Prospective, Multicentre, Randomized, Blind, Parallel-controlled Clinical Trial Evaluating the Efficacy and Safety of Recombinant Collagen Gel for Correcting Moderate to Severe Nasolabial Wrinkles
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 244
- 试验地点
- 1
- 主要终点
- Effective rate of correcting and improving nasolabial folds 90 days after the last injection
研究概览
简要总结
Trial name: Prospective, multicentre, randomized, blind, parallel-controlled clinical trial to evaluate the efficacy and safety of recombinant collagen gel for correcting moderate to severe nasolabial wrinkles Sponsor: Shaanxi Juzi Biotechnology Co., LTD Objective: To evaluate the efficacy and safety of recombinant collagen gel prepared by Shaanxi Juzi Biotechnology Co., LTD Experimental design: A prospective, multicenter, randomized, blind, parallel controlled experimental design was adopted, and the comparison type was non-inferiority test Sample size: 244 cases Experimental group: control group =1:1 Scope of application: It is suitable for injection into facial dermis or subcutaneous tissue to correct moderate and severe nasolabial wrinkles Case selection: Inclusion criteria (1) Age 18-65 years old (including the threshold value), male and female; (2) Those who have a need to improve nasolabial wrinkles and are rated moderate or severe (corresponding to a score of 3 or 4) on the bilateral nasolabial Wrinkles Severity Rating Scale (as assessed by blind investigators); (3) Voluntarily participate in this clinical trial and sign the subject informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range of 18-65 years old (including threshold), regardless of gender;
- •There is a need to improve nasolabial folds, and the bilateral nasolabial folds severity rating scale (WSRS) is rated as moderate or severe (corresponding to a score of 3 or 4) by blinded researchers;
- •Voluntarily participate in this clinical trial and sign the informed consent form for the subjects.
排除标准
- •Patients with acute or advanced skin diseases (vitiligo, psoriasis, eczema, etc.), obvious scars, active inflammation, infections (bacterial, fungal, viral), cancerous or precancerous lesions, or unhealed wounds in the nasolabial groove area;
- •Those who have received permanent or semi permanent dermal filler treatment (such as hydroxyapatite calcium, polymethyl methacrylate, organosilicon, expanded polytetrafluoroethylene, etc.) at the folds of the nasolabial groove, or plan to receive filler treatment during the study period;
- •Screening for individuals who have undergone facial plastic surgery or other cosmetic procedures at the intended injection site or lower middle part of the nasolabial fold in the previous 6 months, which may affect the WSRS rating (such as facial lifting surgery, botulinum toxin injection, etc.); Or those who plan to undergo any other facial surgery, medication, or laser treatment during the study period;
- •Individuals who have received temporary filler injections such as cross-linked hyaluronic acid, collagen, or polylactic acid in the nasolabial groove area within the previous 12 months, or who have received non cross-linked sodium hyaluronate injections in the nasolabial groove area within the previous 6 months;
- •Scar lumps, scar constitution, and individuals in the active phase of infectious diseases;
- •Those who have bleeding tendency and used anticoagulants within 2 weeks (heparin, warfarin, sodium citrate, aspirin, etc.), uncontrolled diabetes (HbA1c ≥ 7.5%), malignant tumors and other serious systemic diseases, or autoimmune diseases, such as rheumatism, lupus erythematosus, or immune dysfunction;
- •Patients with platelet count below 50 × 109/L or abnormal coagulation mechanism (such as APTT ≥ 1.5 times the upper limit of normal) during the screening period;
- •Abnormal liver and kidney function during the screening period (AST, ALT>1.5 times the upper limit of normal values or Cr>1.5 times the upper limit of normal values);
- •Individuals who have a history of allergies or allergies to local anesthetics such as pig derived materials or collagen materials, potassium dihydrogen phosphate, disodium hydrogen phosphate, or lidocaine (allergic to one or more substances);
- •Visual impairment that affects the subject's self-evaluation;
- •Individuals with a history of psychological disorders and mental illnesses who are unable to cooperate during the trial period;
- •Pregnant or lactating women, and those planning to conceive during the trial period;
- •Individuals who have participated in clinical trials of other intervention devices or within 5 half lives of their last medication in a drug clinical trial within one month prior to the start of this trial;
- •Researchers believe that participants should not participate in this clinical trial.
研究组 & 干预措施
Recombinant collagen coagulation glue
The recombinant collagen gel produced by Shaanxi Juzi Biotechnology Co., Ltd. was used for 1-2 injections.
干预措施: Recombinant collagen gel (Device)
collagen implant agent
Treated with 1-2 injections of collagen implants for the treatment of nasolabial folds manufactured by Shuangmei Biotechnology Co., Ltd.
干预措施: collagen implant agent (Device)
结局指标
主要结局
Effective rate of correcting and improving nasolabial folds 90 days after the last injection
时间窗: 90 days ± 7 days after the last injection
Evaluation method: Blind researchers trained in the Wrinkle Severity Rating Scale (WSRS) were used to grade the injection site photos of subjects before and after injection. Evaluation criteria: Compared with the screening period, if the severity score of bilateral nasolabial folds is reduced by at least one level 90 days after the last injection, it is considered effective improvement. Otherwise, it is considered ineffective improvement.
次要结局
未报告次要终点