EUCTR2011-005026-21-DE进行中（未招募）1 期
ong-term, follow-up study of subjects who completed phase III trials ATX-101-10-16 or ATX-101-10-17 (sodium deoxycholate injection) for the reduction of localized subcutaneous fat in the submental area - Long-term follow-up study of ATX-101 for reduction of localized submental fat
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 201
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Signed written informed consent before any study-related activities are carried out
- •- Any subject who successfully completed the final visit (Visit 7) of a phase III clinical trial, ATX-101-16 or ATX-101-17 for the reduction of submental fat, i.e. subjects must have at least one study treatment administered and have completed the predecessor study up to Visit 7
- •- Willingness to comply with the schedule and procedures of the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects who, since the completion of the prior phase III study ATX-101-10-16 or ATX-101-10-17, have had or who are undergoing treatment that may affect the evaluation of the submental area (e.g. - but not limited to - long term treatment with systemic corticosteroids, liposuction, surgery or other lipolytic treatment in the submental area, treatment with radio frequency, laser procedures, chemical peels, dermal fillers in the neck or chin area or botulinum toxin injections in the neck or chin area).
研究者
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