Combined Use of Pulsed Dye Laser and Topical Antiangiogenic Agents for Treatment of Port Wine Stain Birthmarks

Port Wine Stain Clinical Trial

Official title:

Combined Use of Pulsed Dye Laser and Topical Antiangiogenic Agents for Treatment of Port Wine Stain Birthmarks

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00969397
• Other study ID #: 20097069
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: November 2009
• Est. completion date: September 2011

Study information

• Verified date: October 2022
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The researcher want to improve port wine stain (PWS) therapeutic outcome in response to laser therapy. The researcher want to determine whether the combined use of pulsed dye laser (PDL) therapy and topical tacrolimus or pimecrolimus will improve PWS therapeutic outcome.

Description:

Both topical agents inhibit nuclear factor of activated T-cells (NFAT) which blocks the calcineurin/NFAT pathway inhibiting endothelial cell proliferation and angiogenesis, which could be very useful in preventing PWS recanalization.

The combined use of PDL to induce PWS blood vessel injury, and topical antiangiogenic agents to prevent PWS blood vessel angiogenesis and recanalization after laser therapy, will improve PWS lesion blanching.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• 16 years of age and older

• Have PWS suitable for comparison testing as determined by the study doctor

Exclusion Criteria:

• Less than 16 years old

• Are pregnant

• Have skin cancer

• Currently taking immunosuppressive or steroids or photosensitizing drugs

• Current participation in any other investigational drug evaluation

• Concurrent use of known photosensitizing drugs

Related Conditions & MeSH terms

• Hemangioma, Capillary
• Port Wine Stain
• Port-Wine Stain

Intervention

Drug:
• Topical Antiangiogenic
Topical Antiangiogenic

Device:
• Pulsed Dye Laser
Pulsed Dye Laser

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Beckman Laser Institute University of California Irvine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improve PWS lesion blanching.		8 weeks
Secondary	To determine whether the combined use of pulsed dye laser (PDL) therapy and topical agent will improve PWS outcome.		8 weeks