NCT06583486已完成3 期
A Multi-center, Open-label Study on the Efficacy and Safety of Repeated Treatments With Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 488
- 试验地点
- 17
- 主要终点
- Incidence of serious adverse events and drug-related adverse events during the study.
研究概览
简要总结
This is a Multi-center, Open-label Study on the Efficacy and Safety of Multiple Treatments with Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines. The study has been designed to evaluate the long-term safety, tolerability, efficacy , maintain time and immunogenicity of multiple treatments with Recombinant Botulinum Toxin Type A for Injection (YY001) in the treatment of moderate to severe glabellar lines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open-label
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
- •Male or female 18 to 65 years (inclusive) at the time of signing the informed consent form.
- •At screening or baseline, participants who complete all visits of the REFINE study without major protocol deviations and SAEs
- •Agree to participate in the study and sign the informed consent form.
- •At the discretion of the investigator, the participants can comply with the protocol requirements.
- •Females and/or males of childbearing potential and their partners: those who should be using effective contraception and have no plans for childbearing, egg donation (females), or sperm donation (males) from the signing of the informed consent form to 3 months after the last administration. female participants of childbearing potential must have had a negative blood pregnancy test (human chorionic gonadotropin) within 7 days prior to the first administration of study drug or a Urine pregnancy test examination must be negative 3 days prior to the first administration of study drug.
- •Women of childbearing potential are those who have experienced menarche, have not undergone sterilization (hysterectomy or bilateral salpingo-oophorectomy or bilateral tubal ligation), and are not in a state of post-menopausal (defined as absence of menstrual bleeding for 12 months prior to screening, without any other medical reason).
- •Effective contraceptives include: vasectomy, abstinence, intrauterine devices, hormones [oral, patch, ring, injections, implants], barrier methods [diaphragm, cervical cap, sponge, condom].
排除标准
- •Use of medications or treatments prohibited by the REFINE study protocol.
- •Any condition that required permanent discontinuation of study treatment during the REFINE study.
- •Use of nonsteroidal anti-inflammatory drugs including aspirin or anticoagulants within 1 week prior to baseline.
- •Abnormal laboratory tests that, in the assessment of the investigator, are not appropriate for participation in this study: including, but not limited to: alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≥ 2.5 times the upper limit of the normal range (×ULN), creatinine ≥ 2 ×ULN, urea/urea nitrogen ≥ 2 ×ULN.
- •Female who is pregnant or breast feeding.
研究组 & 干预措施
Treatment Group
Experimental
Five sites will be repeatedly injected with Rcombinant botulinum neurotoxin type A for injection (YY001) at 0.05 mL each, 2 sites in corrugator muscle of each side and 1 site in the procerus muscle, for a total dose of 20U.The study period is up to 64 weeks, divided into 5 treatment cycles.
干预措施: Rcombinant botulinum neurotoxin type A for injection (YY001) (Biological)
结局指标
主要结局
Incidence of serious adverse events and drug-related adverse events during the study.
时间窗: Up to 64 weeks
次要结局
- The proportion of participants who achieve a score of 0 or 1 on the investigator's assessment of GL severity.(At Weeks 1, 4, 12, 24 (if applicable), and 36 (if applicable) after each treatment.)
- The respond rate on the investigator's assessment of GL severity at maximal frown.(At Weeks 1, 4, 12, 24 (if applicable), and 36 (if applicable) after each treatment.)
- The lasting time from a single injection to the participants' score of GL severity at maximal frown on the investigator's assessment return to the baseline.(Up to 64 weeks)
- The proportion of participants who achieve a score of 0 or 1 on the participant's self-assessment and Independent Review Committee's assessment of GL severity photos at maximal frown taken on-site.(At Weeks 1(for participants), 4, 12, 24 (if applicable), and 36 (if applicable) after each treatment.)
- The proportion of participants with a decrease of at least 1 grade from the baseline, on the investigator's assessment and the participant's self-assessment individually of GL severity at rest.(At Weeks 1, 4, 12, 24 (if applicable), and 36 (if applicable) after each treatment.)
- Incidence of anti-drug antibodies and neutralizing antibodies during the study.(Up to 64 weeks)
研究者
研究点 (17)
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