Completed

Treatment of Nevus Flammeus With Alexandrite Laser

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What is being tested

Alexandrite laser

Procedure
Who is being recruted

Congenital Abnormalities+3

+ Congenital, Hereditary, and Neonatal Diseases and Abnormalities

+ Skin Abnormalities

Over 10 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2013
See protocol details

Summary

Principal SponsorBispebjerg Hospital
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2013

Actual date on which the first participant was enrolled.

Nevus flammeus is a congenital vascular malformation. Nevus flammeus is traditionally treated with pulsed dye lasers (PDL); however, around 20 percent of patients are poor responders and do not get satisfactory results from pulsed dye laser treatments. Small studies with alexandrite lasers indicate that this may be an alternative treatment for individuals with nevus flammeus. This study assesses the clinical effect and side effects of alexandrite laser treatment for nevus flammeus using different treatment settings.

Official TitleTreatment of Nevus Flammeus With Alexandrite Laser
NCT01968681
Principal SponsorBispebjerg Hospital
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

19 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 10 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin AbnormalitiesSkin DiseasesSkin and Connective Tissue DiseasesPort-Wine Stain

Criteria

5 inclusion criteria required to participate
10 or more years of age
Fitzpatrick Skin Type I-III
Previously untreated or pulsed dye laser-insufficiently treated nevus flammeus
Nevus flammeus size minimum 8 x 2 centimeter within one anatomical region
Show More Criteria
7 exclusion criteria prevent from participating
Known light sensibility toward visible light
Tendency to develop hypertrophic scars or keloids
Fitzpatrick Skin Type IV-VI
Individuals, that are obviously pigmented due to recent sun exposure or sun beds
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Bispebjerg Hospital

Copenhagen, DenmarkOpen Bispebjerg Hospital in Google Maps
CompletedOne Study Center