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A Simultaneous Treatment Regimen Compared to a Sequential Treatment Regimen With Ingenol Mebutate Gel 0.015% and 0.05% of Two Areas With Actinic Keratosis on Face/Scalp and Trunk/Extremities

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01787383
First Posted: February 8, 2013
Last Update Posted: May 7, 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):
LEO Pharma
Results First Submitted: December 18, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Actinic Keratosis
Interventions: Drug: Ingenol mebutate gel 0.05 %
Drug: Ingenol mebutate gel 0.015 %

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In the clinical study protocol 200 subjects were planned to be enrolled and 199 subjects were actually enrolled and randomised.

Reporting Groups
  Description
Ingenol Mebutate Gel Simultaneous Treatment Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
Ingenol Mebutate Gel Sequential Treatment Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.

Participant Flow:   Overall Study
    Ingenol Mebutate Gel Simultaneous Treatment   Ingenol Mebutate Gel Sequential Treatment
STARTED   101   98 
COMPLETED   92   76 
NOT COMPLETED   9   22 



  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.
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Reporting Groups
  Description
Ingenol Mebutate Gel Simultaneous Treatment

Ingenol mebutate gel 0.05 %: Ingenol mebutate gel 0.05 % (Picato®) on trunk/extremities applied simultaneously

Ingenol mebutate gel 0.015 %: Ingenol mebutate gel 0.015 % (Picato®) on face/scalp applied simultaneously

Ingenol Mebutate Gel Sequential Treatment

Ingenol mebutate gel 0.05 %: Ingenol mebutate gel 0.05 % (Picato®) on trunk/extremities applied sequentially

Ingenol mebutate gel 0.015 %: Ingenol mebutate gel 0.015 % (Picato®) on face/scalp applied sequentially

Total Total of all reporting groups

Baseline Measures
   Ingenol Mebutate Gel Simultaneous Treatment   Ingenol Mebutate Gel Sequential Treatment   Total 
Overall Participants Analyzed 
[Units: Participants]
 101   98   199 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   12   9   21 
>=65 years   89   89   178 
Age 
[Units: Years]
Mean (Full Range)
 74.4 
 (43 to 94) 
 74.5 
 (48 to 92) 
 74.5 
 (43 to 94) 
Gender 
[Units: Participants]
     
Female   13   18   31 
Male   88   80   168 
Region of Enrollment 
[Units: Participants]
     
Italy   63   61   124 
Spain   38   37   75 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Composite Local Skin Reaction (LSR) Score 3 Days After Treatment of Each Selected Treatment Area   [ Time Frame: 3 days after treatment of each selected treatment area ]

2.  Secondary:   Complete Clearance of AKs in Each Separate Treatment Area 8 Weeks After Treatment   [ Time Frame: 8 weeks after treatment ]

3.  Secondary:   Partial Clearance of AKs in Each Separate Treatment Area 8 Weeks After Treatment   [ Time Frame: 8 weeks after treatment ]

4.  Secondary:   Percent Reduction in Number of AKs in Each Separate Treatment Area 8 Weeks After Treatment   [ Time Frame: 8 weeks after treatment ]

5.  Secondary:   Effectiveness Satisfaction Questionnaire for Medication (TSQM)   [ Time Frame: 8 weeks ]

6.  Secondary:   Side Effects TSQM   [ Time Frame: 8 weeks ]

7.  Secondary:   Global Satisfaction TSQM   [ Time Frame: 8 weeks ]

8.  Secondary:   Convenience TSQM   [ Time Frame: 8 weeks ]


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Clinical trial disclosure manager
Organization: LEO Pharma A/S
phone: 00 45 44 94 58 88
e-mail: ctr.disclosure@leopharma.com


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

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01787383     History of Changes
Other Study ID Numbers: LP0041-64
2012-002863-88 ( EudraCT Number )
First Submitted: February 6, 2013
First Posted: February 8, 2013
Results First Submitted: December 18, 2014
Results First Posted: May 7, 2015
Last Update Posted: May 7, 2015