Poor skin quality
Conditions
Interventions
Experimental group:Facial injection of a mixed solution of collagen implant and normal saline
Control group:None
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years and <= 65 years, gender; 2. Have a need for temporary improvement of facial skin condition such as dry skin, dull complexion.; 3. Skin Fitzpatrick type II-IV; 4. Voluntarily participate in this clinical trial and have signed the informed consent form; 5. Agree to maintain existing skin care habits and not use other beauty treatments related to the study during the research period.
Exclusion criteria
Exclusion criteria: 1. Those prone to keloid, hypertrophic scar or any other healing abnormalities; 2. Those allergic to the drugs involved in the trial such as local anesthetics like lidocaine or other amide-type anesthetics., the trial products such as collagen, bovine-derived materials, etc;., or in the midst of an allergic reaction; 3. Those with coagulation disorders APTT > 1;5 times the upper limit of the normal value of the testing institution.; autoimmune diseases such as systemic lupus erythematosus, scleroderma, etc;.; severe heart, liver or kidney diseases; uncontrolled diabetes; 4. Those with facial tattoos, scars, deformities, unhealed wounds, active skin diseases or skin inflammation, or facial skin infectious diseases such as eczema, acne, contact dermatitis, atopic dermatitis, herpes simplex, psoriasis, shingles, vitiligo, etc;., cancer or precancerous lesions that may affect the evaluation of treatment efficacy or increase treatment risks; 5. Those who have received any permanent or semi-permanent fillers such as hydroxyapatite calcium, poly-L-lactic acid, polymethyl methacrylate, silicone, expanded polytetrafluoroethylene, polycaprolactone, etc;., autologous fat, or facial lifting procedures including thread lifting. within the past two years; 6. Those who have received cross-linked hyaluronic acid or collagen injections or other temporary fillers within the past 12 months; 7. Those who have undergone facial surgery or cosmetic procedures such as botulinum toxin injections, fractional laser, radiofrequency treatment, ultrasound treatment, chemical peels, dermabrasion, non-cross-linked hyaluronic acid injections, intense pulsed light, photorejuvenation, etc;. within the past six months, or have received systemic retinoid treatment; 8. Those who have received local retinoid or corticosteroid treatment within the past month in the trial area; 9. Those who have received any thrombolytic, anticoagulant or antiplatelet drugs such as warfarin, aspirin, etc;. within the past two weeks; 10. Those currently undergoing chemotherapy/radiotherapy; 11. Those who work outdoors for long periods or need to be exposed to sunlight after the procedure; 12. Those with unknown injectable substances in the treatment area; 13. Those with overly high expectations for treatment outcomes; 14. Pregnant women, lactating women, and those with plans to conceive during the trial period; 15. Those who are currently using or are expected to continue using photosensitive drugs during the study period; 16. Those with cognitive or mental disorders that prevent them from understanding and cooperating; 17. Those who have participated in other clinical trials within the past month before signing the informed consent; 18. Those deemed unsuitable for participation in this clinical trial by the investigator;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effective rate of GAIS improvement (assessed by blinded evaluators);The effective rate of skin improvement; | — |
Secondary
| Measure | Time frame |
|---|---|
| Global Aesthetic Improvement Score (GAIS) Evaluation;Evaluation of the Improvement Effect on Dull Skin Tone;Subject satisfaction score;Skin moisture;Skin elasticity;Fine line scale;Skin Roughness Scale;A comprehensive scale reflecting temporary improvement in skin dryness and dull complexion.; | — |
Countries
China
Contacts
Public ContactWang Chengyuan
China-Japan Friendship Hospital
Outcome results
None listed