Treatment of Nevus Flammeus With Alexandrite Laser

February 22, 2015 updated by: Merete Haedersdal, Bispebjerg Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

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, 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

10 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
  • Written and oral informed consent

Exclusion Criteria:

  • 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
  • Treatment with systemic retinoids within 6 months
  • Pregnancy and lactation
  • Unwillingness to complete protocol

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Alexandrite laser treatment
Procedure: Alexandrite laser
3 different alexandrite laser settings are used in respectively 3 different treatment areas and compared with a non-treated control area.
Other Names:
  • Candela Gentle Max

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in clinical appearance on a 10-point scale
Time Frame: 6-8 weeks
6-8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Skin reflectance measurement to assess degree of redness
Time Frame: 6-8 weeks
6-8 weeks
Skin reflectance to assess degree of pigmentation
Time Frame: 6-8 weeks
6-8 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Clinical assessment of pigmentation
Time Frame: 6-8 weeks
6-8 weeks
Clinical assessment of scar tissue formation
Time Frame: 6-8 weeks
6-8 weeks

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

September 1, 2013

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

October 21, 2013

First Submitted That Met QC Criteria

October 21, 2013

First Posted (ESTIMATE)

October 24, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 24, 2015

Last Update Submitted That Met QC Criteria

February 22, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-4-2013-066

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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