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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 22, 2014