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A multicenter, randomized, placebo-controlled, blinded, superiority clinical trial evaluating the efficacy and safety of sodium hyaluronate injection complex solution for improving skin condition

A multicenter, randomized, placebo-controlled, blinded, superiority clinical trial evaluating the efficacy and safety of sodium hyaluronate injection complex solution for improving skin condition

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099220
Enrollment
Unknown
Registered
2025-03-19
Start date
2023-08-03
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

Improve facial skin condition

Interventions

Test group:Injection of Sodium Hyaluronate Composite Solution
control group:NA

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Participants in this clinical trial must meet all of the following criteria: (1) Male and female participants aged 18 to 65 years old (including 18 and 65 years old); (2) Those who are willing to undergo injection therapy with sodium hyaluronate composite solution for temporary improvement of facial skin dryness and dullness; (3) Skin Fitzpatrick classification is II-IV; (4) Agree not to use any other cosmetic treatments related to the study during the research period; (5) Willing to maintain existing skincare habits during the research period; (6) Voluntarily sign the informed consent form, understand and accept the duration of the study, and be able and willing to comply with all requirements, including treatment, follow-up, and other research procedures as planned.

Exclusion criteria

Exclusion criteria: If a subject meets any of the following exclusion criteria, they cannot be enrolled in this study: 1. Known to be allergic to hyaluronic acid products or any ingredients in this product, streptococcal protein, or to any local anesthetic drugs (such as lidocaine or other amide anesthetics), or known to have a history of hypersensitivity reactions; 2. Subjects who have received any permanent fillers (such as polymethyl methacrylate) on their face; 3. Subjects who are known to be continuously using or expected to continue using photosensitive drugs during the study period; 4. Subjects with abnormal coagulation mechanism (APTT>1.5 times the upper limit of normal value), abnormal liver function (ALT, AST>2 times the upper limit of normal value), and abnormal kidney function (SCr>1.5 times the upper limit of normal value); 5. Subjects who test positive for human immunodeficiency virus (HIV) antibodies, hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or Treponema pallidum antibodies (Anti TP); 6. Subjects who have received hyaluronic acid or collagen injection therapy or other semi permanent filling, facial lifting surgery (including thread embedding), or other surgeries within the past 12 months prior to enrollment; Within 6 months prior to enrollment: receive chemotherapy, immunosuppressants, immunomodulatory therapy (such as monoclonal antibodies), or systemic corticosteroids (excluding inhaled corticosteroids) treatment; Subjects undergoing any facial cosmetic treatment (such as botulinum toxin injection, radiofrequency therapy, ultrasound-guided, laser, skin contouring, etc.); 8. Participants who have participated in other clinical trials within one month prior to enrollment; 9. Subjects who have used any thrombolytic, anticoagulant, or antiplatelet drugs (such as warfarin, aspirin, etc.) within 2 weeks prior to enrollment; 10. Subjects who have scars, deformities, unhealed wounds, skin infectious diseases (such as viruses, bacteria, fungi) that may affect the efficacy evaluation or increase the treatment risk, active or progressive skin diseases or skin diseases with similar reactions in the treatment area, such as acute eczema, verruca plana, lichen planus, psoriasis vulgaris, skin granuloma, canceration or precancerous lesions, keloids or hypertrophic scars or keloid constitution, or combined with collagen connective tissue diseases, and unknown injections in the treatment area; 11. People with malignant tumors or serious dysfunction of important organs (such as brain, heart, lung, liver, kidney, etc.), diabetes, active autoimmune diseases or medical history (such as systemic lupus erythematosus, rheumatoid arthritis, scleroderma, dermatomyositis, etc.); 12. Subjects in the stage of allergic disease (such as asthma, urticaria, etc.) attacks; 13. Long term outdoor work or postoperative exposure to sunlight; 14. Those who have high expectations for the treatment effect; 15. Pregnant and lactating women; 16. Female participants of childbearing age do not agree to use medically recognized contraceptive measures (such as oral contraceptives, condoms, intrauterine devices, etc.) during the trial period; 17. Other situations deemed unsuitable for participation in this experiment by the researchers.

Design outcomes

Primary

MeasureTime frame
Skin improvement situation;

Secondary

MeasureTime frame
Subject satisfaction evaluation;Improvement of skin physiological indicators - Moisture content ;

Countries

China

Contacts

Public ContactWang Chengyuan

China-Japan Friendship Hospital

zryhyyent@126.com+86 185 1838 1162

Outcome results

None listed

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