Cutis Laxa
Conditions
Interventions
experimental group:blunt needle linear injection
control group:sharp needle punctate injection
Sponsors
Peking Union Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
Female
Age
30 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1) Women between the ages of 30 and 55; 2) The investigator judged that the subject's facial skin is dry, rough, and has obvious fine lines, and the Lemperle wrinkle grade is grade II or above, which can be improved by trial device treatment; 3)Subjects who need to improve dry skin and fine lines on the face; 4)The subject voluntarily and signed the informed consent form, and agreed to complete the follow-up visits specified by the trial. Note: All the above criteria are eligible for inclusion
Exclusion criteria
Exclusion criteria: (1) The subject has facial scars or skin diseases that may affect the judgment of the treatment effect, is in the allergy attack stage, or has active infection (such as inflammatory acne, herpes simplex, etc.), and/or unhealed wounds, and is in the advanced stage of skin diseases such as vitiligo, psoriasis, etc.; (2) Received or planned to have the following surgeries or treatments affecting this trial prior to screening or planned during the study period: a) Before screening or during the study period, it is planned to be carried out in the whole department: silicone, autologous fat grafting, face lift surgery, thread lift, permanent dermal filler (such as polymethyl methacrylate, etc.) treatment and other surgical treatments to improve facial wrinkles; b) 18 months prior to screening or planned in the comprehensive department during the study period: semi-permanent dermal filler treatment (such as poly-L-lactic acid, hydroxyapatite, polycaprolactone, etc.); c) 12 months prior to screening or planned in the full part during the study period: degradable dermal filler (such as sodium hyaluronate gel or collagen, etc.) treatment; d) 6 months before screening or planned to be performed in the whole department during the study period: botulinum toxin, mesotherapy, energy devices (such as laser, radio frequency, ultrasound, etc.) other than photomodulation therapy and intense pulsed light, dermabrasion, chemical peels of medium or greater depth or other ablative treatments (such as trichloroacetic acid, carbolic acid, 10% and above concentration of fruit acid or 2% or more concentration of salicylic acid, etc.); e) 3 months before screening or planned to be carried out in the comprehensive part during the study period: photomodulation therapy, intense pulsed light, superficial decortication or other ablative treatments (such as less than 10% concentration of AHA or less than 2% concentration of salicylic acid, etc.); (3) Multiple history of severe allergies to any part of the body, history of hereditary allergies, those who plan to undergo desensitization treatment during the study period, or subjects who are allergic to the components of drugs or devices used in the trial treatment method (hyaluronic acid, streptococcal protein, lidocaine or other amide anesthetics, etc.); (4) Subject has a history of coagulation dysfunction, or has used or plans to use anticoagulant, antiplatelet or thrombolytic therapy (such as warfarin, aspirin, etc.) within 14 days prior to screening; (5) Pregnant or breastfeeding, planning to become pregnant during the trial, or having a positive pregnancy test result during the screening period; (6) Subject has a history of serious disease of important organs or active autoimmune disease; (7) Those with hypertrophic scars or scar constitution; (8) Subjects who have participated in other clinical trials within 30 days prior to the screening period; (9) The subject is judged by the investigator to have other systemic diseases that are not suitable for participating in this trial; (10) Subjects who are unable to communicate or do not follow the investigator's instructions; (11) Other conditions that the investigator considers inappropriate to participate in this trial. Note: All the above criteria are "no" to be enrolled
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of improvement in Lemperle's wrinkle grade as assessed by the blinded investigator; | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of improvement in Lemperle's wrinkle grade as assessed by the blinded investigator;The assessment of graded improvement rate of GAIS as assessed by the blinded investigator;The assessment of graded improvement rate of GAIS as assessed by the subject;FACE-Q Satisfaction with Skin & FACE-Q Satisfaction with Outcome;Difference between VISIA face image acquisition data and baseline data;Differences in skin water content, oil content, skin elasticity measurements from baseline data;vital signs;VAS Assessment;Adverse event;Device deficiency; | — |
Countries
China
Contacts
Public ContactNanze Yu\Xiaojun Wang
Peking Union Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed