Back to resultsTreatment of Nevus Flammeus With Alexandrite Laser
Primary Purpose
Nevus Flammeus
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Alexandrite laser
Sponsored by
About this trial
This is an interventional treatment trial for Nevus Flammeus
Eligibility Criteria
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
Sites / Locations
- Bispebjerg Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Alexandrite laser treatment
Arm Description
Outcomes
Primary Outcome Measures
Reduction in clinical appearance on a 10-point scale
Secondary Outcome Measures
Skin reflectance measurement to assess degree of redness
Skin reflectance to assess degree of pigmentation
Full Information
NCT ID
NCT01968681
First Posted
October 21, 2013
Last Updated
February 22, 2015
Sponsor
Bispebjerg Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01968681
Brief Title
Treatment of Nevus Flammeus With Alexandrite Laser
Official Title
Treatment of Nevus Flammeus With Alexandrite Laser
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nevus Flammeus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alexandrite laser treatment
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Alexandrite laser
Other Intervention Name(s)
Candela Gentle Max
Intervention Description
3 different alexandrite laser settings are used in respectively 3 different treatment areas and compared with a non-treated control area.
Primary Outcome Measure Information:
Title
Reduction in clinical appearance on a 10-point scale
Time Frame
6-8 weeks
Secondary Outcome Measure Information:
Title
Skin reflectance measurement to assess degree of redness
Time Frame
6-8 weeks
Title
Skin reflectance to assess degree of pigmentation
Time Frame
6-8 weeks
Other Pre-specified Outcome Measures:
Title
Clinical assessment of pigmentation
Time Frame
6-8 weeks
Title
Clinical assessment of scar tissue formation
Time Frame
6-8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merete Haedersdal, Professor
Organizational Affiliation
Bispebjerg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Treatment of Nevus Flammeus With Alexandrite Laser
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