-Research Objective: To evaluate safety and effectiveness of Dual Wavelength Long-pulsed 755nm Alexandrite/1,064nm Nd:YAG laser device for treatment of cutaneous vascular lesions (rosacea, nevus flammeus) through follow-up observation for a total of 6 months. 

-Research design summary: Rosacea is a common skin disease that occurs on the face. The central part of the face such as the nose and cheeks becomes red, and vasodilation occurs. In severe cases, papules or pustules may occur. The cause of rosacea has not been identified yet, but facial flushing and vasodilation are expected to be associated with abnormal vascular control function caused by various stimulations. Rosacea is a chronic recurrent skin disease that is difficult to treat, and treatment methods vary depending on the severity of the disease. Initially, topical treatment and oral drug treatment are performed, but those treatments require long-term administration. Facial flushing or telangiectasia in rosacea often requires vascular laser treatment, and devices such as intense pulsed light (IPL), pulsed dye laser (PDL) or long-pulsed Nd:YAG are mainly used. 
Nevus flammeus usually appears as a widespread red spot, but as it grows, the lesion grows larger to form a raised, thickened lesion. In the past, surgical resection, cryotherapy, and vascular embolization had been performed, but the side effects caused by these procedures such as scars are often debilitating and recurrences are common. Particularly, when there is thick facial lesion, it is classified as an intractable cutaneous vascular disease that must be treated as it can be accompanied by social restrictions beyond cosmetic problems. Vascular target laser devices such as pulsed dye laser (PDL) or long-pulsed Nd:YAG are developed and showed excellent treatment progress, but long-term treatment is required for more than 10 times for several years, and adult lesions are still difficult to treat. Therefore, in this study, we would like to compare long-pulsed 755nm Alexandrite wavelength plus long-pulsed 1,064nm Nd:YAG wavelength for rosacea patients, and long-pulsed 1,064nm Nd:YAG wavelength for nevus flammeus patients with widely used pulsed dye laser (PDL).

-Research Method: This clinical study is conducted in a total of 50 subjects with vascular lesions of the skin (rosacea; 25, nevus flammeus; 25) on each side of the face randomly assigned CLARITY II laser treatment or 585nm Pulsed Dye Laser treatment. Laser treatment is performed 4 times on 0 weeks (visit 1), 4 weeks (visit 2), 8 weeks (visit 3), 12 weeks (visit 4). Then we will compare the effect of each laser treatment on the improvement of cutaneous vascular lesions at 16 weeks (visit 5) and 24 weeks (visit 6).
At all visits, a clinical picture of the lesion at the treatment site is taken. Two dermatologists will compare the clinical pictures before the procedure (V0/V1), 4 weeks after the first procedure (V2), 12 weeks (V4), and 4 weeks after the last procedure (week 16, V5). The degree of improvement of cutaneous vascular lesions is measured using a 5-step scale. 
At all visits, the treatment site lesion is evaluated using the Mark-VuTM skin measuring device and the degree of redness of the skin lesion using a Mexameter. Objective degree of improvement of vascular lesions is evaluated by the values measured before the procedure (V0/V1), 4 weeks after the first procedure (V2), 12 weeks (V4), and 4 weeks after the last procedure (week 16, V5).
A questionnaire survey to evaluate the subject's treatment satisfaction for the treatment of skin vascular lesions is conducted at 4 weeks (16 weeks; visit 5) and 3 months (24 weeks; visit 6) after the last treatment using a 5-step scale.

Treatment

In the random selection method of the test group and the control group, in the case of rosacea patients, each side on the face of the subject is assigned, and in the case of nevus flammeus patients, the inner and outer sides of the lesion are assigned to the test group and the control group as follows. 

I. Rosacea (Severance Hospital)
1) Treatment group
 Dual Wavelength Long-pulsed 755nm Alexandrite/1,064nm Nd:YAG 1,927nm (Lutronic Clarity II)
: Alexandrite - Fluence (10 J/cm2), spot size (10 mm), pulse width (20 ms), 2 pass
+ Nd:YAG – Fluence (4J/ cm2), spot size (10 mm), pulse width (0.3 ms), 1 pass

2) Control group
 585 nm Pulsed Dye Laser (Candela Vbeam)
: Fluence (8 J/cm2), spot size (10 mm), pulse width (10 ms), 2 pass

II. Nevus flammeus (Yongin Severance Hospital)
1) Treatment group
Dual Wavelength Long-pulsed 755nm Alexandrite/1,064nm Nd:YAG 1,927nm (Lutronic Clarity II)
: Alexandrite - Fluence (60 J/cm2), spot size (5 mm), pulse width (20 ms), 2 pass

2) Control group
595 nm Pulsed Dye Laser (Regenlite DDR) 
: Fluence (10 J/cm2), spot size (3 mm), pulse width (1.5 ms), 2 pass

* The above treatment can be changed according to the appropriate endpoint and skin condition of the subject for each indication.

Arm Label

Target Number of Participant

Arm Type

Arm Description

In the case of rosacea patients (25), the unilateral face corresponding to the test group is irradiated with the following parameters using a Clarity II laser device.
: Alexandrite - Fluence (10 J/cm2), spot size (10 mm), pulse width (20 ms), 2 pass
+ Nd:YAG – Fluence (4J/ cm2), spot size (10 mm), pulse width (0.3 ms), 1 pass

In the case of nevus flammeus patients (25 patients), the laser is irradiated with the following parameters to the side corresponding to the test group among the inner/outer lesions.
: Alexandrite - Fluence (60 J/cm2), spot size (5 mm), pulse width (20 ms), 2 pass

Arm Label

Target Number of Participant

Arm Type

Arm Description

In the case of rosacea patients (25 patients), the unilateral face corresponding to the control group is irradiated with the following parameters using a Vbeam laser device.
: Fluence (8 J/cm2), spot size (10 mm), pulse width (10 ms), 2 pass

In the case of nevus flammeus patients (25 patients), the laser is irradiated with the following parameters to the side corresponding to the control group among the inner/outer lesions.
: Fluence (10 J/cm2), spot size (3 mm), pulse width (1.5 ms), 2 pass

Gender

Age

Description

1) Adults aged 19-65
2) Individuals with cutaneous vascular lesions (rosacea, nevus flammeus)
3) Individuals who understands the purpose and methods of this trial
4) Individuals who can regularly visit our hospital
5) Individuals who agrees to avoid any other dermatologic therapies other than our treatment material

1) Whom denies to participate
2) Pregnant women, breast feeding women
3) Subjects judged to be unsuitable by the person in charge of the clinical trial for the following conditions
①	In case of infectious or inflammatory skin disease at the treatment site
②	In case of pigmented skin diseases such as spots at the treatment site
③	In case of keloid or collagen or elastic fiber disease
④	In case of chronic wasting disease (asthma, diabetes, etc.)
⑤	When there is a risk of bleeding by taking an anticoagulant
⑥	In case of an autoimmune disease
⑦	Person with psychiatric problems
⑧	Person with acute illness
4) Other cases when it is difficult to conduct the clinical (ex. illiteracy, foreigners)

5-point scale Global Aesthetic Improvement Scale (GAIS) evaluated based on clinical photos

0,4 week,8 week,12 week,16 week

Mark-vu, Mexameter, subjective improvement graded by participants

0,4 week,8 week,12 week,16 week

Sujin Park MD, Joo Hee Lee MD, Eunji Kang BA, Hyun Kim BA, Ji Young Kim MA, Eun Jung Lee PhD, Yu Jeong Bae MA, Jihee Kim MD, PhD, Sang Ho Oh MD, PhD. A randomized split-face comparative study of long-pulsed alexandrite plus low-fluence Nd:YAG laser versus pulsed-dye laser in the treatment of rosacea. Lasers in Surgery and Medicine. SCI. 2022-10-02 ,
														 VOL : 54 page : 1217 ~ 1225
														https://doi.org/10.1002/lsm.23605
														

The erythema index (EI) significantly decreased on both treated sides (LPAL 366.5 ± 101.0 vs. 295.8 ± 90.2, p < 0.001, PDL 369.0 ± 124.3 vs. 302.7 ± 92.1, p < 0.001) 1 month after fourth treatment (visit 5). Also 3 months after the fourth treatment (visit 6), the reduction in the EI was well maintained on both sides (LPAL 360.3 ± 96.8 vs. 282.0 ± 89.2, p < 0.001, PDL 364.3 ± 121.6 vs. 281.6 ± 97.8, p < 0.001). When comparing the improvement in the EI between the two groups, the percentage reduction in the EI on the LPAL-treated side was not inferior to the PDL-treated side (visit 5: LPAL 18.7 ± 15.7% vs. PDL 16.4 ± 12.9%, p = 0.501 and visit 6: LPAL 21.7 ± 13.9% vs. PDL 21.9 ± 15.2%, p = 0.943).