improving facial skin condition
Conditions
Interventions
Experimental group:inject recombinant type III humanized collagen
Control group:No-treatment controlled
Sponsors
Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age is 18~70 (inclusive), gender is not limited; 2. The skin type is Fitzpatrick skin classification type II to V; 3. The subjects need to improve facial skin condition, and (as assessed by blind researchers) skin dryness score of 1-4; 4. The subjects voluntarily participated in this trial and signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) With acute or advanced skin diseases (such as active acne, acute eczema, contact dermatitis, acute atopic dermatitis, psoriasis and other inflammatory diseases, vitiligo, etc.), active skin infections, herpes, open wounds, streptococcal infection history, or tumors at the injection site of the face; (2) The face has received any permanent or semi-permanent filler or planned to receive fillers during the study period; (3) Within 6 months before enrollment, the face have received comprehensive plastic surgery or other cosmetic procedures that may affect the efficacy score of facial injections (such as facial lift surgery, botulinum toxin injection, etc.); (4)Those who had received facial injections of sodium hyaluronate or collagen in the 12 months prior to screening; (5) Have a history of severe allergies or allergies to collagen, lidocaine and local anesthesia drugs (6) Those who had scar diathesis or could not guarantee to quit smoking during the trial (7) Those who with bleeding tendency or who have been treated with thrombolysis agents, anticoagulants (such as heparin, warfarin, sodium citrate, aspirin, etc.) or platelet clotting inhibitors within 2 weeks, or with autoimmune diseases (such as rheumatism, lupus erythematosus, etc.), immune dysfunction, diabetes, or serious systemic diseases such as malignant tumors; (8) Platelet count less than 50×109/L or with abnormal coagulation mechanisms during the screening period (activated partial thromboplastin time (APTT)>1.5 times the upper limit of normal values); (9) With clinically significant liver and kidney function abnormalities (AST, ALT or Cr > 1.5 times the upper limit of normal) during screening (10) Those who had been infected with the COVID-19 within 7 weeks prior to screening (11) Those who with mental disorders can't cooperate; (12) Women who are pregnant or lactating, or have plans to have children during the research period; (13) Those who have participated in other interventional clinical trials in the past month; (14) The researcher evaluates subjects who are not suitable to participate in this trial due to other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the improvement effective rate of Global Aesthetic Improvement Scale(GAIS),dry skin and dark skin when 4 weeks after the last injection; | — |
Secondary
| Measure | Time frame |
|---|---|
| Facial skin moisture content before and after injection;Global Beauty Effect (GAIS) score, skin dryness score, skin tone score (except 4 weeks after the last injection) were evaluated by blind investigators;The injection investigators evaluated the global aesthetic effect (GAIS) score, skin dryness score, and skin dullness score.;Subjects rated Global Beauty Effect (GAIS) score, skin dryness score and skin dullness score;Satisfaction evaluation by the subjects; | — |
Countries
China
Contacts
Public ContactYixin Zhang
Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed