Combined Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain Birthmarks

This study is currently recruiting participants.
Verified December 2013 by University of California, Irvine
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00830466
First received: January 27, 2009
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

The purpose of this research study is to improve port wine stain treatment in response to laser therapy.


Condition Intervention Phase
Port Wine Stain
Drug: 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 Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain Birthmarks

Resource links provided by NLM:


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

Primary Outcome Measures:
  • improve PWS lesion blanching [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: March 2009
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: port wine stain
Port Wine Stain
Drug: Port Wine Stain
Port Wine Stain
Other Name: Port Wine Stain

Detailed Description:

The researcher want to konw whether or not the combined treatment of pulsed dye laser and oral rapamycin will improve port wine stain fading.

  Eligibility

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

Inclusion Criteria:

  • PWS suitable for comparison testing;
  • 12 years of age or older

Exclusion Criteria:

  • Pregnancy
  • Abnormal blood test or urine tests
  • History of cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00830466

Contacts
Contact: Stuart J Nelson, MD,PhD 949-824-7997 jsnelson@uci.edu
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   
Contact: Montana Compton, RN    949-824-9265    mocomton@uci.edu   
Sub-Investigator: Wangcun Jia, PhD         
Sponsors and Collaborators
Montana Compton
Investigators
Principal Investigator: Stuart J Nelson, M.D,PhD UCI, Beckman Laser Institute Medical Clinic
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00830466     History of Changes
Other Study ID Numbers: NIH /NIAMS-RO1 AR59244, K24AR047551
Study First Received: January 27, 2009
Last Updated: December 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Irvine:
port wine stain

Additional relevant MeSH terms:
Port-Wine Stain
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
Sirolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 16, 2014