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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
Massachusetts General Hospital
Boston, Massachusetts, United States
Optimal Fluence based on efficacy and safety measurements using photographs
Find the optimal fluence in a multiple split port wine stain treatment, with 2 J/cm2 (low fluence control) vs 4 J/cm2 vs 6 J/cm2 vs 8 J/cm2 in the multiple-pass approach, compare it to our standard single-pass approach at 8 J/cm2. -The efficacy of treatment assessed by improvement in PWS among the 5 treated areas using before and after digital photographic assessment. Each digital photographic image will include a color card, so that changes can be compared from day 0 to final visit. The hypothesis is that the effect of multiple passes on Port Wine Stain treatments with the Cutera excel V™ Laser would be more effective than the current single pass treatment.
Time frame: 6 months
Optimal Fluence based on efficacy and safety measurements using questionnaires/surveys.
\- Safety will be assessed by questionnaires/surveys about frequency and severity of post treatment side-effects among the 5 treated areas after one treatment throughout the study, such as using the Visual Analog Score for Pain. The hypothesis is that the effect of multiple passes on Port Wine Stain treatments with the Cutera excel V™ Laser would be more safe than the current single pass treatment.
Time frame: 6 months
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