Dry facial skin and dull complexion
Conditions
Interventions
A group:Facial Injection Sodium Hyaluronate Solution for Injection (Control Device)
B group:Sodium Hyaluronate Solution for Injection (Investigational Device)
Sponsors
Jiangxi Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 65, no gender restrictions; 2.Subjects with the demand for temporary improvement of facial skin dryness and dull complexion; 3.Skin Fitzpatrick classification type II-IV; 4.Subjects who agree not to receive other beauty treatments related to the study during the research period; 5.The subjects are informed of this trial, voluntarily participate in this study, and have signed the informed consent form;
Exclusion criteria
Exclusion criteria: 1.Known hypersensitivity to hyaluronic acid products or phosphates; hypersensitivity to topical anesthetics (e.g., lidocaine or other amide-based anesthetics); or a history of severe allergies or anaphylactic shock; 2.Patients with moderate to severe folliculitis or acne; 3.Significant scarring or extensive acne lesions in the trial treatment area; active, progressive, or isomorphic skin conditions such as acute eczema, flat warts, lichen planus, or psoriasis vulgaris; local skin infections (including viral, bacterial, or fungal infections) in the trial area; 4.Keloid predisposition or presence of cutaneous granulomas; 5.Immune system disorders; 6.Uncontrolled hypertension, diabetes mellitus (fasting blood glucose =8.5 mmol/L), hyperthyroidism, or hypothyroidism; 7.Coexisting coagulation disorders or other systemic diseases; 8.Malignant tumors or unidentified skin masses in the treatment area; 9.Patients undergoing chemotherapy/radiotherapy; 10.Patients with psychiatric disorders or emotional instability; 11.Pregnant or breastfeeding women, or those planning pregnancy during the study; 12.Individuals engaged in prolonged outdoor work or requiring significant sun exposure post-surgery; 13.Presence of unknown injectable substances in the treatment area; 14.Excessive expectations regarding therapeutic efficacy; 15.History of similar treatments within 6 months (including radiofrequency, phototherapy, or botulinum toxin injections in the treatment area); 16.Laboratory findings deemed clinically significant upon re-evaluation by investigators. 17.Subjects deemed unsuitable for participation in this clinical trial by the investigators;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effective response rate of the Global Aesthetic Improvement Scale (GAIS) score assessed by evaluators at Week 12 (+/-5 days) after the first injection treatment;The evaluators assess the effective response rate of the comprehensive score for improvements in skin dryness and dull complexion (DDIS) of subjects at Week 12 (±5 days) after the initial injection tr; | — |
Secondary
| Measure | Time frame |
|---|---|
| GAIS scores assessed by the subjects themselves, comparing with baseline images, at week 4 (+/-5 days) and week 8 (±5 days) before injection treatment, and at week 12 (+/-5 days) after the first injection treatment.;Perform a test for the subject's skin dryness at week 4 (+/-5 days) and week 8 (+/-5 days) before the injection, and at week 12 (+/-5 days) after the first injection treatment.;The evaluator assesses the overall aesthetic effect (GAIS) before the injections at week 4 (+/-5 days) and week 8 (+/-5 days) after the first injection, comparing with baseline images to calculate the response rate.;DDIS scores of subjects before the injection at week 4 (+/-5 days) and week 8 (+/-5 days) after the first injection, as assessed by the evaluator;The evaluator rates the improvement in the subject's dull skin at week 4 (+/-5 days) and week 8 (±5 days) before the injection, and at the follow-up at week 12 (+/-5 days) after the first injection treatment.;Participants rated their satisfaction at week 4 (+/-5 days) and week 8 (+/-5 days) after the injection, before getting the next injection, and at week 12 (+/-5 days) after the first injection.; | — |
Countries
China
Contacts
Public ContactLiu Cheng
Jiangxi Provincial People's Hospital
Outcome results
None listed