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

Primary Purpose

Port-Wine Stain

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Pulsed dye laser (Candela), Intense pulsed light (Palomar)
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Port-Wine Stain focused on measuring Port wine stains, naevus flammeus

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All Sexes

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.).

Sites / Locations

  • Bispebjerg Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 15, 2006
Last Updated
June 2, 2008
Sponsor
Bispebjerg Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00365118
Brief Title
Treatment of Naevus Flammeus Using Intense Pulsed Light and Pulsed Dye Laser
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bispebjerg Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Port-Wine Stain
Keywords
Port wine stains, naevus flammeus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Pulsed dye laser (Candela), Intense pulsed light (Palomar)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Eligibility 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.).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merete Hædersdal, MD, PhD, DrMedSci
Organizational Affiliation
Bispebjerg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen
State/Province
Copenhagen nv
ZIP/Postal Code
2400
Country
Denmark

12. IPD Sharing Statement

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

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