Moderate to severe neck wrinkles
Conditions
Interventions
experimental group:injection treatment for horizontal neck lines
control group:injection treatment for horizontal neck lines
Sponsors
The Second Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-75 years old (including both age limits), no gender restrictions; 2. Individuals with a desire to improve neck wrinkles and who, as assessed by a blinded investigator, have a moderate or severe rating on the Transverse Neck Lines Severity Scale (TNLS) (corresponding to a score of 2 or 3); 3. Able and willing to follow the researcher's instructions and complete all visits required for this trial; 4. Voluntarily participate in this clinical trial and sign the informed consent form for participants.
Exclusion criteria
Exclusion criteria: 1. Individuals who have undergone neck trauma surgery in the transverse neck wrinkle area within the past six months and have scars; individuals with skin diseases, obvious acne scars, bacterial or viral infections, cancerous or precancerous lesions, or unhealed wounds in the neck area; 2. Those who have undergone permanent or semi-permanent dermal filler treatment on the neck or plan to undergo filler treatment during the study period; 3. Those who have undergone other wrinkle treatment on the neck within 24 weeks prior to screening, such as botulinum toxin, laser treatment, dermabrasion, chemical peeling, etc.; 4. Those who have undergone injection therapy with temporary fillers such as cross-linked hyaluronic acid in the neck within 48 weeks prior to screening, or those who have undergone injection therapy with non-cross-linked hyaluronic acid in the neck within 24 weeks prior to screening; 5. Individuals with a known allergy to any of the following product components: sodium hyaluronate, glycine, proline, alanine, valine, leucine, lysine hydrochloride, arginine hydrochloride, niacinamide, or individuals with an allergy to lidocaine-type local anesthetics, or those currently experiencing an allergic reaction. 6. Individuals with keloid scarring; 7. Those with a tendency to bleed or who have used anticoagulants (heparin, warfarin, and sodium citrate) within 2 weeks prior to injection; 8. Patients with a platelet count below 50 × 10?/L or coagulation abnormalities (APTT > 1.5 times the upper limit of normal) during the screening period; 9. Those with abnormal liver and kidney function during the screening period (AST, ALT > 1.5 times the upper limit of normal values or Cr > upper limit of normal values), or those with a history of autoimmune diseases such as rheumatism, lupus erythematosus, and other connective tissue diseases; 10. Those with epilepsy or cognitive impairment; 11. Pregnant or breastfeeding women, or those planning to become pregnant during the study period; 12. Participants who have participated in other interventional device clinical trials within one month prior to the start of this trial, or who have participated in drug clinical trials within five half-lives of the last dose; 13. Researchers who deem other individuals unsuitable for participation in clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy rate of neck wrinkle correction improvement 12 weeks after the last injection; | — |
Secondary
| Measure | Time frame |
|---|---|
| injection of the Investigator's Neck Wrinkle Severity Rating Scale (TNLS) score;blinded investigator's neck transverse wrinkle severity grading scale (TNLS) score;subject satisfaction evaluation;Subjects' ratings of global aesthetic improvement score (GAIS);Researchers' scores for global aesthetic improvement (GAIS); | — |
Countries
China
Contacts
Public ContactWei Cai
The Second Affiliated Hospital of Nanjing Medical University
Outcome results
None listed