Moderate to severe nasolabial fold wrinkles Skin and Connective Tissue Diseases
Conditions
Interventions
This is a two-arm interventional study enrolling subjects with moderate to severe nasolabial fold wrinkles. Eligible participants are randomly allocated into either the experimental arm or the control
the product is administered into the middle to deep layer of facial dermis for the correction of moderate to severe nasolabial fold wrinkles, with injection dose determined per trial protocol.
Contro
the product is injected into the middle layer of facial dermal tissue to fill and correct moderate to severe nasolabial fold wrinkles, with the injection dose specified in the study protocol.
Sponsors
Shanghai Lumed Trading Co., Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male or female Chinese subjects aged 18 to 65 years old (inclusive) 2. Assessed by the investigator to have obviously visible and approximately symmetrical bilateral wrinkles, with consistent bilateral scores of 3 or 4 points on the 5-point Wrinkle Severity Rating Scale (WSRS), and having reasonable expectations for the wrinkle correction effect described in this study protocol 3. Voluntarily participate in this clinical trial and sign the informed consent form
Exclusion criteria
Exclusion criteria: 1. Abnormal laboratory test results judged clinically significant by the investigator and unsuitable for participation in the clinical study 2. Females of childbearing age who are pregnant, breastfeeding, planning to become pregnant, or not using reliable contraceptive measures, and are unwilling to adopt medically recognized contraceptive methods such as oral contraceptives, condoms and intrauterine devices during the trial period 3. The 5-point Wrinkle Severity Rating Scale score of unilateral or bilateral wrinkles is 1, 2 or 5 4. Obvious acne scars, active inflammation, infection, malignant lesions or precancerous lesions, or unhealed wounds in the injection site 5. Received facial plastic surgery, tissue transplantation, injection of silicone, fat grafting, or injection of other permanent or semi-permanent dermal fillers in the midface within 12 months prior to treatment 6. Received cosmetic botulinum toxin injection, laser resurfacing, photorejuvenation, intense pulsed light, radiofrequency therapy, dermabrasion, chemical peeling or other ablative and non-ablative procedures in the midface within 6 months prior to treatment 7. Used any oral or topical anti-wrinkle products at the treatment area within 90 days prior to treatment 8. Undergoing anticoagulant therapy such as warfarin, or having taken non-steroidal anti-inflammatory drugs including aspirin and ibuprofen, or other substances known to prolong coagulation time such as garlic and ginkgo-containing herbal supplements within 10 days before treatment. Note: Injection may be postponed if necessary to meet the 10-day washout period requirement 9. Participated in any other clinical trial within 3 months prior to treatment 10. Plan to receive any facial plastic surgery or cosmetic treatments such as thread lifting, thermolifting and midface tightening during the study period 11. History of severe allergic reactions, multiple allergies, hereditary allergy, allergy to hyaluronic acid products, or planned desensitization therapy during the study 12. Any other conditions deemed inappropriate for participation in this clinical study by the investigator
Countries
China
Contacts
Public ContactSufan Wu
Outcome results
None listed