Trial Outcomes & Findings for Clinical Trial of Ingenol Mebutate Gel 0.015% & 0.05% in Actinic Keratosis (NCT NCT02716714)
NCT ID: NCT02716714
Last Updated: 2018-04-18
Results Overview
Complete Clearance (CC) means that clearance of all visible AK lesions in the selected treatment area and Investigator-rated actinic keratiosis(AK) lesion complete clearance (CC) rate at the selected treatment area on day 57 was analyzed.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
77 participants
Primary outcome timeframe
at day 57
Results posted on
2018-04-18
Participant Flow
This study enrolled patients with actinic keratosis (AK) patients with the lesions on the face, scalp, trunk and/or extremities from 10 academic medical centers in South Korea. First subject was enrolled on 06 Apr 2015 and Last subject was completed on 13 Jun 2016.
Participant milestones
| Measure |
Ingenol Mebutate Gel 0.015%
Participants with actinic keratosis on the face or scalp received 1 tube of ingenol mebutate gel 0.015% to be self-applied to the selected treatment area once daily for 3 consecutive days.
1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area.
|
Ingenol Mebutate Gel 0.05%
Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days.
1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area.
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
10
|
|
Overall Study
COMPLETED
|
55
|
8
|
|
Overall Study
NOT COMPLETED
|
12
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
73 participants of overall number of baseline participants are analyzed as Intention To Treat (ITT) set. Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study and conducted the assessment of the primary efficacy measure.
Baseline characteristics by cohort
| Measure |
Ingenol Mebutate Gel 0.015%
n=64 Participants
Participants with actinic keratosis on the face or scalp received 1 tube of ingenol mebutate gel 0.015% to be self-applied to the selected treatment area once daily for 3 consecutive days.
1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area.
|
Ingenol Mebutate Gel 0.05%
n=9 Participants
Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days.
1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area.
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.39 years
STANDARD_DEVIATION 8.85 • n=5 Participants • 73 participants of overall number of baseline participants are analyzed as Intention To Treat (ITT) set. Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study and conducted the assessment of the primary efficacy measure.
|
72.11 years
STANDARD_DEVIATION 5.44 • n=7 Participants • 73 participants of overall number of baseline participants are analyzed as Intention To Treat (ITT) set. Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study and conducted the assessment of the primary efficacy measure.
|
72.36 years
STANDARD_DEVIATION 8.47 • n=5 Participants • 73 participants of overall number of baseline participants are analyzed as Intention To Treat (ITT) set. Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study and conducted the assessment of the primary efficacy measure.
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants • 73 participants of overall number of baseline participants are analyzed as Intention To Treat (ITT) set. Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study and conducted the assessment of the primary efficacy measure.
|
4 Participants
n=7 Participants • 73 participants of overall number of baseline participants are analyzed as Intention To Treat (ITT) set. Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study and conducted the assessment of the primary efficacy measure.
|
50 Participants
n=5 Participants • 73 participants of overall number of baseline participants are analyzed as Intention To Treat (ITT) set. Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study and conducted the assessment of the primary efficacy measure.
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants • 73 participants of overall number of baseline participants are analyzed as Intention To Treat (ITT) set. Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study and conducted the assessment of the primary efficacy measure.
|
5 Participants
n=7 Participants • 73 participants of overall number of baseline participants are analyzed as Intention To Treat (ITT) set. Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study and conducted the assessment of the primary efficacy measure.
|
23 Participants
n=5 Participants • 73 participants of overall number of baseline participants are analyzed as Intention To Treat (ITT) set. Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study and conducted the assessment of the primary efficacy measure.
|
|
Fitzpatrick skin type
I
|
0 Participants
n=5 Participants • Intent to treat population(Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study).
|
0 Participants
n=7 Participants • Intent to treat population(Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study).
|
0 Participants
n=5 Participants • Intent to treat population(Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study).
|
|
Fitzpatrick skin type
II
|
7 Participants
n=5 Participants • Intent to treat population(Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study).
|
1 Participants
n=7 Participants • Intent to treat population(Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study).
|
8 Participants
n=5 Participants • Intent to treat population(Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study).
|
|
Fitzpatrick skin type
III
|
42 Participants
n=5 Participants • Intent to treat population(Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study).
|
6 Participants
n=7 Participants • Intent to treat population(Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study).
|
48 Participants
n=5 Participants • Intent to treat population(Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study).
|
|
Fitzpatrick skin type
IV
|
15 Participants
n=5 Participants • Intent to treat population(Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study).
|
2 Participants
n=7 Participants • Intent to treat population(Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study).
|
17 Participants
n=5 Participants • Intent to treat population(Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study).
|
|
Fitzpatrick skin type
V
|
0 Participants
n=5 Participants • Intent to treat population(Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study).
|
0 Participants
n=7 Participants • Intent to treat population(Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study).
|
0 Participants
n=5 Participants • Intent to treat population(Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study).
|
|
Fitzpatrick skin type
VI
|
0 Participants
n=5 Participants • Intent to treat population(Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study).
|
0 Participants
n=7 Participants • Intent to treat population(Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study).
|
0 Participants
n=5 Participants • Intent to treat population(Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study).
|
|
Height
|
157.64 cm
STANDARD_DEVIATION 7.72 • n=5 Participants • Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).
|
159.89 cm
STANDARD_DEVIATION 5.75 • n=7 Participants • Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).
|
157.92 cm
STANDARD_DEVIATION 7.51 • n=5 Participants • Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).
|
|
Weight
|
56.42 kg
STANDARD_DEVIATION 8.89 • n=5 Participants • Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).
|
60.24 kg
STANDARD_DEVIATION 8.98 • n=7 Participants • Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).
|
56.89 kg
STANDARD_DEVIATION 8.93 • n=5 Participants • Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).
|
|
BMI
|
22.62 kg/m^2
STANDARD_DEVIATION 2.59 • n=5 Participants • Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).
|
23.49 kg/m^2
STANDARD_DEVIATION 2.63 • n=7 Participants • Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).
|
22.73 kg/m^2
STANDARD_DEVIATION 2.60 • n=5 Participants • Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).
|
|
Actinic keratosis duration
|
8.43 months
STANDARD_DEVIATION 26.73 • n=5 Participants • Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).
|
19.10 months
STANDARD_DEVIATION 52.48 • n=7 Participants • Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).
|
9.74 months
STANDARD_DEVIATION 30.72 • n=5 Participants • Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).
|
|
Actinic keratosis duration at the selected treatment area
|
2.03 months
STANDARD_DEVIATION 8.67 • n=5 Participants • Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).
|
1.03 months
STANDARD_DEVIATION 1.78 • n=7 Participants • Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).
|
1.91 months
STANDARD_DEVIATION 8.14 • n=5 Participants • Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).
|
|
Severity of actinic keratosis
AK I (Mild)
|
9 Participants
n=5 Participants • Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).
|
3 Participants
n=7 Participants • Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).
|
12 Participants
n=5 Participants • Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).
|
|
Severity of actinic keratosis
AK II (Moderate)
|
42 Participants
n=5 Participants • Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).
|
5 Participants
n=7 Participants • Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).
|
47 Participants
n=5 Participants • Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).
|
|
Severity of actinic keratosis
AK III (Severe)
|
13 Participants
n=5 Participants • Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).
|
1 Participants
n=7 Participants • Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).
|
14 Participants
n=5 Participants • Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).
|
|
Prior treatment history of actinic keratosis
Yes
|
12 Participants
n=5 Participants • Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).
|
3 Participants
n=7 Participants • Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).
|
15 Participants
n=5 Participants • Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).
|
|
Prior treatment history of actinic keratosis
No
|
52 Participants
n=5 Participants • Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).
|
6 Participants
n=7 Participants • Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).
|
58 Participants
n=5 Participants • Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).
|
PRIMARY outcome
Timeframe: at day 57Population: Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).
Complete Clearance (CC) means that clearance of all visible AK lesions in the selected treatment area and Investigator-rated actinic keratiosis(AK) lesion complete clearance (CC) rate at the selected treatment area on day 57 was analyzed.
Outcome measures
| Measure |
Ingenol Mebutate Gel 0.015%
n=64 Participants
Participants with actinic keratosis on the face or scalp received 1 tube of ingenol mebutate gel 0.015% to be self-applied to the selected treatment area once daily for 3 consecutive days.
1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area.
|
Ingenol Mebutate Gel 0.05%
n=9 Participants
Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days.
1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area.
|
|---|---|---|
|
CC Rate of AK Lesions in the Selected Treatment Area
CC
|
49 Participants
|
8 Participants
|
|
CC Rate of AK Lesions in the Selected Treatment Area
Non-CC
|
15 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and Day 57Population: Intent to treat population(Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study).
Percentage change from baseline in the number of actinic keratiosis(AK) lesions in the selected treatment area on Day 57 was analyzed.
Outcome measures
| Measure |
Ingenol Mebutate Gel 0.015%
n=64 Participants
Participants with actinic keratosis on the face or scalp received 1 tube of ingenol mebutate gel 0.015% to be self-applied to the selected treatment area once daily for 3 consecutive days.
1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area.
|
Ingenol Mebutate Gel 0.05%
n=9 Participants
Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days.
1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area.
|
|---|---|---|
|
Percentage Change of the Number of AK Lesions in the Selected Treatment Area
|
-80.08 percentage change
Standard Deviation 38.36
|
-88.89 percentage change
Standard Deviation 33.33
|
SECONDARY outcome
Timeframe: at 6 monthsPopulation: In intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study), CC Group consisted of 54 participants who had at least 1 follow-up after achieving complete clearance of AK lesions on Day 57.
Sustained Complete Clearance means that Complete Clearance was maintained until Month 6 in complete clearance (CC) group and sustained complete clearance(CC) rate at month 6 for complete clearance(CC) group was analyzed.
Outcome measures
| Measure |
Ingenol Mebutate Gel 0.015%
n=47 Participants
Participants with actinic keratosis on the face or scalp received 1 tube of ingenol mebutate gel 0.015% to be self-applied to the selected treatment area once daily for 3 consecutive days.
1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area.
|
Ingenol Mebutate Gel 0.05%
n=7 Participants
Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days.
1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area.
|
|---|---|---|
|
Sustained CC Rate in CC Group
Sustained CC
|
42 Participants
|
6 Participants
|
|
Sustained CC Rate in CC Group
Recurrence
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: at 6 monthsPopulation: In intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study), CC Group consisted of 54 participants who had at least 1 follow-up after achieving complete clearance of AK lesions on Day 57.
Recurrence rate in complete clearance(CC) group was analyzed.
Outcome measures
| Measure |
Ingenol Mebutate Gel 0.015%
n=47 Participants
Participants with actinic keratosis on the face or scalp received 1 tube of ingenol mebutate gel 0.015% to be self-applied to the selected treatment area once daily for 3 consecutive days.
1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area.
|
Ingenol Mebutate Gel 0.05%
n=7 Participants
Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days.
1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area.
|
|---|---|---|
|
Recurrence Rate in CC Group
Recurrence rate
|
5 Participants
|
2 Participants
|
|
Recurrence Rate in CC Group
Censored
|
42 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: at 6 months from baselinePopulation: In intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study), CC Group consisted of 54 participants who had at least 1 follow-up after achieving complete clearance of AK lesions on day 57.
Percentage change from baseline in the number of actinic keratiosis(AK) lesions at Month 6 in the selected treatment area in complete clearance(CC) Group was analyzed.
Outcome measures
| Measure |
Ingenol Mebutate Gel 0.015%
n=47 Participants
Participants with actinic keratosis on the face or scalp received 1 tube of ingenol mebutate gel 0.015% to be self-applied to the selected treatment area once daily for 3 consecutive days.
1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area.
|
Ingenol Mebutate Gel 0.05%
n=7 Participants
Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days.
1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area.
|
|---|---|---|
|
Percentage Change of the Number of AK Lesions in the Selected Treatment Area of CC Group
|
-88.65 Percentage change
Standard Deviation 37.61
|
-85.71 Percentage change
Standard Deviation 37.80
|
SECONDARY outcome
Timeframe: at 29 and 57 days from baselinePopulation: Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).
Skindex-29 is a self-administered QoL questionnaire comprised of 29 items scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 items), symptomatic (7 items), and functional (12 items), with domain scores ranging from 0 to 40, 28, and 48, respectively. Lower scores for each of the domains represents a better Quality of life.
Outcome measures
| Measure |
Ingenol Mebutate Gel 0.015%
n=64 Participants
Participants with actinic keratosis on the face or scalp received 1 tube of ingenol mebutate gel 0.015% to be self-applied to the selected treatment area once daily for 3 consecutive days.
1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area.
|
Ingenol Mebutate Gel 0.05%
n=9 Participants
Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days.
1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area.
|
|---|---|---|
|
Change From Baseline in Quality of Life (Skindex-29)
Functioning(Day 29-Baseline)
|
8.02 units on a scale
Standard Deviation 21.32
|
-7.87 units on a scale
Standard Deviation 14.08
|
|
Change From Baseline in Quality of Life (Skindex-29)
Emotions(Baseline)
|
20.57 units on a scale
Standard Deviation 20.62
|
27.22 units on a scale
Standard Deviation 19.94
|
|
Change From Baseline in Quality of Life (Skindex-29)
Emotions(Day 29)
|
21.21 units on a scale
Standard Deviation 20.24
|
12.50 units on a scale
Standard Deviation 11.59
|
|
Change From Baseline in Quality of Life (Skindex-29)
Emotions(Day 57)
|
15.28 units on a scale
Standard Deviation 19.18
|
12.78 units on a scale
Standard Deviation 16.56
|
|
Change From Baseline in Quality of Life (Skindex-29)
Emotions(Day 29-Baseline)
|
-0.42 units on a scale
Standard Deviation 21.96
|
-14.72 units on a scale
Standard Deviation 20.17
|
|
Change From Baseline in Quality of Life (Skindex-29)
Emotions(Day 57-Baseline)
|
-6.46 units on a scale
Standard Deviation 18.62
|
-14.44 units on a scale
Standard Deviation 20.49
|
|
Change From Baseline in Quality of Life (Skindex-29)
Symptoms(Baseline)
|
16.45 units on a scale
Standard Deviation 17.54
|
31.35 units on a scale
Standard Deviation 18.45
|
|
Change From Baseline in Quality of Life (Skindex-29)
Symptoms(Day 29)
|
20.16 units on a scale
Standard Deviation 17.52
|
13.89 units on a scale
Standard Deviation 8.83
|
|
Change From Baseline in Quality of Life (Skindex-29)
Symptoms(Day 57)
|
12.41 units on a scale
Standard Deviation 14.86
|
12.70 units on a scale
Standard Deviation 14.19
|
|
Change From Baseline in Quality of Life (Skindex-29)
Symptoms(Day 29-Baseline)
|
3.09 units on a scale
Standard Deviation 22.15
|
-17.46 units on a scale
Standard Deviation 17.08
|
|
Change From Baseline in Quality of Life (Skindex-29)
Symptoms(Day 57-Baseline)
|
-4.76 units on a scale
Standard Deviation 19.71
|
-18.65 units on a scale
Standard Deviation 19.62
|
|
Change From Baseline in Quality of Life (Skindex-29)
Functioning(Baseline)
|
8.54 units on a scale
Standard Deviation 13.64
|
13.43 units on a scale
Standard Deviation 11.13
|
|
Change From Baseline in Quality of Life (Skindex-29)
Functioning(Day 29)
|
17.10 units on a scale
Standard Deviation 20.19
|
5.56 units on a scale
Standard Deviation 7.29
|
|
Change From Baseline in Quality of Life (Skindex-29)
Functioning(Day 57)
|
10.58 units on a scale
Standard Deviation 16.97
|
3.24 units on a scale
Standard Deviation 7.52
|
|
Change From Baseline in Quality of Life (Skindex-29)
Functioning(Day 57-Baseline)
|
1.45 units on a scale
Standard Deviation 15.60
|
-10.19 units on a scale
Standard Deviation 14.67
|
SECONDARY outcome
Timeframe: at 29 and 57 days from baselinePopulation: Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).
Participants personally completed the tool to evaluate satisfaction with drug treatment. It consisted of 4 areas of Effectiveness, side effect, convenience, and global satisfaction, with a total of 14 sub-items. The full mark is 100, and it is divided in four stages as follows. * Very good: 76 -100 score * Good: 51-75 score * Not bad: 26-50 score * Bad: 0-25 score Scores for each area ranged from 0 to 100, with higher scores indicating that fewer side effects had occurred and greater treatment satisfaction.
Outcome measures
| Measure |
Ingenol Mebutate Gel 0.015%
n=64 Participants
Participants with actinic keratosis on the face or scalp received 1 tube of ingenol mebutate gel 0.015% to be self-applied to the selected treatment area once daily for 3 consecutive days.
1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area.
|
Ingenol Mebutate Gel 0.05%
n=9 Participants
Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days.
1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area.
|
|---|---|---|
|
Treatment Satisfaction Questionnaire for Medication (TSQM)
Effectiveness(Day 29)
|
57.62 units on a scale
Standard Deviation 18.88
|
61.11 units on a scale
Standard Deviation 11.79
|
|
Treatment Satisfaction Questionnaire for Medication (TSQM)
Effectiveness(Day 57)
|
62.67 units on a scale
Standard Deviation 16.22
|
70.37 units on a scale
Standard Deviation 14.70
|
|
Treatment Satisfaction Questionnaire for Medication (TSQM)
Side-effect(Day 29)
|
84.48 units on a scale
Standard Deviation 22.40
|
91.67 units on a scale
Standard Deviation 14.99
|
|
Treatment Satisfaction Questionnaire for Medication (TSQM)
Side-effect(Day 57)
|
89.26 units on a scale
Standard Deviation 19.84
|
91.41 units on a scale
Standard Deviation 21.89
|
|
Treatment Satisfaction Questionnaire for Medication (TSQM)
Convenience(Day 29)
|
60.75 units on a scale
Standard Deviation 17.38
|
61.11 units on a scale
Standard Deviation 15.96
|
|
Treatment Satisfaction Questionnaire for Medication (TSQM)
Convenience(Day 57)
|
65.10 units on a scale
Standard Deviation 15.85
|
65.43 units on a scale
Standard Deviation 16.62
|
|
Treatment Satisfaction Questionnaire for Medication (TSQM)
Global satisfaction(Day 29)
|
59.22 units on a scale
Standard Deviation 18.89
|
65.08 units on a scale
Standard Deviation 14.48
|
|
Treatment Satisfaction Questionnaire for Medication (TSQM)
Global satisfaction(Day 57)
|
60.60 units on a scale
Standard Deviation 18.27
|
63.49 units on a scale
Standard Deviation 21.26
|
SECONDARY outcome
Timeframe: at 29 and 57 days from baselinePopulation: Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).
The investigator rated the subject's Cosmetic Outcomes Assessment(COA) using 5 grades (Very good, Good, No change, Bad, Very bad), and results were as follows.
Outcome measures
| Measure |
Ingenol Mebutate Gel 0.015%
n=64 Participants
Participants with actinic keratosis on the face or scalp received 1 tube of ingenol mebutate gel 0.015% to be self-applied to the selected treatment area once daily for 3 consecutive days.
1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area.
|
Ingenol Mebutate Gel 0.05%
n=9 Participants
Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days.
1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area.
|
|---|---|---|
|
Cosmetic Outcomes Assessment (COA)
Day 29 · Very good
|
16 Participants
|
3 Participants
|
|
Cosmetic Outcomes Assessment (COA)
Day 29 · Good
|
33 Participants
|
4 Participants
|
|
Cosmetic Outcomes Assessment (COA)
Day 29 · No change
|
5 Participants
|
1 Participants
|
|
Cosmetic Outcomes Assessment (COA)
Day 29 · Bad
|
8 Participants
|
1 Participants
|
|
Cosmetic Outcomes Assessment (COA)
Day 29 · Very bad
|
0 Participants
|
0 Participants
|
|
Cosmetic Outcomes Assessment (COA)
Day 57 · Very good
|
17 Participants
|
4 Participants
|
|
Cosmetic Outcomes Assessment (COA)
Day 57 · Good
|
39 Participants
|
5 Participants
|
|
Cosmetic Outcomes Assessment (COA)
Day 57 · No change
|
6 Participants
|
0 Participants
|
|
Cosmetic Outcomes Assessment (COA)
Day 57 · Bad
|
2 Participants
|
0 Participants
|
|
Cosmetic Outcomes Assessment (COA)
Day 57 · Very bad
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at 6 monthsPopulation: CC Group consisted of 54 participants who had at least 1 follow-up after achieving Complete Clearance of AK lesions on Day 57.
Time to relapse in complete clearance(CC) Group was analyzed. Median survival time with 95% confidence interval was calculated by Kaplan-Meier method.
Outcome measures
| Measure |
Ingenol Mebutate Gel 0.015%
n=47 Participants
Participants with actinic keratosis on the face or scalp received 1 tube of ingenol mebutate gel 0.015% to be self-applied to the selected treatment area once daily for 3 consecutive days.
1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area.
|
Ingenol Mebutate Gel 0.05%
n=7 Participants
Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days.
1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area.
|
|---|---|---|
|
Time to Relapse in CC Group
|
NA days
Interval 144.0 to
It wasn't calculated due to a low Recurrence rate (95% Confidence Interval: \[144.00, NA\]).
|
203 days
Interval 129.0 to 203.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: from 57 days to 6 monthsPopulation: The number of participants who had at least 1 follow-up after assessment of treatment response on Day 57 was 67 and which is consisit of CC group(54 participants) and Non-CC group(13 participants). The CC group and Non-CC group for Ingenol Mebutate Gel 0.015% and 0.05% were intended to be analyzed together.
The count of participants in complete clearance(CC) group and Non-CC group who administered medication for actinic keratosis on the selected treatment area after Day 57 was collected.
Outcome measures
| Measure |
Ingenol Mebutate Gel 0.015%
n=54 Participants
Participants with actinic keratosis on the face or scalp received 1 tube of ingenol mebutate gel 0.015% to be self-applied to the selected treatment area once daily for 3 consecutive days.
1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area.
|
Ingenol Mebutate Gel 0.05%
n=13 Participants
Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days.
1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area.
|
|---|---|---|
|
Medication for Actinic Keratosis
Fluorouracil
|
0 Participants
|
1 Participants
|
|
Medication for Actinic Keratosis
Imiquimod
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: from 57 days to 6 monthsPopulation: The number of participants who had at least 1 follow-up after assessment of treatment response on Day 57 and which is consisit of CC group(54 participants) and Non-CC group(13 participants). The CC group /Non-CC group for Ingenol Mebutate Gel 0.015% and 0.05% were intended to be analyzed together.
The count of participants in complete clearance(CC) group and Non-CC group who received non-drug treatment/surgery for actinic keratosis on the selected treatment area after Day 57 was collected.
Outcome measures
| Measure |
Ingenol Mebutate Gel 0.015%
n=54 Participants
Participants with actinic keratosis on the face or scalp received 1 tube of ingenol mebutate gel 0.015% to be self-applied to the selected treatment area once daily for 3 consecutive days.
1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area.
|
Ingenol Mebutate Gel 0.05%
n=13 Participants
Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days.
1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area.
|
|---|---|---|
|
Non-Drug Treatment/Surgery for Actinic Keratosis
Photodynamic therapy
|
0 Participants
|
1 Participants
|
|
Non-Drug Treatment/Surgery for Actinic Keratosis
Skin cryotherapy
|
5 Participants
|
4 Participants
|
|
Non-Drug Treatment/Surgery for Actinic Keratosis
Phototherapy
|
0 Participants
|
1 Participants
|
|
Non-Drug Treatment/Surgery for Actinic Keratosis
Skin lesion excision
|
1 Participants
|
0 Participants
|
|
Non-Drug Treatment/Surgery for Actinic Keratosis
Wound treatment
|
1 Participants
|
0 Participants
|
|
Non-Drug Treatment/Surgery for Actinic Keratosis
Biopsy skin
|
0 Participants
|
1 Participants
|
Adverse Events
Ingenol Mebutate Gel 0.015%
Serious events: 1 serious events
Other events: 67 other events
Deaths: 0 deaths
Ingenol Mebutate Gel 0.05%
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ingenol Mebutate Gel 0.015%
n=67 participants at risk
Participants with actinic keratosis on the face or scalp received 1 tube of ingenol mebutate gel 0.015% to be self-applied to the selected treatment area once daily for 3 consecutive days.
1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area.
|
Ingenol Mebutate Gel 0.05%
n=10 participants at risk
Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days.
1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Squamous cell carcinoma
|
1.5%
1/67 • Number of events 1
|
0.00%
0/10
|
Other adverse events
| Measure |
Ingenol Mebutate Gel 0.015%
n=67 participants at risk
Participants with actinic keratosis on the face or scalp received 1 tube of ingenol mebutate gel 0.015% to be self-applied to the selected treatment area once daily for 3 consecutive days.
1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area.
|
Ingenol Mebutate Gel 0.05%
n=10 participants at risk
Participants with actinic keratosis on the trunk or extremities received 1 tube of ingenol mebutate gel 0.05% to be self-applied to the selected treatment area once daily for 2 consecutive days.
1 tube (0.47g) contained the amount that can be applied to the area of approximately 25cm2(eg. cn. 5cm X 5cm) and 1 tube was applied to the selected treatment area.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Erythema
|
97.0%
65/67
|
90.0%
9/10
|
|
Skin and subcutaneous tissue disorders
Scab
|
92.5%
62/67
|
80.0%
8/10
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
92.5%
62/67
|
60.0%
6/10
|
|
Skin and subcutaneous tissue disorders
Blister
|
82.1%
55/67
|
70.0%
7/10
|
|
Skin and subcutaneous tissue disorders
Skin swelling
|
76.1%
51/67
|
50.0%
5/10
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
73.1%
49/67
|
40.0%
4/10
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
9.0%
6/67
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.0%
2/67
|
10.0%
1/10
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.5%
1/67
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.5%
1/67
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
1.5%
1/67
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Papule
|
1.5%
1/67
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
1.5%
1/67
|
0.00%
0/10
|
|
General disorders
Administration site pain
|
16.4%
11/67
|
30.0%
3/10
|
|
General disorders
Swelling
|
1.5%
1/67
|
20.0%
2/10
|
|
Infections and infestations
Rash pustular
|
10.4%
7/67
|
0.00%
0/10
|
|
Infections and infestations
Upper respiratory tract infection
|
3.0%
2/67
|
0.00%
0/10
|
|
Infections and infestations
Folliculitis
|
1.5%
1/67
|
0.00%
0/10
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/67
|
10.0%
1/10
|
|
Infections and infestations
Nasopharyngitis
|
1.5%
1/67
|
0.00%
0/10
|
|
Infections and infestations
Tinea pedis
|
1.5%
1/67
|
0.00%
0/10
|
|
Congenital, familial and genetic disorders
Ichthyosis
|
0.00%
0/67
|
10.0%
1/10
|
|
Injury, poisoning and procedural complications
Wound secretion
|
1.5%
1/67
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.5%
1/67
|
0.00%
0/10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place