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

NCT00800722 | Completed Phase 1 DMC

• 1 other identifier: 20086383.
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Port Wine Stain

Keywords

hypervascular anomalies

Outcome Measures

Primary Outcomes (1)

• improve port wine stain (PWS) therapeutic outcome

  8 weeks

Study Arms (1)

Treatment of Port Wine Stain

EXPERIMENTAL

Rapamycin Treatment of Port Wine Stain

Drug: Rapamycin Treatment of Port Wine Stain

Interventions

Rapamycin Treatment of Port Wine Stain DRUG

Treatment of Port Wine Stain

Also known as: Treatment of Port Wine Stain

Treatment of Port Wine Stain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• port wine stain birthmarks suitable for comparison testing.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Irvine: lead
• Pfizer: collaborator
• Beckman Laser Institute University of California Irvine: collaborator

Study Sites (1)

Beckman Laser Institute Medical clinic

Irvine, California, 92612, United States

Location

MeSH Terms

Conditions

Port-Wine Stain

Condition Hierarchy (Ancestors)

Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• John S Nelson, M.D,PhD

  Beckman Laser Institute University of California Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: J S Nelson, M.D., Ph.D.,Professor of Surgery and Biomedical Engineering

Study Record Dates

• First Submitted: December 1, 2008
• First Posted: December 2, 2008
• Study Start: November 1, 2008
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: November 1, 2022

Record last verified: 2022-10

Locations

US (1)