Forehead wrinkles, crow's feet
Conditions
Interventions
Test group:Randomly assign half of each subject's face to the test side and the control side
apply serum according to the randomization results
in the test gro
Control group:Randomly assign half of each subject's face to the test and control sides
apply the appropriate serum according to the randomization results
in the
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
Female
Age
35 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Non-smoking women aged 35-55 years; 2.Accompanied by moderate forehead fine lines (Skin Aging Atlas, scale 1-4); 3.With moderate to severe crow's feet and forehead lines (Facial Wrinkle Scale score of 2-3 on face-to-face assessment, consistent bilaterally); 4.Skin typing as Fizpatrick II-IV; 5.Subjects with no significant bilateral facial asymmetry (face-to-face assessment); 6.Subjects voluntarily sign an informed consent form and agree to complete the treatment and follow-up as specified in the trial;
Exclusion criteria
Exclusion criteria: 1.Subjects with facial scarring or skin disorders that may affect the determination of treatment efficacy, in the midst of an allergic attack, or in the presence of active infections (e.g., inflammatory acne, herpes simplex, etc.), and/or unhealed wounds, and in the midst of progressive skin diseases such as vitiligo, psoriasis, etc. 2.Screening criteria exclude planned full-face surgery or treatment prior to screening or during the study period for any of the following procedures or treatments affecting the trial: silicone implants, autologous fat grafting, facelift, submerged thread lifts, permanent dermal fillers, semi-permanent dermal fillers within the 18 months prior to screening or during the study period, degradable dermal fillers within the 12 months prior to screening or during the study period, Botulinum toxin, non-ablative fractional lasers, dermabrasion, medium-depth chemical peels and other ablative treatments, and minor ablative treatments such as intense pulsed light and superficial peels within 3 months prior to screening or during the study perioding or during the study periodght and superficial peels wit; 3.Aspirin and aminoglycoside antibiotics within 2 weeks before and after injection; 4.Known hypersensitivity to Clostridium botulinum toxin type A and to any of the ingredients in the formula. 5.Patients with myasthenia gravis or myasthenia gravis syndrome; 6.Women who are pregnant or breastfeeding, or intend to plan a pregnancy during the trial period; 7.Subjects with other systemic diseases that, in the judgment of the investigator, make them unsuitable for participation in this trial; 8.Subjects who are unable to communicate or do not follow instructions; 9.Other conditions that, in the opinion of the investigator, make participation in this trial inappropriate;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of forehead fine lines in subjects at week 12; | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of improvement of dynamic forehead wrinkles during maximal eyebrow lifting based on the 4-category Facial Wrinkle Scale was assessed on-site by a blinded assessment investigator at different;Improvement rate of crow's feet at maximum smile based on the 4-category Facial Wrinkle Scale (FWS) at different follow-up nodes, as assessed on-site by a blinded assessment investigator;Changes in static forehead wrinkle scores based on the Skin Aging Atlas as assessed on-site by a blinded assessment investigator at different follow-up nodes;Changes in static under-eye wrinkle scores based on the Skin Aging Atlas as assessed on-site by a blinded assessment investigator at different follow-up nodes;Improvement of forehead wrinkles, crow's feet and under-eye wrinkles in subjects analyzed based on PRIMOS 3D Digital Photo;Improvement of facial wrinkles in subjects analyzed based on PRIMOS 3D Digital Photo at different follow-up nodes;Improvement in skin elasticity, skin firmness, facial and frontal radiance, and oil on the cheeks of subjects collected by the Multi-Purpose Skin Tester at different follow-up points, compared to base;Improvement in red zone, pore, wrinkle and texture index parameters of the subject's face collected by the VISIA Skin Tester compared to baseline at different follow-up points;At different follow-up nodes, blinded assessment investigators assessed the rate of improvement in global cosmetic scores;At different follow-up nodes, subjects were assessed for the rate of improvement in bilateral frontal and periocular global cosmetic scores; | — |
Countries
China
Contacts
Public ContactYan Wu
Peking University First Hospital
Outcome results
None listed