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A Randomized Multicenter Study of Daylight Mediated Photodynamic Therapy (PDT)

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ClinicalTrials.gov Identifier: NCT00711178
Recruitment Status : Completed
First Posted : July 8, 2008
Last Update Posted : November 2, 2010
Sponsor:
Information provided by:
Bispebjerg Hospital

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.

Condition or disease Intervention/treatment Phase
Actinic Keratoses Procedure: Photodynamic therapy with methyl aminolevulinate Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : June 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A
2 hours sunlight
Procedure: Photodynamic therapy with methyl aminolevulinate
daylight mediated photodynamic therapy
Active Comparator: B
3 hours of sunlight
Procedure: Photodynamic therapy with methyl aminolevulinate
daylight mediated photodynamic therapy



Primary Outcome Measures :
  1. response rate [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years and older, 5 AK in face and scalp

Exclusion Criteria:

  • immunosuppression

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00711178


Locations
Denmark
Bispebjerg Hospital
Copenhagen, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
Principal Investigator: Hans Christian Wulf, Professor Bispebjerg Hospital

Responsible Party: Professor Hans Christian Wulf, Department of Dermatology, Bispebjerg Hospital, Denmark, Bispebjerg Hospital, University of Copenhagen, Denmark
ClinicalTrials.gov Identifier: NCT00711178     History of Changes
Other Study ID Numbers: Multicenter Sun-PDT
First Posted: July 8, 2008    Key Record Dates
Last Update Posted: November 2, 2010
Last Verified: March 2008

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms
Aminolevulinic Acid
Methyl 5-aminolevulinate
Photosensitizing Agents
Dermatologic Agents