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A prospective, multicenter, randomized, blinded, superiority clinical trial to evaluate the efficacy and safety of sodium hyaluronate solution for injection in improving facial skin condition.

A prospective, multicenter, randomized, blinded, superiority clinical trial to evaluate the efficacy and safety of sodium hyaluronate solution for injection in improving facial skin condition.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119641
Enrollment
Unknown
Registered
2026-03-02
Start date
2023-10-31
Completion date
Unknown
Last updated
2026-03-09

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

Conditions

skin condition

Interventions

Sponsors

Zhejiang Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 18–65 years inclusive (both inclusive); 2. Individuals seeking temporary improvement in facial skin dryness, dull complexion, and skin elasticity; 3. Skin Fitzpatrick type II–IV; 4. Voluntary participation in this trial and signing of the informed consent form; 5. Be willing to maintain the current skin care habits and not use other cosmetic treatments related to the study during the study period.

Exclusion criteria

Exclusion criteria: 1. Prone to keloid, hypertrophic scar, scar constitution or any other healing abnormality; 2. Allergic to the drugs involved in the trial (such as local anesthetic lidocaine or other amide narcotic drugs), the test products (hyaluronic acid), or known history of hypersensitivity reactions; 3. Coagulation dysfunction (APTT>1.5× ULN); Immune system diseases (such as systemic lupus erythematosus, scleroderma, etc.); Severe heart, liver and kidney diseases; 4. Skin diseases with active or advanced stage or isomorphous reaction in the treatment area, such as acute eczema, verruga plana, lichen planus, psoriasis vulgaris, etc. 5. Skin infection (including viral, bacterial, fungal), skin granuloma, malignant tumor or unknown skin mass in the treatment area, and unknown injection in the treatment area; 6. Receiving chemotherapy/radiotherapy; 7. Received any permanent or semi-permanent fillers (such as hydroxyapatite calcium, poly (L-lactic acid), polymethyl methacrylate, silicone, expanded polytetrafluoroethylene, polycaprolactone, etc.), autologous fat, and facial lifting surgery (including catgut-embedding) within 2 years; 8. Received other temporary fillers such as cross-linked hyaluronic acid or collagen injection therapy within 12 months; 9. Underwent facial surgery or cosmetic surgery, such as botulinum toxin injection, laser fractional therapy, radiofrequency therapy, ultrasound therapy, chemical exfoliation, skin dermabrasion, non-crosslinked hyaluronic acid injection, intense pulsed light, photon rejuvenation, etc. and received systemic retinoic acid treatment within 6 months; 10. Treatment with topical retinoic acid or corticosteroid in the trial area within 1 month; 11. Received any thrombolytic, anticoagulant or antiplatelet therapy (such as warfarin, aspirin, etc.) within 2 weeks; 12. Pregnant or lactating women and those who planned to have children during the study period; 13. Be known to be continuously using or expected to continue using photosensitive drugs or other treatments during the study; 14. Worked outdoors for a long time or needed to remove sunlight after surgery; 15. Combined with cognitive impairment or mental disorder, unable to understand and cooperate; 16. With too high expectation of treatment effect; 17. Participated in other clinical trials within 3 months before signing the informed consent; 18. Deemed by the investigator to be ineligible to participate in the trial.

Design outcomes

Primary

MeasureTime frame
Improvement Rate on the Comprehensive Scale for Transient Alleviation of Skin Dryness and Dullness;Improvement rate of Allergan Skin Roughness Scale;

Secondary

MeasureTime frame
Global Aesthetic Improvement Scale (GAIS);Evaluation of skin dullness improvement effect;Subject Satisfaction Scores;Allergan Fine Lines Scale (evaluated by blinded investigator);Allergan Skin Roughness Scale (evaluated by blinded investigator);the Comprehensive Scale for Transient Alleviation of Skin Dryness and Dullness;skin moisture content;skin elasticity;

Countries

China

Contacts

Public ContactWu Sufan

Zhejiang Provincial People's Hospital

sufanwu@hotmail.com+86 571 8523 9988

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026