Trial Outcomes & Findings for A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations (NCT NCT00942604)
NCT ID: NCT00942604
Last Updated: 2015-03-06
Results Overview
Proportion of Patients with Complete Clearance of the treatment field defined as no clinically visible Actinic Keratoses (AK) lesions in the selected treatment area
COMPLETED
PHASE3
203 participants
57 days
2015-03-06
Participant Flow
The study period was 22 July 2009 (first patient randomized) to 14 October 2009 (last patient completed Day 57).
Participant milestones
| Measure |
PEP005 (Ingenol Mebutate) Gel
PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
|
Vehicle Gel
Vehicle gel once daily for 2 consecutive days
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
103
|
|
Overall Study
COMPLETED
|
98
|
99
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
PEP005 (Ingenol Mebutate) Gel
PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
|
Vehicle Gel
Vehicle gel once daily for 2 consecutive days
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Patient relocation
|
1
|
1
|
Baseline Characteristics
A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations
Baseline characteristics by cohort
| Measure |
PEP005 (Ingenol Mebutate) Gel
n=100 Participants
PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
|
Vehicle Gel
n=103 Participants
Vehicle gel once daily for 2 consecutive days
|
Total
n=203 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
|
48 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
52 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=5 Participants
|
103 participants
n=7 Participants
|
203 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 57 daysPopulation: Intention to treat population
Proportion of Patients with Complete Clearance of the treatment field defined as no clinically visible Actinic Keratoses (AK) lesions in the selected treatment area
Outcome measures
| Measure |
PEP005 (Ingenol Mebutate) Gel
n=100 Participants
PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
|
Vehicle Gel
n=103 Participants
Vehicle gel once daily for 2 consecutive days
|
|---|---|---|
|
Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions
|
42 participants
|
5 participants
|
SECONDARY outcome
Timeframe: 57 daysPopulation: Intention to treat population
Proportion of patients with Partial Clearance defined as ≥ 75 % reduction in the number of Actinic Keratoses (AK) lesions identified at baseline in the treatment area
Outcome measures
| Measure |
PEP005 (Ingenol Mebutate) Gel
n=100 Participants
PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
|
Vehicle Gel
n=103 Participants
Vehicle gel once daily for 2 consecutive days
|
|---|---|---|
|
Proportion of Patients With Partial Clearance of Actinic Keratoses (AK) Lesions
|
55 participants
|
7 participants
|
Adverse Events
PEP005 (Ingenol Mebutate) Gel
Vehicle Gel
Serious adverse events
| Measure |
PEP005 (Ingenol Mebutate) Gel
n=100 participants at risk
PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
|
Vehicle Gel
n=103 participants at risk
Vehicle gel once daily for 2 consecutive days
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
1.0%
1/100 • 57 days
|
0.00%
0/103 • 57 days
|
|
General disorders
Chest Pain
|
1.0%
1/100 • 57 days
|
0.97%
1/103 • 57 days
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/100 • 57 days
|
0.97%
1/103 • 57 days
|
Other adverse events
| Measure |
PEP005 (Ingenol Mebutate) Gel
n=100 participants at risk
PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
|
Vehicle Gel
n=103 participants at risk
Vehicle gel once daily for 2 consecutive days
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Application site pruritus
|
16.0%
16/100 • 57 days
|
0.00%
0/103 • 57 days
|
|
Skin and subcutaneous tissue disorders
Application site irritation
|
6.0%
6/100 • 57 days
|
0.97%
1/103 • 57 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee For US sites: The institution and investigator agree not to publish the results of this study without prior written consent of the Sponsor. As used herein, the term "publish" shall include oral presentations,written abstracts, written manuscripts, etc.
- Publication restrictions are in place
Restriction type: OTHER