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:
Information provided by (Responsible Party):
Peplin
ClinicalTrials.gov Identifier:
NCT00742391
First received: August 25, 2008
Last updated: March 29, 2012
Last verified: March 2012
Results First Received: February 21, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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  
Number of Participants  
[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


No publications provided by Peplin

Publications automatically indexed to this study:

Responsible Party: Peplin
ClinicalTrials.gov Identifier: NCT00742391     History of Changes
Other Study ID Numbers: PEP005-014
Study First Received: August 25, 2008
Results First Received: February 21, 2012
Last Updated: March 29, 2012
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration