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

NCT00830466 | Completed Phase 1

• 1 other identifier: 20086383
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The researchers want to collect data on safety and efficacy of combined pulsed dye laser and rapamycin to improve fading/blanching of port wine stain birthmarks as compared to pulsed dye laser alone, which is the current standard of care. This single center pilot and feasibility study will have a target enrollment of 40 port wine stain subjects at the Beckman Laser Institute and Medical Clinic, University of California, Irvine.

Conditions

Port Wine Stain

Keywords

port wine stain

Outcome Measures

Primary Outcomes (1)

• Improved port wine stain fading/blanching after laser treatment

  Efficacy will be determined by objectively measuring and comparing the port wine stain fading/blanching responses for subjects treated with combined pulsed dye laser and rapamycin versus pulsed dye laser alone

  24 weeks

Study Arms (1)

Laser and rapamycin versus laser alone

EXPERIMENTAL

Laser and rapamycin versus laser alone

Drug: Laser and rapamycin versus laser alone

Interventions

Laser and rapamycin versus laser alone DRUG

Laser and rapamycin versus laser alone

Laser and rapamycin versus laser alone

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Port wine stain suitable for comparison testing.
• Age \> 13 years of age or older; minor will be accompanied in the room by parents or guardians during laser treatment.
• Apparent good health as documented by medical history.
• Ability to understand and carry out subject instructions.
• Women of childbearing potential must have a negative urinary pregnancy test prior to being started on rapamycin.
• Women of child bearing potential must agree to use a medically acceptable method of contraception throughout the study and for 3 months following discontinuation of rapamycin.

You may not qualify if:

• Inability to understand and carry out instructions.
• Pregnancy.
• Abnormal blood or urine tests
• 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 port wine stain treatment sites.
• Current participation in any other investigational drug evaluation.
• Concurrent use of known photosensitizing drugs.
• Concurrent use of immunosuppressive drugs or steroids.
• Concurrent use of any of the following medications: antifungals, antiepileptics, protease inhibitors, cimetidine, cisapride, clarithromycin, dannzol, diltiazem, erythromycin, metoclopramide, rifabutin, rifampin, rifapetine, troleandomycin, or verapamil.

Sponsors & Collaborators

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

Study Sites (1)

Beckman Laser Institute and Medical Clinic

Irvine, California, 92612, United States

Location

MeSH Terms

Conditions

Port-Wine Stain

Interventions

Lasers

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• J. Stuart Nelson, M.D.,Ph.D.

  Beckman Laser Institute and Medical Clinic, 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: January 27, 2009
• First Posted: January 28, 2009
• Study Start: December 1, 2008
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: November 1, 2022

Record last verified: 2022-10

Locations

US (1)