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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Beckman Laser Institute University of California Irvine
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00800722
First received: December 1, 2008
Last updated: December 28, 2012
Last verified: December 2012
History of Changes
  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: Rampamycin 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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 25
Study Start Date: November 2008
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Treatment of Port Wine Stain
Rampamycin Treatment of Port Wine Stain
 Drug: Rampamycin 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:   16 Years and older
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, rifapetine, troleandomycin, or verapamil.
  Contacts and Locations
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
Montana Compton
Beckman Laser Institute University of California Irvine
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: John S Nelson, M.D,PhD Beckman Laser Institute University of California Irvine
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00800722     History of Changes
Other Study ID Numbers: NIH EB-02495-05, LAMMP
Study First Received: December 1, 2008
Last Updated: December 28, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Irvine:
hypervascular anomalies

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 May 19, 2013