Clinical Trial to Study the Efficacy and Safety of Rejeunesse Shape With Lidocaine (HA Filler) in Treating Healthy Subjects

Randomized, Double-Blind, Single-Center Clinical Trial to Study the Efficacy and Safety of Rejeunesse Shape With Lidocaine (HA Filler) in Treating Healthy Subjects

Intend to prove the non-inferiority of Rejeunesse against the comparing medical device of Restylane Perlane in terms of improvement, efficacy, and safety of nasolabial fold on the face

Inclusion Criteria:

1. Men and women aged more than 30 but less than 60;
2. Those with score 3 or 4 in the wrinkle severity rating scale (WSRS) among those who want the improvement of nasolabial folds;
3. Those with visually symmetrical with nasolabial folds;
4. Those who agree with the suspension of all the dermatological treatment including the improvement of wrinkle on the face during the clinical study;
5. Those who are able to read and follow instructions and participate during the entire period of clinical study;
6. Those who decide to participate in the clinical study on their wills and agree with the subject-agreement written form.

Exclusion Criteria:

1. Those with skin sensitiveness on the clinical medical devices according to the result of intradermal test in the screening period;
2. Those who were administered with the antithrombotic (I00mg, up to 300mg/day) or anti-steroid anti-inflammatory within 2 days from the screening;
3. Those taking the antithrombotic (low-capacity aspirin (100mg, up to 300mg/day) excluded) during the clinical study or abnormal blood coagulation or liver function;
4. Those who have used or are scheduled to use the part ointment on the facial surface within 4 weeks from the screening date (steroid, retinoid: only for the medicines and not the cosmetics);
5. Those treated for the improvement of wrinkle or pimp within 6 months from the screening date;
6. Those treated for improvement of wrinkle by using collagen or hyaluronic acid filler within 6 months from the screening date or decortication, skin regeneration treatment, or plastic surgery on the facial surface (including botox wrinkle treatment);
7. Those treated with application of clinical medical devices for CaHA (Calcium Hydroxy Apatite) within a year from the screening date;
8. Those inserted with permanent skin extending implant such as soft form or silicon on the facial surface
9. Those in need of treatment on facial surface but with scar not treated for more than a year or with scar on the areas applied with clinical medical devices;
10. Those with the history of anaphylaxis or sever complex allergy symptoms;
11. Those with history of hypertropic scar or keloid medical history;
12. Those with side effect on the EMLA cream in the past (NIA for the criteria of exclusion for subjects who are not to use the EMLA cream);
13. Those with skin problem or infection from cut influencing on this clinical study;
14. Those with degraded immune function;
15. Those with clinically serious problem on cardiovascular system, digestive system, respiratory system, endocrine system, and central nervous system or mental disease that significantly influences on this clinical study;
16. Those participating in other clinical studies within 30 days from the screening date;
17. Those who did not agree to participate in the contraception in the medically allowed methods among female subjects who are able to be pregnant during the clinical study; * Medically allowed contraception method: Condom, oral contraception for more than 6 months, cases of using shot or inserting anti-conceptive or installing conceptive device in the womb;
18. Pregnant women or lactating women;
19. Other than aforementioned subjects, those with clinical opinion regarding them as inappropriate subjects in this study from the medical judgment from charging person or manager of this study.