Nasolabial folds
Conditions
Interventions
Treatment Group:use modified sodium hyaluronate gel for injection with lidocaine
Control Group:use modified sodium hyaluronate gel for injection
Sponsors
Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1) Age =18 years old, male or female; 2) The researchers judged that bilateral nasolabial wrinkles were moderate to severe (3 to 4 points according to the wrinkle Severity rating scale) and the bilateral scores were consistent, hoping to improve; 3) agree not to perform other cosmetic treatments on the face below the infraorbital margin during the trial period; 4) Voluntarily participate in the study, sign informed consent, fully understand the test content, process and possible adverse reactions, and agree to participate in all visits, examinations and treatments as required by the test plan.
Exclusion criteria
Exclusion criteria: 1) Pregnant, nursing and puerperal women and those with pregnancy plans during the trial; 2) There are serious mental disorders, psychological disorders, personality disorders or are taking antipsychotic drugs; 3) have a history of serious diseases of important organs (cardiovascular system, lung, liver, kidney and nervous system, etc.); 4) diabetes, autoimmune disease or abnormal coagulation function; Patients who have received immunosuppressants or treatment that affects immune function within 3 months before injection; Patients who have received thrombolysis, anticoagulation, antiplatelet aggregation therapy within 2 weeks prior to injection, or need to receive the above therapy within 2 weeks after injection; 5) cicatricial constitution (easy to form hypertrophic scars or keloids); 6) Allergic to hyaluronic acid or any component of this product, allergic to local anesthetic drugs (such as lidocaine or other amide anesthetic drugs), or have a history of allergy to other materials covered by this test; Have a history of severe allergies or multiple allergies; 7) There is systemic and treatment site infection, or there is inflammation in the treatment site, active skin disease; 8) There are facial sensory abnormalities such as hypoaesthesia, numbness or neuralgia; 9) nasolabial groove or adjacent area has the following conditions: left and right nasolabial groove structure asymmetry; History of unhealed wounds, tissue defects, pathological soft tissue atrophy, malformations, scars, precancerous or cancerous changes, radiotherapy; 10) Those with the presence of the following previous treatments or who plan to receive the following treatments during the study period in the nasolabial groove or adjacent area: has had surgery, permanent implants (e.g., polymethyl methacrylate, silicone, teflon), or fat fillings; Semi-permanent fillers (such as hydroxyapatite and poly-L-lactic acid) were injected within 3 years prior to enrollment; Temporary fillers (such as hyaluronic acid, collagen) had been injected within 12 months before enrollment; In the 6 months prior to admission, patients had received botulinum toxin injection, energy or radiofrequency therapy (e.g., ultrasound cannon, hot marge), lipopolytic therapy (e.g., deoxycholic acid injection, cryopolytic therapy), or exfoliative therapy (e.g., exfoliative laser, chemical exfoliation); Received plastic therapy (such as water needle, microneedle) or non-stripping laser within 3 months before enrollment; 11) The facial area below the infraorbital margin had undergone plastic surgery, fillers, botox injections, or cosmetic procedures (such as laser, radiofrequency, lipopolysis, and plastic therapy) within 30 days prior to enrollment; 12) Participants in any other clinical trial within 30 days before signing the informed consent; 13) There are people who are judged by other researchers as not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Injection pain; | — |
Countries
China
Contacts
Public ContactJin Peisheng
Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed