wrinkle
Conditions
Interventions
control group:M22 (ResurFX Laser Handpiece)
Sponsors
Hospital of Dermatology, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Healthy adults aged 18-65 (including 18 and 65 years old), regardless of gender; 2) Fitzpatrick skin types II to IV; 3) Mild to moderate periorbital wrinkles, with a Fitzpatrick wrinkle score of 3-6 (including 3 and 6); 4) Voluntarily accept laser treatment and cooperate with follow-up; 5) Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) The subject refuses to sign the informed consent; 2) Those who are sensitive to near-infrared light; 3) Those who have a recent history of sun exposure; 4) Those who have taken drugs known to affect wound healing; 5) Those with a history of photosensitive epilepsy; 6) Those with a history of squamous cell carcinoma or melanoma; 7) Those with a history of skin healing disorders or keloids, vitiligo or psoriasis; 8) Abnormal coagulation function tests or a history of coagulation disorders or the use of anticoagulants; 9) There is active local or systemic infection, or there is an open wound in the area to be treated; 10) Women who are pregnant or breastfeeding or plan to become pregnant during the study period; 11) Suffering from uncontrolled diabetes and other diseases that may interfere with the anesthesia, treatment or healing process; 12) Patients in the attack period of herpes simplex (can be given treatment after preventive treatment); 13) Those who currently have chloasma or post-inflammatory hyperpigmentation in the treatment area; 14) Has received fruit acid superficial chemical peeling within 1 month; 15) Received dermabrasion treatment within 3 months; 16) Botox has been injected in the treatment area within half a year; 17) Participated in or is currently participating in other drug or medical device clinical trials within three months; 18) Any kind of open tear or abrasion, tattoo on the treatment site; 19) Subjects considered by the investigator to be unsuitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Facial Fitzpatrick Wrinkle Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS score;Subject Satisfaction;Product Performance Evaluation; | — |
Countries
China
Contacts
Public ContactLin Tong
Hospital of Dermatology, Chinese Academy of Medical Sciences
Outcome results
None listed