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 NCT00742391)

NCT ID: NCT00742391

Last Updated: 2015-03-06

Results Overview

Complete clearance rate of actinic keratosis (AK) lesions defined as the proportion of patients with no clinically visible AK lesions in the selected treatment area.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 255 participants
• Primary outcome timeframe: 57 days
• Results posted on: 2015-03-06

Participant Flow

The study period was 05 September 2008 (first patient randomized) to 23 February 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	126	129
Overall Study COMPLETED	122	128
Overall Study NOT COMPLETED	4	1

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 Adverse Event	2	1
Overall Study Lost to Follow-up	1	0
Overall Study Protocol Violation	1	0

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=126 Participants PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days	Vehicle Gel n=129 Participants Vehicle gel once daily for 2 consecutive days	Total n=255 Participants Total of all reporting groups
Age, Continuous	67.3 years STANDARD_DEVIATION 10.59 • n=5 Participants	66.9 years STANDARD_DEVIATION 9.89 • n=7 Participants	67.1 years STANDARD_DEVIATION 10.22 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	56 Participants n=7 Participants	96 Participants n=5 Participants
Sex: Female, Male Male	86 Participants n=5 Participants	73 Participants n=7 Participants	159 Participants n=5 Participants
Region of Enrollment United States	110 participants n=5 Participants	116 participants n=7 Participants	226 participants n=5 Participants
Region of Enrollment Australia	16 participants n=5 Participants	13 participants n=7 Participants	29 participants n=5 Participants

PRIMARY outcome

Timeframe: 57 days

Population: Intention to treat population

Complete clearance rate of actinic keratosis (AK) lesions defined as the proportion of patients with no clinically visible AK lesions in the selected treatment area.

Outcome measures

Measure	PEP005 (Ingenol Mebutate) Gel n=126 Participants PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days	Vehicle Gel n=129 Participants Vehicle gel once daily for 2 consecutive days
Patients With Complete Clearance of Actinic Keratosis (AKs)	35 Participants	6 Participants

SECONDARY outcome

Timeframe: baseline and 57 days

Population: Intention to treat population

Partial clearance rate of AK lesions defined as the proportion of patients with a 75% or greater reduction in the number of actinic keratosis (AK) lesions identified at baseline in the selected treatment area.

Outcome measures

Measure	PEP005 (Ingenol Mebutate) Gel n=126 Participants PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days	Vehicle Gel n=129 Participants Vehicle gel once daily for 2 consecutive days
Patients With Partial Clearance of Actinic Keratosis (AKs)	56 participants	6 participants

Adverse Events

PEP005 (Ingenol Mebutate) Gel

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Vehicle Gel

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	PEP005 (Ingenol Mebutate) Gel n=125 participants at risk PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days	Vehicle Gel n=129 participants at risk Vehicle gel once daily for 2 consecutive days
Injury, poisoning and procedural complications Cervical vertebral fracture	0.80% 1/125 • Number of events 1 • 57 days One patient in the PEP005 Gel, 0.05% group discontinued study medication (Day 2 dose not applied) due to an AE (application site pain)	0.00% 0/129 • 57 days One patient in the PEP005 Gel, 0.05% group discontinued study medication (Day 2 dose not applied) due to an AE (application site pain)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/125 • 57 days One patient in the PEP005 Gel, 0.05% group discontinued study medication (Day 2 dose not applied) due to an AE (application site pain)	0.78% 1/129 • Number of events 1 • 57 days One patient in the PEP005 Gel, 0.05% group discontinued study medication (Day 2 dose not applied) due to an AE (application site pain)
Cardiac disorders Angina pectoris	0.00% 0/125 • 57 days One patient in the PEP005 Gel, 0.05% group discontinued study medication (Day 2 dose not applied) due to an AE (application site pain)	0.78% 1/129 • Number of events 1 • 57 days One patient in the PEP005 Gel, 0.05% group discontinued study medication (Day 2 dose not applied) due to an AE (application site pain)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma (neck)	0.00% 0/125 • 57 days One patient in the PEP005 Gel, 0.05% group discontinued study medication (Day 2 dose not applied) due to an AE (application site pain)	0.78% 1/129 • Number of events 1 • 57 days One patient in the PEP005 Gel, 0.05% group discontinued study medication (Day 2 dose not applied) due to an AE (application site pain)

Other adverse events

Adverse event data not reported

Additional Information

Dr. Torsten Skov

LEO Pharma

Phone: +4520736294

Email: torsten.skov@leo-pharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee After the Study is completed, Institution shall have the right to publish their own data resulting from the Study upon the earlier of (a) publication of a multi-center publication coordinated by Sponsor or (b) the date of submission of the data resulting from the Study by Sponsor to the FDA. Institution shall furnish Sponsor with a copy of any proposed publication or release at least 90 days in advance of the proposed submission or presentation date.
• Publication restrictions are in place

Restriction type: OTHER