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

Port Wine Stain Clinical Trial

Official title:

Phase I Combined Use of Pulsed Dye Laser and Rapamycin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00800722
• Other study ID #: 20086383.
• Status: Completed
• Phase: Phase 1
• Start date: November 2008
• Est. completion date: June 2014

Study information

• Verified date: October 2022
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemangioma, Capillary
• Port Wine Stain
• Port-Wine Stain

Intervention

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

Locations

Country	Name	City	State
United States	Beckman Laser Institute Medical clinic	Irvine	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Irvine	Beckman Laser Institute University of California Irvine, Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improve port wine stain (PWS) therapeutic outcome		8 weeks