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
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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
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Sponsor:
Peplin
Information provided by (Responsible Party):
Peplin
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Study Type | Interventional |
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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 |
Participant Flow
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 |
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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 |
Baseline Characteristics
Arm/Group Title | PEP005 (Ingenol Mebutate) Gel | Vehicle Gel | Total | |
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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 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 100 participants | 103 participants | 203 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
48 48.0%
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52 50.5%
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100 49.3%
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>=65 years |
52 52.0%
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51 49.5%
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103 50.7%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 100 participants | 103 participants | 203 participants | |
Female |
41 41.0%
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35 34.0%
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76 37.4%
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Male |
59 59.0%
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68 66.0%
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127 62.6%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 100 participants | 103 participants | 203 participants |
100 | 103 | 203 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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
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):
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 |