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

NCT ID: NCT00365118

Last Updated: 2008-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Port-Wine Stain

Keywords

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Port wine stains naevus flammeus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Pulsed dye laser (Candela), Intense pulsed light (Palomar)

Intervention Type DEVICE

Eligibility Criteria

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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.).
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Merete Hædersdal, MD, PhD, DrMedSci

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Locations

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Bispebjerg Hospital

Copenhagen, Copenhagen Nv, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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KF-01-278867

Identifier Type: -

Identifier Source: org_study_id