Nasolabial groove wrinkle
Conditions
Interventions
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Male and female subjects aged 18-65 years, including 18-65 years. 2) Nasolabial crease WSRS grade 3-4 and wish to correct the subject. 3) Subjects with nasolabial crease of the same WSRS grade on both sides. 4) Participants who agreed not to use other cosmetic treatments related to the study. 5) Understand and comply with the requirements of the trial, can complete the whole follow-up process of the subjects. 6) Volunteer to participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) A pregnant or lactating women. 2) Women of child-bearing age did not agree to use medically approved contraceptive methods (e.g. oral contraceptives, condom, intrauterine device) during the trial. 3) The abnormal laboratory results were judged by the researcher as having clinical significance. 4) Subjects with scarring or skin diseases in the trial treatment area that may affect the judgment of treatment efficacy, or with active inflammation and/or unhealed wounds. 5) Subjects with active inflammation and skin infection in the experimental treatment area. 6) Subjects who had received silicone or other permanent dermal fillers in the treatment area. 7) Subjects who had undergone facial lifting surgery or catgut-embedding surgery within 1 year of the screening period. 8) The subjects were treated with sodium hyaluronate or other semi-permanent dermal fillers within 1 year before the screening period. 9) Within 6 months before the screening period, the subjects underwent other treatments such as botulinum toxin injection, radiofrequency ablation, focused ultrasound, laser peels, grinding, chemical peeling, etc. 10) Participants who had used anticoagulant, antiplatelet, or thrombolytic therapy (e.g. , Warfarin, aspirin) within 14 days before study treatment or planned to use it within 3 days after study treatment. 11) Had a history of multiple severe allergies, a history of inherited allergies, a history of allergy to hyaluronic acid products or streptococcal protein, and planned desensitization treatment during the study period. 12) The subjects had a history of serious diseases of their vital organs or autoimmune diseases. 13) The subjects had a history of hypertrophic scar or scar formation. 14) Subjects who had participated in other clinical trials within 30 days before the screening period. 15) The study participants were considered unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects with a WSRS rating improvement of = 1 compared to baseline evaluated by the evaluator on the 24th ± 7th day after the last treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| At 4 weeks ± 5 days, 12 weeks ± 7 days, and 52 weeks ± 14 days after the last treatment, the percentage of subjects with a WSRS rating improvement of = 1 level compared to baseline was evaluated by the evaluator;At 4 weeks ± 5 days, 12 weeks ± 7 days, 24 weeks ± 7 days, and 52 weeks ± 14 days after the last treatment, the investigator evaluated the improvement of GAIS;At 4 weeks ± 5 days, 12 weeks ± 7 days, 24 weeks ± 7 days, and 52 weeks ± 14 days after the last treatment, the improvement in WSRS rating compared to baseline was evaluated by the treatment researcher;At 4 weeks ± 5 days, 12 weeks ± 7 days, 24 weeks ± 7 days, and 52 weeks ± 14 days after the last treatment, the improvement of GAIS was evaluated by the subjects;Satisfaction assessment will be conducted by the subjects at 4 weeks ± 5 days, 12 weeks ± 7 days, 24 weeks ± 7 days, and 52 weeks ± 14 days after the last treatment; | — |
Countries
China
Contacts
Public ContactZhao Hongyi
Beijing Hospital
Outcome results
None listed