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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00742391
Recruitment Status : Completed
First Posted : August 27, 2008
Results First Posted : March 21, 2012
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
Peplin

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Actinic Keratoses
Interventions Drug: PEP005 (ingenol mebutate) Gel
Drug: Vehicle gel
Enrollment 255
Recruitment Details The study period was 05 September 2008 (first patient randomized) to 23 February 2009 (last patient completed Day 57)
Pre-assignment Details  
Arm/Group Title PEP005 (Ingenol Mebutate) Gel Vehicle Gel
Hide Arm/Group Description PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days Vehicle gel once daily for 2 consecutive days
Period Title: Overall Study
Started 126 129
Completed 122 128
Not Completed 4 1
Reason Not Completed
Adverse Event             2             1
Lost to Follow-up             1             0
Protocol Violation             1             0
Arm/Group Title PEP005 (Ingenol Mebutate) Gel Vehicle Gel Total
Hide Arm/Group Description PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days Vehicle gel once daily for 2 consecutive days Total of all reporting groups
Overall Number of Baseline Participants 126 129 255
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 126 participants 129 participants 255 participants
67.3  (10.59) 66.9  (9.89) 67.1  (10.22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants 129 participants 255 participants
Female
40
  31.7%
56
  43.4%
96
  37.6%
Male
86
  68.3%
73
  56.6%
159
  62.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 126 participants 129 participants 255 participants
United States 110 116 226
Australia 16 13 29
1.Primary Outcome
Title Patients With Complete Clearance of Actinic Keratosis (AKs)
Hide Description 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.
Time Frame 57 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat population
Arm/Group Title PEP005 (Ingenol Mebutate) Gel Vehicle Gel
Hide Arm/Group Description:
PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
Vehicle gel once daily for 2 consecutive days
Overall Number of Participants Analyzed 126 129
Measure Type: Number
Unit of Measure: Participants
35 6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEP005 (Ingenol Mebutate) Gel, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
2.Secondary Outcome
Title Patients With Partial Clearance of Actinic Keratosis (AKs)
Hide Description 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.
Time Frame baseline and 57 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat population
Arm/Group Title PEP005 (Ingenol Mebutate) Gel Vehicle Gel
Hide Arm/Group Description:
PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
Vehicle gel once daily for 2 consecutive days
Overall Number of Participants Analyzed 126 129
Measure Type: Number
Unit of Measure: participants
56 6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEP005 (Ingenol Mebutate) Gel, Vehicle Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Time Frame 57 days
Adverse Event Reporting Description One patient in the PEP005 Gel, 0.05% group discontinued study medication (Day 2 dose not applied) due to an AE (application site pain)
 
Arm/Group Title PEP005 (Ingenol Mebutate) Gel Vehicle Gel
Hide Arm/Group Description PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days Vehicle gel once daily for 2 consecutive days
All-Cause Mortality
PEP005 (Ingenol Mebutate) Gel Vehicle Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
PEP005 (Ingenol Mebutate) Gel Vehicle Gel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/125 (0.80%)      3/129 (2.33%)    
Cardiac disorders     
Angina pectoris * 1  0/125 (0.00%)  0 1/129 (0.78%)  1
Injury, poisoning and procedural complications     
Cervical vertebral fracture * 1  1/125 (0.80%)  1 0/129 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer * 1  0/125 (0.00%)  0 1/129 (0.78%)  1
Lymphoma (neck) * 1  0/125 (0.00%)  0 1/129 (0.78%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PEP005 (Ingenol Mebutate) Gel Vehicle Gel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/125 (0.00%)      0/129 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Torsten Skov
Organization: LEO Pharma
Phone: +4520736294
EMail: torsten.skov@leo-pharma.com
Layout table for additonal information
Responsible Party: Peplin
ClinicalTrials.gov Identifier: NCT00742391    
Other Study ID Numbers: PEP005-014
First Submitted: August 25, 2008
First Posted: August 27, 2008
Results First Submitted: February 21, 2012
Results First Posted: March 21, 2012
Last Update Posted: March 6, 2015