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

Phase I Combined Use of Pulsed Dye Laser and Rapamycin

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00800722
Enrollment
21
Registered
2008-12-02
Start date
2008-11-30
Completion date
2014-06-30
Last updated
2022-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Port Wine Stain

Keywords

hypervascular anomalies

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.

Interventions

DRUGRapamycin Treatment of Port Wine Stain

Treatment of Port Wine Stain

Sponsors

Pfizer
CollaboratorINDUSTRY
Beckman Laser Institute University of California Irvine
CollaboratorOTHER
University of California, Irvine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
improve port wine stain (PWS) therapeutic outcome8 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026