Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses (CoMet)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT01475071
First received: October 27, 2011
Last updated: March 17, 2016
Last verified: March 2016
Results First Received: August 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Actinic Keratoses
Interventions: Drug: Metvix and natural daylight PDT
Drug: Metvix and conventional PDT

  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
100 subjects recruited from March 2012 to May 2012 in private practice and clinic.

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

Reporting Groups
  Description
All Subjects Enrolled Intra-individual Comparison: all subjects have received Metvix and daylight photodynamic therapy on one side and Metvix and conventional photodynamic therapy on the other side

Participant Flow:   Overall Study
    All Subjects Enrolled  
STARTED     100  
COMPLETED     92  
NOT COMPLETED     8  
Physician Decision                 1  
Withdrawal by Subject                 6  
Lost to Follow-up                 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.
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Reporting Groups
  Description
All Subjects Enrolled Intra-individual Comparison: all subjects have received Metvix and daylight photodynamic therapy on one side and Metvix and conventional photodynamic therapy on the other side

Baseline Measures
    All Subjects Enrolled  
Number of Participants  
[units: participants]
  100  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     41  
>=65 years     59  
Age  
[units: years]
Mean (Standard Deviation)
  66.9  (10.5)  
Gender  
[units: participants]
 
Female     25  
Male     75  
Region of Enrollment  
[units: participants]
 
Australia     100  



  Outcome Measures
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1.  Primary:   Lesion Response   [ Time Frame: Week12 ]

2.  Primary:   Pain Score   [ Time Frame: Baseline (during procedure), assessed after procedure ]


  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: Cyril Moulin
Organization: Galderma
phone: +33 4 92 38 30 14
e-mail: cyril.moulin@galderma.com



Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01475071     History of Changes
Other Study ID Numbers: RD.03.SPR.29102
Study First Received: October 27, 2011
Results First Received: August 29, 2013
Last Updated: March 17, 2016
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration