Combined Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain Birthmarks

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00830466
First received: January 27, 2009
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Port Wine Stain
Drug: Laser and rapamycin versus laser alone
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combined Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain Birthmarks

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Improved port wine stain fading/blanching after laser treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 40
Study Start Date: July 2014
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laser and rapamycin versus laser alone
Laser and rapamycin versus laser alone
Drug: Laser and rapamycin versus laser alone
Laser and rapamycin versus laser alone
Other Name: Laser and rapamycin versus laser alone

Detailed Description:

The study will offer two different approaches to the treatment of port wine stain birthmarks.

Study Group Number 1: Port wine stain treated by the pulsed dye laser alone, which is the current standard of care: 20 subjects.

Study Group Number 2: Port wine stain treated by combined pulsed dye laser and rapamycin: 20 subjects.

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. Twenty subjects will have their entire port wine stain birthmark treated by pulsed dye laser alone. Twenty subjects will have their entire port wine stain birthmark treated by combined pulsed dye laser and rapamycin, which is a drug that prevents the formation of blood vessels in the skin. Safety will be evaluated by searching for any local effects such as injury to the skin or systemic effects such as abnormal blood and/or urine studies. Efficacy will be determined by objectively measuring and comparing the port wine stain fading/blanching responses for the two study groups.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00830466

Locations
United States, California
Beckman Laser Institute and Medical Clinic
Irvine, California, United States, 92612
Sponsors and Collaborators
Montana Compton
Investigators
Principal Investigator: J. Stuart Nelson, M.D.,Ph.D. Beckman Laser Institute and Medical Clinic, University of California Irvine
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00830466     History of Changes
Other Study ID Numbers: LAMMP/443800
Study First Received: January 27, 2009
Last Updated: July 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Irvine:
port wine stain

Additional relevant MeSH terms:
Port-Wine Stain
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014