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

• Sponsor: University of California, Irvine (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00969397
• Collaborator: Beckman Laser Institute University of California Irvine (Other)
• Enrollment: 0
• Arms: 2
• Duration (Months): 22

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Port Wine Stain	Drug: Topical Antiangiogenic; Device: Pulsed Dye Laser	Phase 1/Phase 2

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Combined Use of Pulsed Dye Laser and Topical Antiangiogenic Agents for Treatment of Port Wine Stain Birthmarks
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Topical Antiangiogenic Topical Antiangiogenic Agents	Drug: Topical Antiangiogenic; Topical Antiangiogenic
Experimental: Pulsed Dye Laser Pulsed Dye Laser	Device: Pulsed Dye Laser; Pulsed Dye Laser

Outcome Measures

Primary Outcome Measures

1. Improve PWS lesion blanching. [8 weeks]

Secondary Outcome Measures

1. To determine whether the combined use of pulsed dye laser (PDL) therapy and topical agent will improve PWS outcome. [8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of California, Irvine
• Beckman Laser Institute University of California Irvine

Investigators

• Principal Investigator: John S Nelson, M.D,PhD, Beckman Laser Institute University of California Irvine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Beckman Laser Institute and Medical Center, J S Nelson, M.D., Ph.D.,Professor of Surgery and Biomedical Engineering, University of California, Irvine
• ClinicalTrials.gov Identifier: NCT00969397
• Other Study ID Numbers: NIH-LAMMP-2009-7069
• First Posted: Sep 1, 2009
• Last Update Posted: Feb 10, 2017
• Last Verified: Feb 1, 2017

• Keywords provided by Beckman Laser Institute and Medical Center, J S Nelson, M.D., Ph.D.,Professor of Surgery and Biomedical Engineering, University of California, Irvine: Birthmark; PWS
• Additional relevant MeSH terms: Hemangioma, Capillary; Port-Wine Stain; Angiogenesis Inhibitors

Study Results

No Results Posted as of Feb 10, 2017