A Study Comparing Lafullen15 and Lafullen for Temporary Nasolabial Fold Improvement
Status: Not yet recruiting

The objective of this clinical trial is to verify the safety and efficacy of Lafullen15 in the temporary improvement of nasolabial Folds

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Men and women between the ages of 19 and 70 Individuals who desire an improvement in the appearance of the nasolabial fold on both sides of the face and who have a score of 3 or 4 on the Wrinkle Severity Rating Scale (WSRS) Individuals who have consented to abstain from any other dermatological procedures or treatments, including treatments for wrinkle reduction in the facial area, during the duration of this study A person who voluntarily decided to participate in this clinical trial and gave written consent to the subject consent form  Exclusion Criteria:  Administered an anticoagulant (with the exception of low dosage aspirin (100mg, up to 300mg/day)) within 2 weeks of the date of the screening Administered Vitamin E or non-steroidal anti-inflammatory drugs or Collagen within 1 week of the date of the screening, or who require these during the period of the study History of bleeding disorder in past or present Received deep-peeling, skin regeneration, plastic surgery (including botulinum toxin injection), wrinkle improvement or acne scar treatment in the facial area within 24 weeks of the date of the screening Administered an hyaluronic acid filler within 24 weeks of the date of the screening Those who have received CaHA (Calcium Hydroxypatite), PLLA (Poly L-Lactide), or PMMA (Para-Methoxymethamphetamine), Polycaprolactone filler, etc. on the site where the clinical trial medical device is applied within 2 years from the screening date Those who have used topical application agents (steroids, retinoids: applicable to pharmaceuticals and cosmetics), functional cosmetics for wrinkle improvement on the face within 4 weeks from the screening date, or are planning to use them during the clinical trial period (However, for therapeutic purposes, steroid ointment should be used for 14 consecutive days) available for a short period of time) Those who have used immunosuppressants, chemotherapeutic agents, or systemic corticosteroids within 12 weeks of screening Those who insert permanent skin extension implants such as hardening gel (Softform) in the face Those who have facial skin disease or wound infection that may affect this clinical trial Those who have autoimmune disease or a history of autoimmune disease that may affect this clinical trial, or have reduced immunity Those with a history of hypertrophic scars or keloids on the face Those with a history of anaphylaxis or severe combined allergy symptoms Those who currently have streptococcal disease Those currently receiving cortisol treatment A person who has undergone skin augmentation at the treatment site or its adjacent area Those who have skin hypersensitivity to this clinical trial medical device in the results of the intradermal reaction test Those who have had side effects with amide-based local anesthetics, EMLA Cream, or equivalent lidocaine preparations Those with confirmed sarcoid granulomatous pathology or Oslers endodontitis Those who have clinically serious disorders in the cardiovascular system, digestive system, respiratory system, endocrine system, and central nervous system, or have had or currently have a psychiatric disorder that significantly affects this clinical trial Pregnant and lactating women  Among female subjects of childbearing potential, those who do not agree to contraception* by a medically accepted method up to 12 weeks after application of the investigational medical device in this clinical trial  * Medically accepted methods of contraception: condoms, oral contraceptives lasting for at least 6 months, use of injectable or implantable contraceptives, and intrauterine contraceptives installed, etc.  Those who have participated in other clinical trials within 4 weeks from the screening date and have been administered/applied clinical investigational drugs/clinical investigational devices Others who are deemed difficult to conduct this clinical trial when judged by the person in charge of the clinical trial - HealthyVolunteers: No - Gender: All - MinimumAge: 19 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult