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

This study has been completed.
Sponsor:
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT00711178
First received: July 7, 2008
Last updated: November 1, 2010
Last verified: March 2008
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • response rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • immunosuppression
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00711178

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

No publications provided

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
Study First Received: July 7, 2008
Last Updated: November 1, 2010
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms
Aminolevulinic Acid
Methyl 5-aminolevulinate
 Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013