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A multicenter, randomized, no-treatment controlled clinical trial to evaluate the efficacy and safety of crosslinked sodium hyaluronate gel for injection

A multicenter, randomized, no-treatment controlled clinical trial to evaluate the efficacy and safety of crosslinked sodium hyaluronate gel for injection

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084000
Enrollment
Unknown
Registered
2024-05-08
Start date
2024-05-10
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

Volume deficit

Interventions

Treatment group:Inject crosslinked sodium hyaluronate 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, male or female; 2) The researchers judged that the bilateral mandibular line had moderate to severe lack of clarity and hoped to improve it; 3) The investigators considered that after injection, the subjects could achieve improved mandibular line clarity compared with baseline mandibular line score; 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 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) 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) Those who have the following previous treatments or plan to receive the following treatments during the study period in the jaw or adjacent area: Have undergone surgery (including lift surgery, liposuction), permanent implants (e.g., polymethyl methacrylate, silicone, teflon), fat filler or lift wire implantation; Semi-permanent fillers (such as hydroxyapatite and poly-L-lactic acid) were injected within 3 years before enrollment. Temporary fillers (such as hyaluronic acid and collagen) were injected within 12 months before enrollment. 9) Participants in any other clinical trial within 30 days before signing the informed consent; 10) There are people who are judged by other researchers as not suitable for participating in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Contour improvement efficiency;

Secondary

MeasureTime frame
GAIS;Numerical rating scale, NRS;

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