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A Multi-Center Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on the Head (Face or Scalp)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peplin
ClinicalTrials.gov Identifier:
NCT00915551
First received: June 4, 2009
Last updated: November 22, 2013
Last verified: November 2013
Results First Received: February 21, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Actinic Keratosis
Interventions: Drug: PEP005 (Ingenol Mebutate) gel, 0.015%
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
Study PEP005-025 was conducted at 21 study centers in the United States (19) and Australia (2). A total of 278 patients were randomized (255 (92%) in the US and 23 (8%) in Australia). Patient screening was started on 05 May 2009. The first patient was randomized on 05 June 2009 and the last patient completed the Day 57 visit on 02 September 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None

Reporting Groups
  Description
PEP005 (Ingenol Mebutate) Gel, 0.015% PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
Vehicle Gel Vehicle gel once daily for 3 consecutive days

Participant Flow:   Overall Study
    PEP005 (Ingenol Mebutate) Gel, 0.015%     Vehicle Gel  
STARTED     142     136  
COMPLETED     142     135  
NOT COMPLETED     0     1  
Withdrawal by Subject                 0                 1  



  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, 0.015% PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
Vehicle Gel Vehicle gel once daily for 3 consecutive days
Total Total of all reporting groups

Baseline Measures
    PEP005 (Ingenol Mebutate) Gel, 0.015%     Vehicle Gel     Total  
Number of Participants  
[units: participants]
  142     136     278  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     73     63     136  
>=65 years     69     73     142  
Gender  
[units: participants]
     
Female     25     24     49  
Male     117     112     229  
Region of Enrollment  
[units: participants]
     
United States     131     124     255  
Australia     11     12     23  



  Outcome Measures
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1.  Primary:   Complete Clearance of Actinic Keratoses (AK) Lesions   [ Time Frame: baseline and 57 days ]

2.  Secondary:   Partial Clearance of Actinic Keratoses (AK)   [ 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: NCT00915551     History of Changes
Other Study ID Numbers: PEP005-025
Study First Received: June 4, 2009
Results First Received: February 21, 2012
Last Updated: November 22, 2013
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration