Expired Study
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Irvine, California 92612


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.


Study summary:

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.


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.


Study is Available At:


Original ID:

NIH/LAMMP-2008-6383


NCT ID:

NCT00830466


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

N/A


Minimum Age:

13 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, Irvine


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

22


Enrollment Type:

Actual


Overall Contact Information

Official Name:J. Stuart Nelson, M.D.,Ph.D.
Principal Investigator
Beckman Laser Institute and Medical Clinic, University of California Irvine

Study Dates

Start Date:December 2008
Completion Date:January 2016
Completion Type:Actual
Primary Completion Date:January 2016
Primary Completion Type:Actual
Verification Date:February 2017
Last Changed Date:February 8, 2017
First Received Date:January 27, 2009

Study Outcomes

Outcome Type:Primary Outcome
Measure:Improved port wine stain fading/blanching after laser treatment
Time Frame:24 weeks
Safety Issues:False
Description: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

Study Interventions

Intervention Type:Drug
Name:Laser and rapamycin versus laser alone
Description:Laser and rapamycin versus laser alone
Arm Name:Laser and rapamycin versus laser alone

Study Arms

Study Arm Type:Experimental
Arm Name:Laser and rapamycin versus laser alone
Description:Laser and rapamycin versus laser alone

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, Irvine
Agency Class:Other
Agency Type:Collaborator
Agency Name:Beckman Laser Institute University of California Irvine

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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