACT01 Plus Comp04
n=24 Participants
ACT01 Cream in combination with Comp04 Cream, once daily, 29 days
ACT01
Comp04
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
64.4 years
STANDARD_DEVIATION 11.08 • n=5 Participants
|
64.4 years
STANDARD_DEVIATION 9.78 • n=7 Participants
|
66.5 years
STANDARD_DEVIATION 8.94 • n=5 Participants
|
66.9 years
STANDARD_DEVIATION 8.28 • n=4 Participants
|
65.5 years
STANDARD_DEVIATION 9.47 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
97 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
97 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
24 participants
n=7 Participants
|
25 participants
n=5 Participants
|
24 participants
n=4 Participants
|
98 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: up to Day 57Population: Per protocol
Treatment success at end of study visit defined as % of participants with 100% clearance of AK lesions
Outcome measures
| Measure |
ACT01 Plus Comp01
n=24 Participants
ACT01 Cream in combination with Comp01 Cream, once daily, 29 days
ACT01
Comp01
|
ACT01 Plus Comp02
n=23 Participants
ACT01 Cream in combination with Comp02 Cream, once daily, 29 days
ACT01
Comp02
|
ACT01 Plus Comp03
n=25 Participants
ACT01 Cream in combination with Comp03 Cream, once daily, 29 days
ACT01
Comp03
|
ACT01 Plus Comp04
n=24 Participants
ACT01 Cream in combination with Comp04 Cream, once daily, 29 days
ACT01
Comp04
|
|---|---|---|---|---|
|
Treatment Success at End of Study Visit
|
66.7 percentage of participants
Interval 47.8 to 85.5
|
65.2 percentage of participants
Interval 45.8 to 84.7
|
76.0 percentage of participants
Interval 59.3 to 92.7
|
66.7 percentage of participants
Interval 47.8 to 85.5
|
SECONDARY outcome
Timeframe: up to Day 57Population: Overall irritation
Percentage of participants with moderate or severe overall irritation at end of treatment.
Outcome measures
| Measure |
ACT01 Plus Comp01
n=25 Participants
ACT01 Cream in combination with Comp01 Cream, once daily, 29 days
ACT01
Comp01
|
ACT01 Plus Comp02
n=24 Participants
ACT01 Cream in combination with Comp02 Cream, once daily, 29 days
ACT01
Comp02
|
ACT01 Plus Comp03
n=25 Participants
ACT01 Cream in combination with Comp03 Cream, once daily, 29 days
ACT01
Comp03
|
ACT01 Plus Comp04
n=24 Participants
ACT01 Cream in combination with Comp04 Cream, once daily, 29 days
ACT01
Comp04
|
|---|---|---|---|---|
|
Irritation Score
|
56.0 percentage of participants
|
75.0 percentage of participants
|
52.0 percentage of participants
|
66.7 percentage of participants
|
Adverse Events
ACT01 Plus Comp01
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
ACT01 Plus Comp02
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
ACT01 Plus Comp03
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
ACT01 Plus Comp04
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ACT01 Plus Comp01
n=26 participants at risk
ACT01 Cream in combination with Comp01 Cream, once daily, 29 days
ACT01
Comp01
|
ACT01 Plus Comp02
n=24 participants at risk
ACT01 Cream in combination with Comp02 Cream, once daily, 29 days
ACT01
Comp02
|
ACT01 Plus Comp03
n=25 participants at risk
ACT01 Cream in combination with Comp03 Cream, once daily, 29 days
ACT01
Comp03
|
ACT01 Plus Comp04
n=25 participants at risk
ACT01 Cream in combination with Comp04 Cream, once daily, 29 days
ACT01
Comp04
|
|---|---|---|---|---|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.00%
0/26
|
0.00%
0/24
|
0.00%
0/25
|
4.0%
1/25 • Number of events 1
|
Other adverse events
| Measure |
ACT01 Plus Comp01
n=26 participants at risk
ACT01 Cream in combination with Comp01 Cream, once daily, 29 days
ACT01
Comp01
|
ACT01 Plus Comp02
n=24 participants at risk
ACT01 Cream in combination with Comp02 Cream, once daily, 29 days
ACT01
Comp02
|
ACT01 Plus Comp03
n=25 participants at risk
ACT01 Cream in combination with Comp03 Cream, once daily, 29 days
ACT01
Comp03
|
ACT01 Plus Comp04
n=25 participants at risk
ACT01 Cream in combination with Comp04 Cream, once daily, 29 days
ACT01
Comp04
|
|---|---|---|---|---|
|
General disorders
Application Site Irritation
|
84.6%
22/26 • Number of events 22
|
100.0%
24/24 • Number of events 24
|
80.0%
20/25 • Number of events 20
|
96.0%
24/25 • Number of events 24
|
|
Nervous system disorders
Headache
|
3.8%
1/26 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
0.00%
0/25
|
0.00%
0/25
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place