Back to resultsA Randomized Multicenter Study of Daylight Mediated Photodynamic Therapy (PDT)
Primary Purpose
Actinic Keratoses
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Photodynamic therapy with methyl aminolevulinate
Sponsored by
About this trial
This is an interventional treatment trial for Actinic Keratoses
Eligibility Criteria
Inclusion Criteria:
- 18 years and older, 5 AK in face and scalp
Exclusion Criteria:
- immunosuppression
Sites / Locations
- Bispebjerg Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
A
B
Arm Description
2 hours sunlight
3 hours of sunlight
Outcomes
Primary Outcome Measures
response rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00711178
Brief Title
A Randomized Multicenter Study of Daylight Mediated Photodynamic Therapy (PDT)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bispebjerg Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A randomised, multi-center study of daylight mediated photodynamic therapy (PDT) with Metvix in patients with multiple actinic keratosis on the face and/or scalp.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratoses
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
2 hours sunlight
Arm Title
B
Arm Type
Active Comparator
Arm Description
3 hours of sunlight
Intervention Type
Procedure
Intervention Name(s)
Photodynamic therapy with methyl aminolevulinate
Intervention Description
daylight mediated photodynamic therapy
Primary Outcome Measure Information:
Title
response rate
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years and older, 5 AK in face and scalp
Exclusion Criteria:
immunosuppression
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans Christian Wulf, Professor
Organizational Affiliation
Bispebjerg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
A Randomized Multicenter Study of Daylight Mediated Photodynamic Therapy (PDT)
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