Treatment of Nevus Flammeus With Alexandrite Laser

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01968681

Enrollment

Registered

2013-10-24

Start date

2013-09-30

Completion date

2014-12-31

Last updated

2015-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nevus Flammeus

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.

Interventions

PROCEDUREAlexandrite laser

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

10 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Reduction in clinical appearance on a 10-point scale	6-8 weeks

Secondary

Measure	Time frame
Skin reflectance measurement to assess degree of redness	6-8 weeks
Skin reflectance to assess degree of pigmentation	6-8 weeks

Other

Measure	Time frame
Clinical assessment of pigmentation	6-8 weeks
Clinical assessment of scar tissue formation	6-8 weeks

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026