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

This study is enrolling participants by invitation only.

First Received: January 27, 2009 Last Updated: March 17, 2009 History of Changes

Sponsors and Collaborators:	University of California, Irvine Wyeth
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00830466

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 I

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Combined Pulsed Dye Laser and Rapamycin Treatment of Port Wine Stain Birthmarks

Resource links provided by NLM:

Drug Information available for: Sirolimus

U.S. FDA Resources

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

Primary Outcome Measures:

improve port wine stain [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	25
Study Start Date:	March 2009
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
port wine stain: Experimental improve port wine stain	Drug: rapamycin rapamycin 2 mg

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:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

PWS suitable for comparison testing;
16 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

University of California, Irvine

Wyeth

Investigators

Principal Investigator:

Stuart J Nelson, M.D,PhD

UCI, Beckman Laser Institute Medical Clinic

More Information

No publications provided

Responsible Party:	UCI, Beckman Laser Institute Medical Clinic ( J Stuart Nelson, MD.PhD )
Study ID Numbers:	NIH NIBIB EB-02495-05, Wyeth-Ayerst
Study First Received:	January 27, 2009
Last Updated:	March 17, 2009
ClinicalTrials.gov Identifier:	NCT00830466 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, Irvine:

port wine stain

Study placed in the following topic categories:

Sirolimus
Anti-Infective Agents
Anti-Bacterial Agents
Immunologic Factors
Skin Diseases
Antifungal Agents

Nevi Flammei, Familial Multiple
Port-Wine Stain
Skin Abnormalities
Congenital Abnormalities
Immunosuppressive Agents

Additional relevant MeSH terms:

Sirolimus
Anti-Infective Agents
Skin Diseases
Immunologic Factors
Antineoplastic Agents
Port-Wine Stain
Physiological Effects of Drugs
Skin Abnormalities

Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions
Anti-Bacterial Agents
Therapeutic Uses
Antifungal Agents
Congenital Abnormalities

ClinicalTrials.gov processed this record on September 03, 2009