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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

203 participants

Primary outcome timeframe

57 days

Results posted on

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

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

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

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 days

Population: 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

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 days

Population: 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

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

Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths

Vehicle Gel

Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

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

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

Dr. Torsten Skov

LEO Pharma

Phone: +4520736294

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