Treatment of Nevus Flammeus With Alexandrite Laser
1 other identifier
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 21, 2013
CompletedFirst Posted
Study publicly available on registry
October 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFebruary 24, 2015
February 1, 2015
1.2 years
October 21, 2013
February 22, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction in clinical appearance on a 10-point scale
6-8 weeks
Secondary Outcomes (2)
Skin reflectance measurement to assess degree of redness
6-8 weeks
Skin reflectance to assess degree of pigmentation
6-8 weeks
Other Outcomes (2)
Clinical assessment of pigmentation
6-8 weeks
Clinical assessment of scar tissue formation
6-8 weeks
Study Arms (1)
Alexandrite laser treatment
EXPERIMENTALInterventions
3 different alexandrite laser settings are used in respectively 3 different treatment areas and compared with a non-treated control area.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bispebjerg Hospital
Copenhagen, 2400, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Merete Haedersdal, Professor
Bispebjerg Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 21, 2013
First Posted
October 24, 2013
Study Start
September 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
February 24, 2015
Record last verified: 2015-02