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Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment

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ClinicalTrials.gov Identifier: NCT01775722
Recruitment Status : Recruiting
First Posted : January 25, 2013
Last Update Posted : August 6, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
Port wine stain Birthmark is a congenital, progressive vascular malformation of human skin. However, even though the pulsed dye laser is considered as the treatment of choice for Port wine stain Birthmark the degree of fading can remain variable and unpredictable after laser treatment.

Condition or disease Intervention/treatment Phase
Port-Wine Stain Device: port wine stain Phase 1

Detailed Description:
The researcher want to use the combination of radiofrequency electrical energy with pulsed dye laser light energy which can improve therapeutic outcome of Port wine stain Birthmark. This investigational device is essentially a combination of two commercially available systems cleared for marketing (K044351 and K052324) provided by Candela Laser Corporation.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Bipolar Radiofrequency and Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks
Study Start Date : December 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arms and Interventions

Arm Intervention/treatment
No Intervention: port wine stain
port wine stain
Device: port wine stain
port wine stain
Other Name: candela-Laser

Outcome Measures

Primary Outcome Measures :
  1. combined radiofrequency electrical energy with pulsed dye laser will improve Port wine stain outcome [ Time Frame: up to 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Port Wine Stain suitable for comparison testing
  2. Age > 12 years of age; minor will be accompanied in the room by parents or guardians during laser treatment
  3. Apparent good health as documented by medical history
  4. Ability to understand and carry out subject instructions

Exclusion Criteria:

  1. History of photodermatoses or skin cancer
  2. Any therapy within the previous two months to the proposed port wine stain treatment sites
  3. Current participation in any other investigational drug or device evaluation
  4. Concurrent use of known photosensitizing drugs
  5. Inability to understand and carry out instructions
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): NCT01775722

Contact: Montana Compton, RN 949-824-9265 mocomton@uci.edu

United States, California
Beckman Laser Institute Medical Clinic Recruiting
Irvine, California, United States, 92612
Contact: Montana Compton, RN    949-824-9265    mocomton@uci.edu   
Principal Investigator: John Stuart Nelson, MD, PhD         
Sub-Investigator: Wangcun Jia, PhD         
Sub-Investigator: Montana Compton, RN         
Sponsors and Collaborators
University of California, Irvine
Candela Corporation
Beckman Laser Institute University of California Irvine
Principal Investigator: J. Stuart Nelson, M.D., Ph.D. Beckman Laser Institute, UCI
More Information

Responsible Party: Beckman Laser Institute and Medical Center, J.S.Nelson, MD,PhD,Professor of Surgery and Biomedical Engineering, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01775722     History of Changes
Other Study ID Numbers: NIH/LAMMP-2012-9092
First Posted: January 25, 2013    Key Record Dates
Last Update Posted: August 6, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Port-Wine Stain
Hemangioma, Capillary
Vascular Malformations
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Cardiovascular Abnormalities
Cardiovascular Diseases