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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00742391
First Posted: August 27, 2008
Last Update Posted: March 6, 2015
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.
Information provided by (Responsible Party):
Peplin
Results First Submitted: February 21, 2012  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study period was 05 September 2008 (first patient randomized) to 23 February 2009 (last patient completed Day 57)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    PEP005 (Ingenol Mebutate) Gel   Vehicle Gel
STARTED   126   129 
COMPLETED   122   128 
NOT COMPLETED   4   1 
Adverse Event                2                1 
Lost to Follow-up                1                0 
Protocol Violation                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
   PEP005 (Ingenol Mebutate) Gel   Vehicle Gel   Total 
Overall Participants Analyzed 
[Units: Participants]
 126   129   255 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.3  (10.59)   66.9  (9.89)   67.1  (10.22) 
Gender 
[Units: Participants]
     
Female   40   56   96 
Male   86   73   159 
Region of Enrollment 
[Units: Participants]
     
United States   110   116   226 
Australia   16   13   29 


  Outcome Measures
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1.  Primary:   Patients With Complete Clearance of Actinic Keratosis (AKs)   [ Time Frame: 57 days ]

2.  Secondary:   Patients With Partial Clearance of Actinic Keratosis (AKs)   [ Time Frame: baseline and 57 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr. Torsten Skov
Organization: LEO Pharma
phone: +4520736294
e-mail: torsten.skov@leo-pharma.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Peplin
ClinicalTrials.gov Identifier: NCT00742391     History of Changes
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