Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Treatment of Nevus Flammeus With Alexandrite Laser

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merete Haedersdal, Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT01968681
First received: October 21, 2013
Last updated: February 22, 2015
Last verified: February 2015
  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: 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

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Reduction in clinical appearance on a 10-point scale [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01968681

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

No publications provided

Responsible Party: Merete Haedersdal, Professor, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01968681     History of Changes
Other Study ID Numbers: H-4-2013-066
Study First Received: October 21, 2013
Last Updated: February 22, 2015
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Port-Wine Stain
Congenital Abnormalities
Skin Abnormalities
Skin Diseases

ClinicalTrials.gov processed this record on February 27, 2015