Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of California, Irvine
Sponsor:
Collaborator:
Candela Corporation
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01775722
First received: January 14, 2013
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Port-Wine Stain
Device: port wine stain
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combined Bipolar Radiofrequency and Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • combined radiofrequency electrical energy with pulsed dye laser will improve Port wine stain outcome [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: port wine stain
port wine stain
Device: port wine stain
port wine stain
Other Name: candela-Laser

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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: NCT01775722

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

Locations
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
Montana Compton
Candela Corporation
Investigators
Principal Investigator: J. Stuart Nelson, M.D., Ph.D. Beckman Laser Institute, UCI
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01775722     History of Changes
Other Study ID Numbers: NIH-Arthritis-RO1
Study First Received: January 14, 2013
Last Updated: June 2, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 23, 2014