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

This study has been completed.
Sponsor:
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT00365118
First received: August 15, 2006
Last updated: June 2, 2008
Last verified: June 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment

Resource links provided by NLM:

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

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

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00365118     History of Changes
Other Study ID Numbers: KF-01-278867
Study First Received: August 15, 2006
Last Updated: June 2, 2008
Health Authority: Denmark: The Ministry of the Interior and Health

Keywords provided by Bispebjerg Hospital:
Port wine stains
naevus flammeus

Additional relevant MeSH terms:
Port-Wine Stain
Skin Abnormalities
Congenital Abnormalities
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013