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A prospective, multicenter, randomized, treatment-controlled, double-blind, superiority clinical trial to evaluate the efficacy and safety of sodium hyaluronate injection gel

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106420
Enrollment
Unknown
Registered
2025-07-23
Start date
2023-10-13
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

Dry skin and dull complexion in adults

Interventions

Sponsors

Plastic Surgery Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 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 Gel for Injection therapy for injection to improve their skin condition; 3. Presence of at least one of the following facial characteristics: dull complexion, dryness, enlarged pores, 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 severe allergic reactions or anaphylactic shock; 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 value (ULN)), or those who had received any thrombolytic agents, anticoagulants or antiplatelet drugs (such as warfarin, aspirin, etc.) within one week before enrollment; 4. Those who had undergone facial surgery within 6 months before enrollment and were determined by the researchers that it would interfere with the evaluation of clinical efficacy; 5. The face has received any permanent fillers (such as polymethyl methacrylate, silicone, expanded polytetrafluoroethylene, etc.), autologous fat, facial lifting surgery (including thread lifting), etc. 6. The face had received more than half of the permanent fillers (such as calcium hydroxyapatite, poly-L-lactic acid, polycaprolactone, etc.) within 2 years before enrollment; 7. The face had received cross-linked hyaluronic acid or collagen injection therapy or other temporary fillers in the 12 months before enrollment, or the face had received non-cross-linked hyaluronic acid in the 6 months before enrollment. Or the face has received any anti-wrinkle treatment (such as botulinum toxin injection, radiofrequency therapy, ultrasound therapy, dermabrasion, etc.) within 6 months before enrollment, or the face has received laser or chemical dermabrasion within 1 month before enrollment, etc.; 8. Have received chemotherapy, immunosuppressants, immunomodulatory therapy (such as monoclonal antibodies, etc.) or systemic corticosteroids (except inhaled corticosteroids) within 6 months before enrollment; 9.There are tattoos, scars, deformities, unhealed wounds, systemic or topical medications in the face of treatment Retinoid drugs, active skin diseases or skin inflammation or facial skin infectious diseases (such as rosacea, eczema, acne, contact dermatitis, seborrheic dermatitis, atopic dermatitis, herpes simplex, psoriasis, shingles, vitiligo, etc.), cancer or precancerous lesions, etc. that may affect the evaluation of therapeutic effect or increase the risk of treatment;10. Subjects prone to developing keloids or hypertrophic scars; 11. Have a history of active autoimmune diseases or diseases (such as systemic lupus erythematosus, rheumatoid arthritis, scleroderma, dermatomyositis, etc.); 12. Those with the following diseases, as determined by the researcher, are not suitable for inclusion: those with malignant tumors or severe dysfunction of important organs (such as brain, heart, lung, 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 (serum Alanine Aminotransferase (ALT), serum Aspartate Aminotransferase (AST)>2 times ULN), and abnormal renal functi

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 ContactYan Yan

Plastic Surgery Hospital, Chinese Academy of Medical Sciences

yanyan@psh.pumc.edu.cn+86 10 5396 8000

Outcome results

None listed

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