Treatment of Nevus Flammeus With Alexandrite Laser

N/ACompletedNCT01968681

Bispebjerg Hospital19 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Nevus Flammeus

Interventions

Alexandrite laserPROCEDURE

3 different alexandrite laser settings are used in respectively 3 different treatment areas and compared with a non-treated control area.

Eligibility

Sex: ALLMin age: 10 Years

Medical Language ↔ Plain English

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

Locations (1)

Bispebjerg Hospital

Copenhagen, Denmark

Outcomes

Primary Outcomes

Reduction in clinical appearance on a 10-point scale

Time frame: 6-8 weeks

Secondary Outcomes

Skin reflectance measurement to assess degree of redness

Time frame: 6-8 weeks

Skin reflectance to assess degree of pigmentation

Time frame: 6-8 weeks

Data from ClinicalTrials.gov

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