A Phase 3 interventional study of PEP005 (Ingenol Mebutate) gel, 0.015% and Vehicle Gel in Actinic Keratosis, sponsored by Peplin. Completed at 21 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-06.
Sponsored by Peplin (part of LEO Pharma) · Phase 3, Interventional, and Treatment
This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when applied to an area of skin containing 4-8 AK lesions on the face or scalp.
369 studies on the registry are indexed under Keratosis, Actinic; 30 are open to participants now.
This study's enrollment of 278 is above the median of 60 across 318 interventional studies indexed under Keratosis, Actinic.
Browse Keratosis, Actinic studies →Peplin is the lead sponsor of 29 studies on the registry; none are open to participants now.
First submitted before Peplin became part of LEO Pharma.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Female patients must be of either:
Exclusion Criteria:
Drug: PEP005 (Ingenol Mebutate) gel, 0.015%
Drug: Vehicle Gel
once daily for 3 consecutive days
once daily for 3 consecutive days
Complete Clearance of Actinic Keratoses (AK) Lesions
Complete clearance of the treatment field
Time frame: baseline and 57 days
Partial Clearance of Actinic Keratoses (AK)
Partial clearance defined as ≥ 75% reduction in the number of AK lesions identified at baseline in the treatment area
Time frame: baseline and 57 days
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.
| Milestone | PEP005 (Ingenol Mebutate) Gel, 0.015% | Vehicle Gel |
|---|---|---|
| Started | 142 | 136 |
| Completed | 142 | 135 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
Complete clearance of the treatment field
| participants | PEP005 (Ingenol Mebutate) Gel, 0.015% | Vehicle Gel |
|---|---|---|
| Complete Clearance of Actinic Keratoses (AK) Lesions | 67 (— to 55.7) | 7 (2.1 to 10.3) |
Partial clearance defined as ≥ 75% reduction in the number of AK lesions identified at baseline in the treatment area
| participants | PEP005 (Ingenol Mebutate) Gel, 0.015% | Vehicle Gel |
|---|---|---|
| Partial Clearance of Actinic Keratoses (AK) | 96 | 11 |
Collected over 57 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PEP005 (Ingenol Mebutate) Gel, 0.015% | — | 1/142 (0.7%) | 20/142 (14.1%) |
| Vehicle Gel | — | 0/136 (0%) | 1/136 (0.7%) |
| Event | PEP005 (Ingenol Mebutate) Gel, 0.015% | Vehicle Gel |
|---|---|---|
| Hip Arthroplasty (Hip Replacement)Surgical and medical procedures | 1/142 | 0/136 |
| Myocardial InfarctionCardiac disorders | 1/142 | 0/136 |
| Event | PEP005 (Ingenol Mebutate) Gel, 0.015% | Vehicle Gel |
|---|---|---|
| Application site painSkin and subcutaneous tissue disorders | 17/142 | 1/136 |
| Application site pruritusSkin and subcutaneous tissue disorders | 8/142 | 0/136 |
| Age, Categorical(Participants) | PEP005 (Ingenol Mebutate) Gel, 0.015% | Vehicle Gel | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 73 | 63 | 136 |
| >=65 years | 69 | 73 | 142 |
| Sex: Female, Male(Participants) | PEP005 (Ingenol Mebutate) Gel, 0.015% | Vehicle Gel | Total |
|---|---|---|---|
| Female | 25 | 24 | 49 |
| Male | 117 | 112 | 229 |
| Region of Enrollment(participants) | PEP005 (Ingenol Mebutate) Gel, 0.015% | Vehicle Gel | Total |
|---|---|---|---|
| United States | 131 | 124 | 255 |
| Australia | 11 | 12 | 23 |
The record gives a start of Jun 2009, a primary completion of Sep 2009 and a completion of Sep 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2012, 2 years 6 months after primary completion. A results delay was requested in Sep 2010.
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This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ingenol mebutate