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Treatment of Nevus Flammeus With Alexandrite Laser

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01968681
First Posted: October 24, 2013
Last Update Posted: February 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merete Haedersdal, Bispebjerg Hospital
  Purpose

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 Intervention
Nevus Flammeus Procedure: Alexandrite laser

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Nevus Flammeus With Alexandrite Laser

Resource links provided by NLM:


Further study details as provided by Merete Haedersdal, Bispebjerg Hospital:

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

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

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

Enrollment: 19
Study Start Date: September 2013
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: Merete Haedersdal, Professor, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01968681     History of Changes
Other Study ID Numbers: H-4-2013-066
First Submitted: October 21, 2013
First Posted: October 24, 2013
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