Trial Outcomes & Findings for A Multi-Center Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on the Head (Face or Scalp) (NCT NCT00915551)

NCT ID: NCT00915551

Last Updated: 2015-03-06

Results Overview

Complete clearance of the treatment field

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 278 participants
• Primary outcome timeframe: baseline and 57 days
• Results posted on: 2015-03-06

Participant Flow

Study PEP005-025 was conducted at 21 study centers in the United States (19) and Australia (2). A total of 278 patients were randomized (255 (92%) in the US and 23 (8%) in Australia). Patient screening was started on 05 May 2009. The first patient was randomized on 05 June 2009 and the last patient completed the Day 57 visit on 02 September 2009.

Participant milestones

Measure	PEP005 (Ingenol Mebutate) Gel, 0.015% PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days	Vehicle Gel Vehicle gel once daily for 3 consecutive days
Overall Study STARTED	142	136
Overall Study COMPLETED	142	135
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	PEP005 (Ingenol Mebutate) Gel, 0.015% PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days	Vehicle Gel Vehicle gel once daily for 3 consecutive days
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

A Multi-Center Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on the Head (Face or Scalp)

Baseline characteristics by cohort

Measure	PEP005 (Ingenol Mebutate) Gel, 0.015% n=142 Participants PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days	Vehicle Gel n=136 Participants Vehicle gel once daily for 3 consecutive days	Total n=278 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	73 Participants n=5 Participants	63 Participants n=7 Participants	136 Participants n=5 Participants
Age, Categorical >=65 years	69 Participants n=5 Participants	73 Participants n=7 Participants	142 Participants n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	24 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	117 Participants n=5 Participants	112 Participants n=7 Participants	229 Participants n=5 Participants
Region of Enrollment United States	131 participants n=5 Participants	124 participants n=7 Participants	255 participants n=5 Participants
Region of Enrollment Australia	11 participants n=5 Participants	12 participants n=7 Participants	23 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 57 days

Population: Intention to treat population

Complete clearance of the treatment field

Outcome measures

Measure	PEP005 (Ingenol Mebutate) Gel, 0.015% n=142 Participants PEP005 (Ingenol Mebutate) gel, 0.015% once daily for 3 consecutive days	Vehicle Gel n=136 Participants Vehicle gel once daily for 3 consecutive days
Complete Clearance of Actinic Keratoses (AK) Lesions	67 participants Interval to 55.7	7 participants Interval 2.1 to 10.3

SECONDARY outcome

Timeframe: baseline and 57 days

Population: Intention to treat population

Partial clearance defined as ≥ 75% reduction in the number of AK lesions identified at baseline in the treatment area

Outcome measures

Measure	PEP005 (Ingenol Mebutate) Gel, 0.015% n=142 Participants PEP005 (Ingenol Mebutate) gel, 0.015% once daily for 3 consecutive days	Vehicle Gel n=136 Participants Vehicle gel once daily for 3 consecutive days
Partial Clearance of Actinic Keratoses (AK)	96 participants	11 participants

Adverse Events

PEP005 (Ingenol Mebutate) Gel, 0.015%

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Vehicle Gel

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	PEP005 (Ingenol Mebutate) Gel, 0.015% n=142 participants at risk PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days	Vehicle Gel n=136 participants at risk Vehicle gel once daily for 3 consecutive days
Surgical and medical procedures Hip Arthroplasty (Hip Replacement)	0.70% 1/142 • Number of events 1 • 57 days	0.00% 0/136 • 57 days
Cardiac disorders Myocardial Infarction	0.70% 1/142 • Number of events 1 • 57 days	0.00% 0/136 • 57 days

Other adverse events

Measure	PEP005 (Ingenol Mebutate) Gel, 0.015% n=142 participants at risk PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days	Vehicle Gel n=136 participants at risk Vehicle gel once daily for 3 consecutive days
Skin and subcutaneous tissue disorders Application site pain	12.0% 17/142 • 57 days	0.74% 1/136 • 57 days
Skin and subcutaneous tissue disorders Application site pruritus	5.6% 8/142 • 57 days	0.00% 0/136 • 57 days

Additional Information

Dr. Torsten Skov

LEO Pharma

Phone: +4520736294

Email: torsten.skov@leo-pharma.com

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