Novel Treatment for Port Wine Stain Birthmarks

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01924273
Study type	Interventional
Source	University of California, Irvine
Contact
Status	Completed
Phase	Phase 1
Start date	June 2013
Completion date	July 3, 2017

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT04336163` - Skin Imaging to Inform Laser Treatments	N/A
Not yet recruiting	`NCT04536740` - Effect of Pulsed Dye Laser on Photodynamic Therapy of Port-Wine Stains	N/A
Completed	`NCT00365118` - Treatment of Naevus Flammeus Using Intense Pulsed Light and Pulsed Dye Laser	N/A
Completed	`NCT04106258` - A Pilot Study of Hemoporfin PDT in Children(2-7 Years Old) With Port-wine Stain	Phase 4
Recruiting	`NCT05841628` - Tolerability of 532 nm Laser Treatment of Port Wine Stains	N/A
Withdrawn	`NCT00667472` - Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks	Phase 1
Terminated	`NCT02214706` - Treatment of Port Wine Stains Using Pulsed Dye Laser, Erbium Yag Laser and Topical Sirolimus	N/A
Completed	`NCT00540917` - Measurement Skin Temperature During Pulsed Laser Exposure	Phase 2
Suspended	`NCT04103164` - Pilot Study to Evaluate the Effect of Multiple Passes on Port Wine Stain Treatments With the Cutera Excel V™ Laser.	N/A
Completed	`NCT04999618` - A New Approach in Laser Surgery Using the Regenerative Solution in Children Diagnosed With Vascular Pathology	Phase 4
Recruiting	`NCT05771311` - KTP Laser vs Pulsed Dye Laser for Port-Wine Stains	N/A
Completed	`NCT01775722` - Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment	N/A
Completed	`NCT01774552` - Evaluate the Port-wine Stain Birthmark Treatment Before and After Pulsed Dye Laser Treatment
Not yet recruiting	`NCT05171894` - A Study to Evaluate Efficacy and Safety of Light Dose in Subjects With PWB Treated With Hemoporfin + PDT	Phase 2
Completed	`NCT03181984` - Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain	Phase 4
Completed	`NCT03125057` - A Pilot Study of Hemoporfin PDT in Children With Port-wine Stain	Phase 4
Completed	`NCT02051101` - Pathogenic Mechanisms of Port Wine Stain and Repository of Port Wine Stain Biopsy Samples	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.