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Trial record 8 of 32 for:    Stain | "Parkes Weber syndrome" OR "Vascular Malformations"

Novel Treatment for Port Wine Stain Birthmarks

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ClinicalTrials.gov Identifier: NCT01924273
Recruitment Status : Recruiting
First Posted : August 16, 2013
Last Update Posted : February 13, 2018
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine

Brief Summary:
Port wine stains Birthmark are congenital, progressive vascular malformations of the skin that occur in approximately 0.7% of newborns. Approximately 1.5 million individuals in the United States and 32 million people worldwide have Port wine stains birthmarks. Two-thirds of these malformations occur on the face. Personality development of virtually all patients is adversely affected as a result of the negative reaction of others to a "marked" person. Detailed studies have documented lower self-esteem and difficulties with interpersonal interactions in Port wine stains patients. Port wine stains are initially flat and red, but with time, they tend to darken to purple and become thickened as vascular nodules develop. This thickening occurs in approximately two-thirds of lesions and further disfigures the facial features of many patients.

Condition or disease Intervention/treatment Phase
Port-Wine Stain Drug: Talaporfin sodium Phase 1

Detailed Description:

Pulsed dye laser is currently the standard of care treatment for Port wine stains. Researchers at University of California Irvine at Beckman Laser Institute Medical Clinic can use Photodynamic therapy, another treatment option for Port wine stains. Photodynamic therapy involves light activation of a photosensitizer (a drug that is responsive to light or radiant energy). Because the photosensitizer can be localized to a desired portion of the Port wine stain, Photodynamic therapy creates an opportunity for targeted destruction of Port wine stains.

Researchers will use a photosensitizer medication called Talaporfin sodium, an intravenously administered investigational photosensitizer, being evaluated for multiple clinical indications. Photodynamic therapy with talaporfin sodium has been investigated for many different conditions, and can be used for treatment for Port wine stains. Photosensitivity precaution instructions will be provided, including appropriate photo protective clothing, protective hat and sunglasses that wrap around the temples to help minimize lateral sun light exposure when traveling home following discharge from the study site.

For efficacy, evaluated study variable will be Port wine stain blanching, and the researchers can use diffuse reflectance imaging chromametry, Laser Speckle Imaging and Spatial Frequency Domain Imaging to measure the change of Port wine stain blanching. The maximum power of the Laser Speckle Imaging and Spatial Frequency Domain Imaging light source is 10-50 mW, which is comparable to halogen-bulb household flashlights. Efficacy will be evaluated based on comparison of pre-treatment visit and post treatment day 1, week 1, week 4, and week 12 measurements.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Novel Treatment for Port Wine Stain Birthmarks
Study Start Date : June 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Port Wine Stain Birthmarks
Combined Photodynamic/Pulsed Dye Laser Therapy/Talaporfin sodium
Drug: Talaporfin sodium
Combined Photodynamic/Pulsed Dye Laser Therapy/Talaporfin sodium
Other Name: Combined Laser treatment andTalaporfin sodium




Primary Outcome Measures :
  1. Port wine stain blanching [ Time Frame: up to 12 weeks ]
    The outcome measure will be PWS blanching as assessed by Diffuse Reflectance Imaging/Laser Speckle Imaging/Spatial Frequency Domain Imaging.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male/Female 18 years and older
  • Have Port Wine Stain Birthmarks non-facial

Exclusion Criteria:

  • Under 18 years of age
  • No Port Wine Stain Birthmarks
  • pregnant/breast feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01924273


Contacts
Contact: Montana Compton, RN 949.824.9265 mocomton@uci.edu

Locations
United States, California
Beckman Laser Institute Recruiting
Irvine, California, United States, 92612
Contact: Montana Compton, RN    949-824-9265    mocomton@uci.edu   
Sub-Investigator: Montana Compton, RN         
Sub-Investigator: Bernard Choi, PhD         
Sub-Investigator: Wesley Moy, PhD         
Sub-Investigator: Bruce Yang, PhD         
Sub-Investigator: Brent Martin, MS4         
Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: Kristen Kelly, MD Beckman Laser Institute

Responsible Party: Beckman Laser Institute and Medical Center, Kristen Kelly M.D.,Professor Departments of Dermatology and Surgery, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01924273     History of Changes
Other Study ID Numbers: NIH/LAMMP-2013-9337
First Posted: August 16, 2013    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018

Keywords provided by Beckman Laser Institute and Medical Center, University of California, Irvine:
Port Wine Stain Birthmarks

Additional relevant MeSH terms:
Port-Wine Stain
Vascular Malformations
Hemangioma, Capillary
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Cardiovascular Abnormalities
Cardiovascular Diseases
Talaporfin
Antineoplastic Agents
Photosensitizing Agents
Dermatologic Agents