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Treatment of Nevus Flammeus With Alexandrite Laser

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ClinicalTrials.gov Identifier: NCT01968681
Recruitment Status : Completed
First Posted : October 24, 2013
Last Update Posted : February 24, 2015
Sponsor:
Information provided by (Responsible Party):
Merete Haedersdal, Bispebjerg Hospital

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.


Condition or disease Intervention/treatment Phase
Nevus Flammeus Procedure: Alexandrite laser Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Nevus Flammeus With Alexandrite Laser
Study Start Date : September 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birthmarks Moles
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Reduction in clinical appearance on a 10-point scale [ Time Frame: 6-8 weeks ]

Secondary Outcome Measures :
  1. Skin reflectance measurement to assess degree of redness [ Time Frame: 6-8 weeks ]
  2. Skin reflectance to assess degree of pigmentation [ Time Frame: 6-8 weeks ]

Other Outcome Measures:
  1. Clinical assessment of pigmentation [ Time Frame: 6-8 weeks ]
  2. Clinical assessment of scar tissue formation [ Time Frame: 6-8 weeks ]


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Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01968681


Locations
Denmark
Bispebjerg Hospital
Copenhagen, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
Principal Investigator: Merete Haedersdal, Professor Bispebjerg Hospital

Responsible Party: Merete Haedersdal, Professor, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01968681     History of Changes
Other Study ID Numbers: H-4-2013-066
First Posted: October 24, 2013    Key Record Dates
Last Update Posted: February 24, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Nevus
Port-Wine Stain
Nevi and Melanomas
Neoplasms by Histologic Type
Neoplasms
Skin Abnormalities
Congenital Abnormalities
Skin Diseases