LASSYS_Cadidates for Clinical Trials (Seoul, Korea)

compensation: You will receive a Honorarium of KRW 50,000 per visit. Honorariums for full participation in this study will be paid to a total of KRW300,000.

Our company is CLASSYS Inc. and we develop and distribute medical aesthetic devices. You can visit our website here to learn more about CLASSYS: www.classys.com

Currently, we are looking for candidates for our clinical trials to review the efficacy of our device the ULTRAFORMER III. The ULTRAFORMER III uses HIFU (High Intensity Focused Ultrasound) to lift and tighten the skin. Procedures are completely non-invasive and require zero downtime.

Please refer to the video here to learn more:

Study Title: An Assessment on the Safety and Efficacy of High Intensity Focused
Ultrasound (HIFU): Assessment of Safety and Efficacy for improvement of
wrinkles on periorbital, perioral, and neck regions

1. Clinical Study Purpose
To corroboratively assess the safety and efficacy of High Intensity Focused Ultrasound (HIFU) technology for improvement of wrinkles around the eyes, mouth, and neck regions.

2. Clinical Study Method
A. Duration of Clinical Study : approximately 17 weeks (119 days)
B. No. of Hospital Visits : 6 ~ 7 / No. of Treatments : 3
(※ 6 Hospital Visits : If screening and first procedure are conducted on the same day.)
C. This study will be conducted in a single location and subject will be randomly assigned to
one of 3 treatment groups [periorbital (eyes), perioral (mouth), and neck].
D. The subject will undergo evaluation of vital signs, physical exams, and other assessments
on visit.
(※ Subjects should expect that each visit that includes treatment will take approximately
2 hours and 30 minutes and 2 hours per visit that exclude treatments.)

3. Criteria for Participation
A. Healthy subjects between the ages of 30 – 65
B. Subjects who are interested in improving wrinkles around the eyes, mouth and neck
C. Subjects with visible wrinkles around the eyes, mouth, and neck based on clinical imaging assessment.
D. Subjects who understand and follow the instructions may participate in the entire duration of this clinical trial

4. Inclusion Criteria
For subjects who formally consent to participate in this clinical trial (which includes undergoing evaluation and treatments) a series of surveys and tests will be conducted to determine your eligibility as a study subject.

5. Expected Adverse Events
A. Hypersensitivity due to topical application of a local anesthetic (only when the subject uses
Emla Cream)
B. During & Post Treatment : heat sensation, pain, stinging, erythema(redness), edema
(swelling), itching, ecchymosis(bruising), blisters, hyperpigmentation, hypopigmentation,
dysesthesia(for example , burning sensation), numbness
C. Please be aware that participating in the clinical trial could result in the possibility of unexpected adverse events.

6. Principal Investigator
Beom-Joon Kim, M.D. / Department of Dermatology, Chung-Ang University Hospital
(102, Heukseok-ro, Dongjak-gu, Seoul, Rep. of Korea), (☎: 02-6299-1527)

7. Sponsor
CLASSYS (Inc.) / 240, Teheran-ro, Gangnam-gu, Seoul, Rep. of Korea, ( ☎ : 070-5165-0024 )

8. Contact
Please refer to the following contact information for further inquiry.
_ ALLiVEC homepage : https://www.alllivec.co.kr / ☎ : 1644-3685 [Call center]
_ ALLiVEC Google Play App : https://play.google.com/store/apps/details?id=com.kwave.alllivec
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*The period of registration for candidates will be from 1/7 – 31/7, 2020. You will be contacted by a member of our team in regards to when the study will begin.

*This Advertisement will be closed When we get 2 candidates for clinical trials.

The location of the study is Chung-Ang University Hospital in Seoul (closest subway stop is line #6 Heukseok Station.

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* For this particular study we are looking for candidates that wish to improve wrinkles around their eyes area.
*** Please refer to the photos attached for more information.

Please use the link below to apply for a position as a candidate:
https://docs.google.com/forms/d/1SCzms3pSety7PrfGM3n2RVbkqi3vdg-rYJWvzXMgJ64/edit

Thank you!