A Randomized Trial to Study Combined Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain Birthmarks.

This study has been completed.
Sponsor:
Collaborators:
Pfizer
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00800722
First received: December 1, 2008
Last updated: September 22, 2015
Last verified: September 2015
  Purpose
The purpose of this study is to improve port wine stain therapeutic outcome in response to laser therapy. The researchers want to determine whether the combined use of pulsed dye laser therapy and rapamycin will improve PWS therapeutic outcome.

Condition Intervention Phase
Port Wine Stain
Drug: Rapamycin Treatment of 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: Phase I Combined Use of Pulsed Dye Laser and Rapamycin

Resource links provided by NLM:


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

Primary Outcome Measures:
  • improve port wine stain (PWS) therapeutic outcome [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 21
Study Start Date: November 2008
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment of Port Wine Stain
Rapamycin Treatment of Port Wine Stain
Drug: Rapamycin Treatment of Port Wine Stain
Treatment of Port Wine Stain
Other Name: Treatment of Port Wine Stain

Detailed Description:
The researchers want to combined use of pulsed dye laser to induce port wine stain blood vessel injury, and rapamycin directly inhibits the proliferation of vascular endothelial cells driven by vascular endothelial growth factor which preventing port wine stain angiogenesis and recanalization, to improve port wine stain lesion blanching.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • port wine stain birthmarks suitable for comparison testing.

Exclusion Criteria:

  • Pregnancy.
  • Abnormal blood hematology or chemistry blood tests or urine analysis.
  • History of cancer, History of high cholesterol, lipids or liver disease
  • Allergy to macrolide drugs (e.g., erythromycin).
  • Any therapy within the previous two months to the proposed PWS treatment sites.
  • Concurrent use of known photosensitizing drugs,immunosuppressive drugs or systemic steroids,antifungals, antiepileptics, HIV protease inhibitors, cimetidine, cisapride, clarithromycin, dannzol, diltiazem, erythromycin, metoclopramide, rifabutin, rifampin, rifapentine, troleandomycin, or verapamil.
  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: NCT00800722

Locations
United States, California
Beckman Laser Institute Medical clinic
Irvine, California, United States, 92612
Sponsors and Collaborators
University of California, Irvine
Pfizer
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: John S Nelson, M.D,PhD Beckman Laser Institute University of California Irvine
  More Information

Responsible Party: Beckman Laser Institute and Medical Center, J S Nelson, M.D., Ph.D.,Professor of Surgery and Biomedical Engineering, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00800722     History of Changes
Other Study ID Numbers: NIH/LAMMP6383 
Study First Received: December 1, 2008
Last Updated: September 22, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Irvine:
hypervascular anomalies

Additional relevant MeSH terms:
Port-Wine Stain
Hemangioma, Capillary
Vascular Malformations
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Cardiovascular Abnormalities
Cardiovascular Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2016