Treatment of Nevus Flammeus With Alexandrite Laser
Not Applicable
Completed
- Conditions
- Nevus Flammeus
- Interventions
- Procedure: Alexandrite laser
- Registration Number
- NCT01968681
- Lead Sponsor
- Bispebjerg Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Alexandrite laser treatment Alexandrite laser -
- Primary Outcome Measures
Name Time Method Reduction in clinical appearance on a 10-point scale 6-8 weeks
- Secondary Outcome Measures
Name Time Method Skin reflectance measurement to assess degree of redness 6-8 weeks Skin reflectance to assess degree of pigmentation 6-8 weeks
Trial Locations
- Locations (1)
Bispebjerg Hospital
🇩🇰Copenhagen, Denmark