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

January 14, 2013
June 2, 2014
December 2012
December 2015   (final data collection date for primary outcome measure)
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 ]
Laser Treatment of port wine stain [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
Laser Treatment of port wine stain
Complete list of historical versions of study NCT01775722 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment
Combined Bipolar Radiofrequency and Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Port-Wine Stain
Device: port wine stain
port wine stain
Other Name: candela-Laser
No Intervention: port wine stain
port wine stain
Intervention: Device: port wine stain
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
12 Years and older
No
Contact: Montana Compton, RN 949-824-9265 mocomton@uci.edu
United States
 
NCT01775722
NIH-Arthritis-RO1
Yes
Montana Compton, University of California, Irvine
Montana Compton
Candela Corporation
Principal Investigator: J. Stuart Nelson, M.D., Ph.D. Beckman Laser Institute, UCI
University of California, Irvine
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP