Treatment of Nevus Flammeus With Alexandrite Laser

Nevus Flammeus Clinical Trial

Official title:

Treatment of Nevus Flammeus With Alexandrite Laser

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01968681
• Other study ID #: H-4-2013-066
• Status: Completed
• Phase: N/A
• First received: October 21, 2013
• Last updated: February 22, 2015
• Start date: September 2013
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nevus
• Nevus Flammeus
• Port-Wine Stain

Intervention

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

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical assessment of pigmentation		6-8 weeks	Yes
Other	Clinical assessment of scar tissue formation		6-8 weeks	Yes
Primary	Reduction in clinical appearance on a 10-point scale		6-8 weeks	No
Secondary	Skin reflectance measurement to assess degree of redness		6-8 weeks	No
Secondary	Skin reflectance to assess degree of pigmentation		6-8 weeks	Yes