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Treatment of Naevus Flammeus Using Intense Pulsed Light and Pulsed Dye Laser

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00365118
First Posted: August 17, 2006
Last Update Posted: June 3, 2008
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
The purpose of the trial is to compare efficacy and adverse effects of pulsed dye laser and intense pulsed light in patients with port wine stains.

Condition Intervention
Port-Wine Stain Device: Pulsed dye laser (Candela), Intense pulsed light (Palomar)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Study Start Date: November 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Patients with previously untreated and previously laser-treated naevus flammeus. Naevus flammeus measuring at least 5 x 7 cm within a single anatomical area. For example, the face corresponding to dermatomes V1, V2 and V3, back, abdomen, arms and legs.Patients aged two or above.Patients with skin types I-III.

Exclusion Criteria:

  • Patients below two years of age.
  • Pregnant or breastfeeding patients.
  • Patients with known increased sensitivity to visible light.
  • Patients with a tendency to produce hypertrophic scars or celoids.
  • Patients with skin types IV, V and VI.
  • Patients who are clearly pigmented following recent exposure to the sun or a solarium.
  • Patients treated with Roaccutane during the last six months.
  • Patients who are not considered able to follow the treatment protocol (e.g. severely alcoholic patients, dementia patients, mentally ill patients, etc.).
  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): NCT00365118


Locations
Denmark
Bispebjerg Hospital
Copenhagen, Copenhagen nv, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
Principal Investigator: Merete Hædersdal, MD, PhD, DrMedSci Bispebjerg Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00365118     History of Changes
Other Study ID Numbers: KF-01-278867
First Submitted: August 15, 2006
First Posted: August 17, 2006
Last Update Posted: June 3, 2008
Last Verified: June 2008

Keywords provided by Bispebjerg Hospital:
Port wine stains
naevus flammeus

Additional relevant MeSH terms:
Port-Wine Stain
Hemangioma, Capillary
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms