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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00830466
First received: January 27, 2009
Last updated: October 28, 2011
Last verified: October 2011
History of Changes
  Purpose

The purpose of this research study is to improve port wine stain treatment in response to laser therapy.


Condition Intervention Phase
Port Wine Stain
 Drug: rapamycin
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combined Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain Birthmarks

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • improve PWS lesion blanching [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: March 2009
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: port wine stain
improve port wine stain
 Drug: rapamycin
rapamycin (oral or topical)
Other Name: sirolimus

Detailed Description:

The researcher want to konw whether or not the combined treatment of pulsed dye laser and oral rapamycin will improve port wine stain fading.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PWS suitable for comparison testing;
  • 12 years of age or older

Exclusion Criteria:

  • Pregnancy
  • Abnormal blood test or urine tests
  • History of cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00830466

Locations
United States, California
Beckman Laser Institute Medical clinic
Irvine, California, United States, 92612
Sponsors and Collaborators
Montana Compton
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Stuart J Nelson, M.D,PhD UCI, Beckman Laser Institute Medical Clinic
  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: NIH /NIAMS-RO1 AR59244, K24AR047551
Study First Received: January 27, 2009
Last Updated: October 28, 2011
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
Antibiotics, Antineoplastic
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on October 18, 2012