Main Study: A Randomized, Evaluator-blinded, No-treatment Controlled, Multicenter Study to Evaluate the Effectiveness and Safety of GAL1906 for Correction of Wrinkles in the décolletage Area Sub-study: A Follow-up Sub-study to Assess Interpretation of Mammograms Following Treatment for Correction of Wrinkles in the Décolletage Area in the Investigational Study 43USRV1906
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 211
- 试验地点
- 15
- 主要终点
- Main study: The percentage of responders on the Galderma Décolletage Scale, as assessed live by the Blinded Evaluator, at Week 12.
研究概览
简要总结
Main study: Randomized, evaluator-blinded, no treatment controlled multicenter study to evaluate safety and effectiveness of GAL1906 for the correction of wrinkles in the décolletage area.
Sub-study: To evaluate imaging interpretation of mammograms in subjects who were enrolled and treated in the 43USRV1906 main study. The sub-study will determine if hyaluronic acid injections in the décolletage interfere with diagnosis or interpretation of mammogram results.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •for Main study:
- •Subjects willing to comply with the requirements of the study and providing a signed written informed consent.
- •Non-pregnant, non-breastfeeding females, over the age of
- •Subjects seeking treatment for the décolletage.
- •Inclusion Criteria for Sub-study:
- •Subject was willing to comply with the requirements of the study and provide a signed written informed consent.
- •Subject had received treatment with GAL1906 in the main protocol.
排除标准
- •for Main study:
- •Known/previous allergy or hypersensitivity to any injectable HA gel or to gram positive bacterial proteins.
- •History of allergy or hypersensitivity to lidocaine or other amidetype anesthetics, or topical anesthetics or nerve blocking agents (if such products are intended to be used for that subject).
- •Exclusion Criteria for Sub-study:
- •Subject was pregnant or nursing AND has no mammogram taken post GAL1906 treatment.
研究组 & 干预措施
Control
No treatment control
GAL1906
Experimental product for correction of wrinkles
干预措施: GAL1906 (Device)
Sub-Study
FDA requested extension for mammographic information, which was collected retrospectively as performed per standard of care (not performed as a study intervention)
结局指标
主要结局
Main study: The percentage of responders on the Galderma Décolletage Scale, as assessed live by the Blinded Evaluator, at Week 12.
时间窗: 12 weeks after initial injection
Responder defined as at least one grade improvement from baseline
Sub-study: Incidence of Breast Image Interference, as Determined by Adjudicated Radiologist
时间窗: Through the study completion, within 3 months of study start (approximately)
Incidence of breast image interference, as determined by adjudicated radiologist, leading to potential misdiagnosis due to interference of GAL1906, by evaluation of all performed and collected diagnostic methods as well as comparison of post-treatment mammograms to pretreatment mammograms per subject if applicable.
次要结局
未报告次要终点