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

NCT ID: NCT00800722

Last Updated: 2022-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2014-06-30

Brief Summary

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.

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.

Conditions

Port Wine Stain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment of Port Wine Stain

Rapamycin Treatment of Port Wine Stain

Group Type: EXPERIMENTAL

Rapamycin Treatment of Port Wine Stain

Intervention Type: DRUG

Treatment of Port Wine Stain

Interventions

Rapamycin Treatment of Port Wine Stain

Treatment of Port Wine Stain

Intervention Type: DRUG

Other Intervention Names

Treatment of Port Wine Stain

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Beckman Laser Institute University of California Irvine

OTHER

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Beckman Laser Institute and Medical Center

J S Nelson, M.D., Ph.D.,Professor of Surgery and Biomedical Engineering

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John S Nelson, M.D,PhD

Role: PRINCIPAL_INVESTIGATOR

Beckman Laser Institute University of California Irvine

Locations

Beckman Laser Institute Medical clinic

Irvine, California, United States

Countries

United States

Other Identifiers

20086383.

Identifier Type: -

Identifier Source: org_study_id