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

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. Identifier: NCT00365118
Recruitment Status : Completed
First Posted : August 17, 2006
Last Update Posted : June 3, 2008
Information provided by:
Bispebjerg Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Port-Wine Stain Device: Pulsed dye laser (Candela), Intense pulsed light (Palomar) Not Applicable

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Study Start Date : November 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

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MedlinePlus related topics: Birthmarks Moles
U.S. FDA Resources

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

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.).

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 identifier (NCT number): NCT00365118

Bispebjerg Hospital
Copenhagen, Copenhagen nv, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
Principal Investigator: Merete Hædersdal, MD, PhD, DrMedSci Bispebjerg Hospital Identifier: NCT00365118     History of Changes
Other Study ID Numbers: KF-01-278867
First Posted: August 17, 2006    Key Record Dates
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
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type