Shape the back and/or root of the nose
Conditions
Interventions
Control group:Use a modified sodium hyaluronate gel for injection
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) No gender limitation, age =18 years old; 2) Beauty seekers who have the desire to shape the back and/or root of the nose; 3) The investigator believes that a product =1 mL can be used to obtain a clinically meaningful cosmetic correction of the subject's nose; 4) Able and willing to follow the guidance of the researchers and complete all visits in this study as required; 5) Participants who voluntarily participate in the clinical trial and sign the subject informed consent.
Exclusion criteria
Exclusion criteria: Subjects will not be enrolled in this study if they meet any of the following criteria: 1. Known allergy to sodium hyaluronate or lidocaine local anesthetics; 2. Patients with abnormal coagulation mechanism during the screening period, or who had received any thrombolytic agent, anticoagulant or antiplatelet drug within 1 week before enrollment; 3. Patients who have received any permanent or semi-permanent fillers or autologous fat fillers between the eyebrow and nasal region; 4. Patients who had received other temporary fillers such as crosslinked hyaluronic acid or collagen injection in the glabellar and nasal regions during the 12 months prior to enrollment; 5. Patients who had received non-crosslinked hyaluronic acid treatment or had received any wrinkle removal treatment in the interglabella and nasal area in the 3 months prior to enrollment; 6. There are scars, deformities, unhealed wounds, active skin diseases or skin inflammation, active or persistent infections, cancerous or precancerous lesions in the nasal region that may affect the evaluation of efficacy or increase the risk of treatment; 7. Patients with active autoimmune disease or history; 8. Patients who had received chemotherapy, immunosuppressants, immunomodulatory therapy (such as monoclonal antibodies) or systemic corticosteroids (except inhaled corticosteroids) within 3 months before enrollment; 9. According to the judgment of researchers, those with severe dysfunction of important organs (such as the brain, heart, lungs, liver, kidneys, etc.) and those with serious mental system diseases; 10. Those who plan to undergo surgery or filling therapy in the eyebrow/nose area during the study period; 11. Those who have participated or are currently participating in clinical trials of drugs or devices within the past month; 12. Female patients during pregnancy or lactation, or those who plan to commit adultery during the study period; 13. Other situations that the researcher deems unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in nasal dorsum and/or nasal root volume relative to baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in nasal dorsum and/or nasal root volume relative to baseline at other follow-up points;Changes in nasal dorsum height relative to baseline;Changes in nasal frontal angle relative to baseline ;Evaluate the Global Beauty Effect (GAIS) score;Pain Visual Analog Scale (VAS) scores; | — |
Countries
China
Contacts
Public ContactZhao Hongyi
Beijing Hospital
Outcome results
None listed