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

Phase 1

Completed

• Conditions: Port Wine Stain
• Interventions: Drug: Rapamycin Treatment of Port Wine Stain

• Registration Number: NCT00800722
• Lead Sponsor: University of California, Irvine

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.

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-12-01
• Study First Submitted QC: 2008-12-01
• Study First Posted: 2008-12-02
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-28
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment of Port Wine Stain	Rapamycin Treatment of Port Wine Stain	Rapamycin Treatment of Port Wine Stain

Primary Outcome Measures

Name	Time	Method
improve port wine stain (PWS) therapeutic outcome	8 weeks

Trial Locations

Locations (1)

Beckman Laser Institute Medical clinic; 🇺🇸 Irvine, California, United States