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Short Incubation Methylaminolevulinate Photodynamic Therapy Without Occlusion

This study has been completed.
Sponsor:
Collaborator:
Galderma Canada
Information provided by (Responsible Party):
Innovaderm Research Inc.
ClinicalTrials.gov Identifier:
NCT00926952
First received: June 23, 2009
Last updated: September 1, 2011
Last verified: September 2011
History of Changes
Results First Received: January 21, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Actinic Keratosis
Interventions: Drug: Methylaminolevulinate (Metvix, Metvixia)
Device: Photodynamic Therapy (Aktilite)

  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
Recruitment period lasted from July 30, 2009 to July 14, 2010. Type of location was a medical research clinic.

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
MAL-PDT 90 Min Incubation, no Occlusion Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.

Participant Flow:   Overall Study
    MAL-PDT 90 Min Incubation, no Occlusion  
STARTED     20  
COMPLETED     20  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
MAL-PDT 90 Min Incubation, no Occlusion Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.

Baseline Measures
    MAL-PDT 90 Min Incubation, no Occlusion  
Number of Participants  
[units: participants]
 		  20  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     10  
>=65 years     10  
Age  
[units: years]
Mean ± Standard Deviation 		  65.25  ± 10.73  
Gender  
[units: participants]
 		 
Female     4  
Male     16  
Region of Enrollment  
[units: participants]
 		 
Canada     20  
Mean Number of Actinic Keratosis lesions on face  
[units: Lesions]
Mean ± Standard Deviation 		  9.85  ± 7.88  
Mean Griffiths Photonumeric Scale for Photodamage Score [1]
[units: Units on a scale.]
Mean ± Standard Deviation 		  5.40  ± 1.60  
Descriptive Scale -Mean Fine Wrinkling [2]
[units: Units on a scale]
Mean ± Standard Deviation 		  5.40  ± 1.76  
Descriptive Scale - Mean Coarse Wrinkling [3]
[units: Units on a scale]
Mean ± Standard Deviation 		  5.00  ± 2.20  
Descriptive Scale - Mean Sallowness [4]
[units: Units on a scale]
Mean ± Standard Deviation 		  3.60  ± 2.37  
Descriptive Scale - Mean Mottled Hyperpigmentation [5]
[units: Units on a scale]
Mean ± Standard Deviation 		  4.45  ± 2.14  
[1] Griffiths photonumeric scale was evaluated by the dermatologist. Patients were placed under natural daylight or fluorescent lighting for grading. A direct comparison was then made between the subjects and photographic standards (provided in reference 1). If an exact match could not be made to a grade then an inter-grade number was used used, for example 1, 3, 5, or 7. Zero (0) is the least amount of photodamage, 8 is the most amount of photodamage.
[2]

This factor represents a visual assessment of the number and depth of superficial wrinkles (i.e. shallow indentations or lines). Fine wrinkles typically appear in periorbital and perioral regions and are usually found further from the eyes and mouth than are coarse wrinkles.

  • Rating Category
  • 0 None
  • 1-3 Mild
  • 4-6 Moderate
  • 7-9 Severe
[3]

This factor represents a visual assessment of the number and depth of coarse wrinkles (i.e. deep lines, furrows, or creases). Coarse wrinkles appear on the forehead, glabella, chin, and nasolabial and periorbital areas, and they tend to be located closer to the eyes and mouth than fine wrinkles.

  • Rating Category
  • 0 None
  • 1-3 Mild
  • 4-6 Moderate
  • 7-9 Severe
[4]

This factor represents a visual assessment of color tone from very pink or rosy (0) to very sallow or pale (9).

  • Rating Category
  • 0 None
  • 1-3 Mild
  • 4-6 Moderate
  • 7-9 Severe
[5]

This factor represents a visual assessment of light, patchy, mottled hyperpigmentation and solar freckling (including melasma) based on quantitative criteria such as the area/density of pigment, color intensity (dark vs. light), and uniformity of distribution (i.e. the more uneven or blotchy, the greater the score), Lentigines, nevi, and other pigmented lesions are not to be included in this assessment.

  • Rating Category
  • 0 None
  • 1-3 Mild
  • 4-6 Moderate
  • 7-9 Severe



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Number of Facial Actinic Keratoses at Week 12   [ Time Frame: 12 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Number of Patients With Complete Clinical Response of All Actinic Keratoses at Week 12   [ Time Frame: 12 weeks ]
  Show Outcome Measure 2

3.  Secondary:   Number of Actinic Keratosis Lesions With Complete Clinical Response at Day 0 and Week 12   [ Time Frame: 0, 12 weeks ]
  Show Outcome Measure 3

4.  Secondary:   Mean Griffiths Photonumeric Scale for Photodamage Score at Week 12   [ Time Frame: 12 weeks ]
  Show Outcome Measure 4

5.  Secondary:   Mean Fine Wrinkling Score at Week 12   [ Time Frame: 12 weeks ]
  Show Outcome Measure 5

6.  Secondary:   Mean Coarse Wrinkling Score at Week 12   [ Time Frame: 12 weeks ]
  Show Outcome Measure 6

7.  Secondary:   Mean Sallowness Score at Week 12   [ Time Frame: 12 weeks ]
  Show Outcome Measure 7

8.  Secondary:   Mean Mottled Hyperpigmentation at Week 12   [ Time Frame: 12 weeks ]
  Show Outcome Measure 8

9.  Secondary:   Number of Adverse Events   [ Time Frame: 12, 24 weeks ]
  Show Outcome Measure 9


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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: Annie Levesque
Organization: Innovaderm Research Inc.
phone: 514-521-4285 ext 222
e-mail: alevesque@innovaderm.ca


Publications:


Responsible Party: Innovaderm Research Inc.
ClinicalTrials.gov Identifier: NCT00926952     History of Changes
Other Study ID Numbers: Inno-6010
Study First Received: June 23, 2009
Results First Received: January 21, 2011
Last Updated: September 1, 2011
Health Authority: Canada: Health Canada