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A prospective, multicenter, randomized, treatment-controlled, double-blind, superiority clinical trial to evaluate the efficacy and safety of Sodium Hyaluronate Compound Solution for Injection

A prospective, multicenter, randomized, treatment-controlled, double-blind, superiority clinical trial to evaluate the efficacy and safety of Sodium Hyaluronate Compound Solution for Injection

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107291
Enrollment
Unknown
Registered
2025-08-07
Start date
2024-01-08
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

improve dry skin and dull complexion in adults

Interventions

Sponsors

The Seventh Medical Center of the Chinese People's Liberation Army General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Subjects who are between 18 and 60 years, with no gender restriction; 2. Subjects who are willing to undergo Sodium Hyaluronate Compound Solution Gel for Injection therapy for injection to improve their skin condition; 3. Those with facial skin that has one of the following characteristics: dull complexion, dryness, enlarged pores, slightly poor elasticity, or fine wrinkles; 4. Voluntary signing of the informed consent form, acknowledgment and acceptance of the study duration, and commitment to adhere to all study requirements, including treatment administration, follow-up visits, and other planned procedures; 5. Be willing to maintain the current skin care habits during the research period.

Exclusion criteria

Exclusion criteria: 1. There is a known allergy to hyaluronic acid products or any component in this product, or to any local anesthetic drugs (such as lidocaine or other amide anesthetic drugs), or a known history of hypersensitivity reactions; 2. Subjects who are known to be continuously using or are expected to continue using photosensitive drug treatment during the study period; 3. Subjects with abnormal coagulation mechanisms during the screening period (Activated Partial Thromboplastin Time (APTT) >1.5 times the Upper Limit of Normal values (ULN)), or those who have received any thrombolytic agents, anticoagulants or antiplatelet drugs (such as warfarin, aspirin, etc.) within 2 weeks before enrollment; 4. Those who had undergone facial surgery within 6 months before enrollment; 5. The face has received any permanent fillers (such as polymethyl methacrylate, poly-l-lactic acid, silicone, expanded polytetrafluoroethylene, polycaprolactone, etc.), autologous fat, facial lifting surgery (including thread lifting), etc.; 6. The face has received other temporary fillers such as cross-linked hyaluronic acid or collagen injection treatment within 12 months before enrollment, or the face has received non-cross-linked hyaluronic acid within 6 months before enrollment, or the face has received any anti-wrinkle treatment (such as botulinum toxin injection, radiofrequency therapy, ultrasound therapy, laser or chemical exfoliation, dermabrasion, etc.) within 6 months before enrollment; 7. Have received chemotherapy, immunosuppressants, immunomodulatory therapy (such as monoclonal antibodies, etc.) or systemic corticosteroids (except inhaled corticosteroids) within 6 months before enrollment; 8. There are tattoos, scars, deformities, unhealed wounds, active skin diseases or skin inflammations, or facial skin infectious diseases (such as eczema, acne, contact dermatitis, atopic dermatitis, herpes simplex, psoriasis, shingles, vitiligo, etc.), cancer or precancerous lesions on the face that may affect the evaluation of therapeutic effect or increase the risk of treatment; 9. Subjects prone to developing keloids or hypertrophic scars; 10. Have a history of active autoimmune diseases or diseases (such as systemic lupus erythematosus, rheumatoid arthritis, scleroderma, dermatomyositis, etc.); 11. As determined by the researchers, those accompanied by malignant tumors or severe functional insufficiency of important organs (such as the brain, heart, lungs, liver, renal, etc.), Such as severe cardiovascular and cerebrovascular diseases (hospitalization due to myocardial infarction or heart surgery within 3 months, history of congestive heart failure or myocardial infarction, severe unstable arrhythmia, hypertrophic cardiomyopathy, severe aortic stenosis, aneurysm, stroke, etc.), severe lung diseases (moderate to severe pneumonia, respiratory failure, etc.), uncontrolled diabetes, epilepsy, abnormal liver function ( ALT, AST>2 times ULN), and abnormal renal function (Creatinine (Cr)>1.5 times ULN); 12. Women who are pregnant or lactating, or those planning to become pregnant during the study period; 13. Those who have participated in within the past month or are currently participating in clinical trials of drugs or devices; 14. Other circumstances that the researcher deems unsuitable for participating in this trial.

Design outcomes

Primary

MeasureTime frame
The effective rate of treatment one month after the last injection (evaluated by blinded investigator);

Secondary

MeasureTime frame
The effective rate of treatment one month after the first injection, one month after the second injection, and three months after the last injection (evaluated by blinded investigator).;The effective rates of treatment one month after the first injection, one month after the second injection, and one and three months after the last injection (evaluated by injection investigator and subjects).;The improvement of physiological indicators of the skin;

Countries

China

Contacts

Public ContactYang Rongya

The Seventh Medical Center of the Chinese People's Liberation Army General Hospital

yangrya@sina.com+86 10 6672 1629

Outcome results

None listed

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