Skip to main content
OpenTrials
Completed

NCT Number: NCT01968681

Treatment of Nevus Flammeus With Alexandrite Laser

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Nevus Flammeus Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Port-Wine Stain Skin Abnormalities Skin Diseases Skin and Connective Tissue Diseases

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alexandrite laser

Procedure

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

Primary outcomes

  1. Reduction in clinical appearance on a 10-point scale

    Time frame: 6-8 weeks

Secondary outcomes

  1. Skin reflectance measurement to assess degree of redness

    Time frame: 6-8 weeks

  2. Skin reflectance to assess degree of pigmentation

    Time frame: 6-8 weeks

Other outcomes

  1. Clinical assessment of pigmentation

    Time frame: 6-8 weeks

  2. Clinical assessment of scar tissue formation

    Time frame: 6-8 weeks

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 24, 2013
Registry last updated
Feb 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.