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

Inclusion criteria

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

Exclusion criteria

• Those with skin sensitiveness on the clinical medical devices according to the result of intradermal test in the screening period;
• Those who were administered with the antithrombotic (I00mg, up to 300mg/day) or anti-steroid anti-inflammatory within 2 days from the screening;
• Those taking the antithrombotic (low-capacity aspirin (100mg, up to 300mg/day) excluded) during the clinical study or abnormal blood coagulation or liver function;
• 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);
• Those treated for the improvement of wrinkle or pimp within 6 months from the screening date;
• 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);
• Those treated with application of clinical medical devices for CaHA (Calcium Hydroxy Apatite) within a year from the screening date;
• Those inserted with permanent skin extending implant such as soft form or silicon on the facial surface
• 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;
• Those with the history of anaphylaxis or sever complex allergy symptoms;
• Those with history of hypertropic scar or keloid medical history;
• 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);
• Those with skin problem or infection from cut influencing on this clinical study;
• Those with degraded immune function;
• 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;
• Those participating in other clinical studies within 30 days from the screening date;
• 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;
• Pregnant women or lactating women;
• 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.