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Efficacy and safety of nasal injection filling

Multicenter, randomized, treatment-free clinical trials to evaluate the efficacy and safety of injectable hydroxyapatite gel for nasal injectable filling

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087422
Enrollment
Unknown
Registered
2024-07-26
Start date
2024-07-30
Completion date
Unknown
Last updated
2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Defects of nasal volume and morphology

Interventions

Treatment group:Inject hydroxyapatite gel
Control Group:None

Sponsors

Chongqing Xingrong Plastic Surgery Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age =18 years old; 2.The subject's subjective desire for external nasal morphology improvement and the treatment investigator (TI) believes that this goal can be achieved after injection; 3. 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 protocol.

Exclusion criteria

Exclusion criteria: 1.Pregnant, nursing and puerperal women and those who have a pregnancy plan within the last 1 year; 2.there are serious mental disorders, psychological disorders, personality disorders or are taking antipsychotic drugs; 3.Patients with autoimmune diseases, or taking hormone drugs, or suffering from serious underlying diseases such as malignant tumors and tuberculosis; 4.diabetes mellitus; 5. There are serious diseases of important organs (cardiovascular system, lung, liver, kidney and nervous system, etc.); 6.Patients with coagulation dysfunction who have received thrombolysis, anticoagulation, and anti-platelet aggregation treatment within 2 weeks before injection, or who need to receive the above treatment within 2 weeks after injection; 7.cicatricial constitution (easy to form hypertrophic scars or keloids); 8.Allergic to hydroxyapatite or any component of this product (carboxymethyl cellulose, glycerin), 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; 9. congenital or acquired injury caused by nasal deformity or defect; 10.Nasal skin diseases (such as skin inflammation, increased or decreased pigmentation); 11.Complicated with serious nasal diseases, such as severe allergic rhinitis, chronic atrophic rhinitis, turbinate hypertrophy, etc.; Nasal function diseases, such as smelly nose, phantom smell and other smell abnormalities; 12.external nasal area infection or systemic infection is not controlled, or the external nasal area has a history of chronic or recurrent infection (such as herpes) or inflammation, or unhealed wounds, pre-cancerous lesions or cancerous changes; 13.Patients who have undergone surgery or injection for nasal filling and plastic surgery; 14. have received or plan to receive permanent/semi-permanent/temporary implants or fat implants in the area adjacent to the external and internal nose in the past 12 months; 15. have received or plan to receive botox therapy, laser, radiofrequency, exfoliative therapy, or plastic therapy in the past 6 months or in the area adjacent to the external nose during the study period; 16.Plan to have a significant weight change (more than 10% of body weight) during the study period; 17. Participants in any other clinical trial within 30 days before signing the informed consent; 18.There are people who are judged by other researchers as not suitable for participating in this clinical trial.

Design outcomes

Primary

MeasureTime frame
External nasal area volume;

Countries

China

Contacts

Public ContactLi Shirong

Chongqing Xingrong Plastic Surgery Hospital

lishirong@xingrong.com+86 67047983

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026