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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00711178
First Posted: July 8, 2008
Last Update Posted: November 2, 2010
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:
Bispebjerg Hospital
  Purpose
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 Intervention
Actinic Keratoses Procedure: Photodynamic therapy with methyl aminolevulinate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

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

Estimated Enrollment: 150
Study Start Date: June 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: July 7, 2008
First Posted: July 8, 2008
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