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

June 2, 2008 updated by: Bispebjerg Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen nv
      • Copenhagen, Copenhagen nv, Denmark, 2400
        • Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (ACTUAL)

December 1, 2007

Study Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

August 15, 2006

First Submitted That Met QC Criteria

August 16, 2006

First Posted (ESTIMATE)

August 17, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

June 3, 2008

Last Update Submitted That Met QC Criteria

June 2, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KF-01-278867

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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