Efficacy and Safety of HMM1-022 in Temporary Correction of Crow's Feet

A single center, subject & evaluator-blind, randomized, matched pairs, active-controlled, confirmatory study to evaluate the efficacy and safety of HMM1-022 in temporary correction of Crow's feet

Inclusion criteria

• Adult aged 19 years or older
• Individuals who have voluntarily decided to participate in the clinical trial after receiving and understanding a detailed explanation, and who have provided written consent
• Individuals who have agreed to discontinue all dermatological treatments, including wrinkle treatments around the eyes, during the clinical trial period

Exclusion criteria

• Individuals with a history of anaphylaxis or severe allergic diseases that may affect the clinical trial
• Individuals diagnosed with autoimmune diseases, sarcoid granulomatous pathology, or Osler's endocarditis
• Individuals with hypersensitivity to the investigational medical device, its components (polynucleotide sodium, hyaluronic acid sodium, lidocaine), or other amide-type local anesthetics
• Individuals with a history of bleeding disorders
• Individuals with a history of facial nerve paralysis or ptosis
• Individuals with significant facial asymmetry that may affect the clinical trial
• Individuals with skin diseases, infections, or abnormalities such as scars in the eye area that could affect the clinical trial
• Individuals with a history of keloid formation, hyperpigmentation, or hypertrophic scar in the evaluation area
• Individuals with a history of malignant tumors within 5 years prior to Visit 1 (screening), except those with treated basal cell or squamous cell skin cancer not in the eye area, or treated cervical cancer
• Individuals with clinically significant disorders or psychiatric conditions affecting the cardiovascular, gastrointestinal, respiratory, endocrine, immune, or central nervous systems, or those with conditions that may significantly impact the clinical trial
• Individuals who have undergone or are scheduled to undergo treatments affecting the efficacy assessment of crow's feet wrinkles during the following periods:

• Within 24 months before Visit 1 (screening) using Poly(L-Lactide) or Poly(ε-Caprolactone) for wrinkle treatment
• Within 18 months before Visit 1 (screening) using Calcium hydroxylapatite (CaHA) for wrinkle treatment
• Within 12 months before Visit 1 (screening) using hyaluronic acid for wrinkle treatment
• Within 6 months before Visit 1 (screening) using collagen, botulinum toxin, or other wrinkle treatments
• Within 6 months before Visit 1 (screening) undergoing invasive laser, deep dermabrasion, or other procedures or surgeries related to wrinkle treatment in the eye area
• Insertion of permanent skin expansion implants like Softform or silicone in the eye area before screening
• Starting or receiving a new oral or topical anti-wrinkle medication with wrinkle prevention effects within 3 months before Visit 1 (screening)
• Individuals who have undergone the following drug therapies that could affect the evaluation of the investigational medical device:

• Use of NSAIDs, antiplatelet agents, anticoagulants, immunosuppressants within 2 weeks before Visit 1 (screening), or required during the clinical trial period (excluding low-dose aspirin (100 mg, up to 300 mg/day))
• Use of topical agents (steroids, retinoids: only medications, not cosmetics) in the eye area within 1 month before Visit 1 (screening) or planned use during the clinical trial
• Individuals who have received a COVID-19 vaccine within 3 weeks before the application of the investigational medical device or are planned to receive it within 4 weeks after application
• Individuals with ongoing infectious diseases, including COVID-19, or suspected COVID-19 infection within 2 weeks before screening
• Individuals who have been administered or undergone other investigational drugs or devices within 1 month before Visit 1 (screening), or within 6 months for studies related to crow's feet wrinkles
• Individuals with positive results for viral tests (HBs Ag, HCV Ab, HIV Ab) performed at Visit 1 (screening) or within 1 month before screening
• Individuals with a history of alcohol or drug addiction
• Pregnant or breastfeeding women
• Individuals planning to become pregnant during the clinical trial or those who, along with their partners (or spouses), do not agree to use medically acceptable contraception methods (examples include: hormonal contraceptives, proven failure rates intrauterine devices (IUDs), double barrier methods, sterilization)
• Individuals deemed unsuitable for participation in the clinical trial based on the investigator's judgment