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Treatment of Nevus Flammeus With Alexandrite Laser

B

Bispebjerg Hospital

Status

Completed

Conditions

Nevus Flammeus

Treatments

Procedure: Alexandrite laser

Study type

Interventional

Funder types

Other

Identifiers

NCT01968681
H-4-2013-066

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

10+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

Single Blind

19 participants in 1 patient group

Alexandrite laser treatment
Experimental group
Treatment:
Procedure: Alexandrite laser

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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