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

University of California Irvine (UCI)

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Port Wine Stain

Treatments: Drug: Topical Antiangiogenic; Device: Pulsed Dye Laser

Study type: Interventional

Funder types: Other

Identifiers

NCT00969397

20097069

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Topical Antiangiogenic

Experimental group

Description:

Topical Antiangiogenic Agents

Treatment:

Drug: Topical Antiangiogenic

Pulsed Dye Laser

Experimental group

Description:

Pulsed Dye Laser

Treatment:

Device: Pulsed Dye Laser