Treatment of Nevus Flammeus With Alexandrite Laser
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 Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Treatment of Nevus Flammeus With Alexandrite Laser|
- Reduction in clinical appearance on a 10-point scale [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]
- Skin reflectance measurement to assess degree of redness [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]
- Skin reflectance to assess degree of pigmentation [ Time Frame: 6-8 weeks ] [ Designated as safety issue: Yes ]
- Clinical assessment of pigmentation [ Time Frame: 6-8 weeks ] [ Designated as safety issue: Yes ]
- Clinical assessment of scar tissue formation [ Time Frame: 6-8 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2013|
|Study Completion Date:||December 2014|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
|Experimental: Alexandrite laser treatment||
Procedure: Alexandrite laser
3 different alexandrite laser settings are used in respectively 3 different treatment areas and compared with a non-treated control area.
Other Name: Candela Gentle Max
Please refer to this study by its ClinicalTrials.gov identifier: NCT01968681
|Copenhagen, Denmark, 2400|
|Principal Investigator:||Merete Haedersdal, Professor||Bispebjerg Hospital|