NCT04103164

Pilot Study to Evaluate the Effect of Multiple Passes on Port Wine Stain Treatments With the Cutera Excel V™ Laser.

Open Label, Prospective, Single-Center Pilot Study to Evaluate the Effect of Multiple Passes on Port Wine Stain Treatments With the Cutera Excel V™ Laser.

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Two limitations of single pulse, laser treatment of port-wine stains (PWS) are: (i) hemorrhage and purpura which may lead to post-treatment pigmentation and (ii) the necessity for repeated treatment sessions. In contrast, multiple pulses induce summation of irreversible, thermal injury from a series of lower-peak temperature heating cycles and may therefore reduce mechanical injury while preserving the selectivity of photothermal injury. Ideally, hemorrhage could be prevented and the efficiency of vessel closure could be greater. A clinical and histological pilot study of 10 adults with either facial or non-facial PWS is therefore proposed here.

Conditions

• Port-Wine Stain

Interventions

Type	Name	Description
DEVICE	Cutera excel V™ Laser	The Cutera® excel V laser is manufactured by Cutera, Inc. This laser with 532 nm KTP and 1064 nm Nd:YAG wavelengths has received 510(k) clearance by the U.S. Food and Drug Administration (FDA) to market the device for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue 510(k) number 022226. The 532 nm wavelength is indicated for the coagulation and hemostasis of benign vascular and cutaneous lesions in dermatology including, but not limited to, benign vascular lesions like angiomas, hemangiomas, port wine stains, venous anomalies and telangiectasia; benign pigmented lesions like nevi, lentigines, chloasma, café-au-lait; verrucae; skin tags; keratoses; plaques. The Cutera® excel V laser has also obtained the European CE Mark. The system was tested to ensure compliance with federal laser performance standards as applicable.

Timeline

• Start date: 2020-01-15
• Primary completion: 2020-07-15
• Completion: 2020-07-15
• First posted: 2019-09-25
• Last updated: 2019-10-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study