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:
NCT00916006
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 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
Study PEP005-016 was conducted at 21 study centers in the United States and Australia. A total of 269 patients were randomized. Patient screening was started on 01 June 2009. The first patient was randomized on 05 June 2009 and the last patient completed the Day 57 visit on 10 September 2009

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, 0.015% PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
Vehicle Vehicle gel once daily for 3 consecutive days

Participant Flow:   Overall Study
    PEP005 (Ingenol Mebutate) Gel, 0.015%     Vehicle  
STARTED     135     134  
COMPLETED     132     127  
NOT COMPLETED     3     7  
Adverse Event                 1                 1  
Withdrawal by Subject                 2                 5  
Protocol Violation                 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 Vehicle gel once daily for 3 consecutive days
Total Total of all reporting groups

Baseline Measures
    PEP005 (Ingenol Mebutate) Gel, 0.015%     Vehicle     Total  
Number of Participants  
[units: participants]
  135     134     269  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     71     77     148  
>=65 years     64     57     121  
Gender  
[units: participants]
     
Female     19     14     33  
Male     116     120     236  
Region of Enrollment  
[units: participants]
     
United States     125     126     251  
Australia     10     8     18  



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

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


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
No text entered.  


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


No publications provided by Peplin

Publications automatically indexed to this study:

Responsible Party: Peplin
ClinicalTrials.gov Identifier: NCT00916006     History of Changes
Other Study ID Numbers: PEP005-016
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