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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: NCT00942604
Recruitment Status : Completed
First Posted : July 21, 2009
Results First Posted : March 19, 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 203
Recruitment Details The study period was 22 July 2009 (first patient randomized) to 14 October 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 100 103
Completed 98 99
Not Completed 2 4
Reason Not Completed
Protocol Violation             1             1
Adverse Event             0             1
Withdrawal by Subject             0             1
Patient relocation             1             1
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 100 103 203
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 103 participants 203 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
48
  48.0%
52
  50.5%
100
  49.3%
>=65 years
52
  52.0%
51
  49.5%
103
  50.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 103 participants 203 participants
Female
41
  41.0%
35
  34.0%
76
  37.4%
Male
59
  59.0%
68
  66.0%
127
  62.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 100 participants 103 participants 203 participants
100 103 203
1.Primary Outcome
Title Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions
Hide Description Proportion of Patients with Complete Clearance of the treatment field defined as no clinically visible Actinic Keratoses (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 100 103
Measure Type: Number
Unit of Measure: participants
42 5
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 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
2.Secondary Outcome
Title Proportion of Patients With Partial Clearance of Actinic Keratoses (AK) Lesions
Hide Description 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
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 100 103
Measure Type: Number
Unit of Measure: participants
55 7
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 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Time Frame 57 days
Adverse Event Reporting Description [Not Specified]
 
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 (%) Affected / at Risk (%)
Total   2/100 (2.00%)   2/103 (1.94%) 
Cardiac disorders     
Myocardial infarction * 1  0/100 (0.00%)  1/103 (0.97%) 
Gastrointestinal disorders     
Abdominal Pain * 1  1/100 (1.00%)  0/103 (0.00%) 
General disorders     
Chest Pain * 1  1/100 (1.00%)  1/103 (0.97%) 
*
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 (%) Affected / at Risk (%)
Total   18/100 (18.00%)   1/103 (0.97%) 
Skin and subcutaneous tissue disorders     
Application site pruritus * 1  16/100 (16.00%)  0/103 (0.00%) 
Application site irritation * 1  6/100 (6.00%)  1/103 (0.97%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)
[Not Specified]
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.
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.
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Peplin
ClinicalTrials.gov Identifier: NCT00942604    
Other Study ID Numbers: PEP005-028
First Submitted: July 19, 2009
First Posted: July 21, 2009
Results First Submitted: February 21, 2012
Results First Posted: March 19, 2012
Last Update Posted: March 6, 2015