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Completed

NCT Number: NCT00800722

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

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.

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Key information

Conditions

Port Wine Stain Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Port-Wine Stain Skin Abnormalities Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beckman Laser Institute Medical clinic

Irvine, California, 92612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rapamycin Treatment of Port Wine Stain

Drug

Treatment of Port Wine Stain

Other names: Treatment of Port Wine Stain

Primary outcomes

  1. improve port wine stain (PWS) therapeutic outcome

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

  • Beckman Laser Institute University of California Irvine
  • Pfizer

Registry information

Official study title

Phase I Combined Use of Pulsed Dye Laser and Rapamycin

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Dec 2, 2008
Registry last updated
Nov 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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