[Trial of device that is not approved or cleared by the U.S. FDA]
试验速览
- 阶段
- 不适用
- 状态
- Withheld
- 发起方
- [Redacted]
- 入组人数
- 125
- 试验地点
- 11
- 主要终点
- Percentage of Responders Having At Least "Improved" in Both Buttocks at Maximal Contraction According to the Global Aesthetic Improvement Scale (GAIS), as Assessed Live by Blinded Evaluator, at Month 9
研究概览
简要总结
The main purpose of the study is to investigate the safety and effectiveness of Sculptra 011611 for improvement in appearance of gluteal skin irregularities.
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)
盲法说明
Evaluator blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participant with moderate to severe skin laxity in the buttocks when standing with the buttocks in repose as evaluated using the Buttocks' Skin Laxity Visual Scale (SLVS) by the Blinded Evaluator and Treating Investigator at the Baseline visit.
- •Women 18 years of age and older.
- •Has intent to undergo treatment to improve skin quality and skin irregularities in the buttock area.
排除标准
- •Previous surgery in or near the treatment area.
- •Previous treatment/procedure in or near the treatment area OR is planning to undergo any procedures affecting the treatment area, at any time during the study.
- •Presence of any disease or lesions near or on the area to be treated.
- •Evidence of scar-related disease or delayed healing activity within 1 year prior to the Baseline visit, or participants susceptible to keloid formation, hyperpigmentation or hypertrophic scarring from injectable procedures.
- •Skin coloring/bleaching/tattoo/stretch marks in the treatment area, which, in the Treating Investigator's opinion, would interfere with the study injections and/or study assessment.
- •An underlying known disease, a surgical or medical condition that would expose the participant to undue risk.
- •Treatment with chemotherapy, immunosuppressive agents, topical and systemic prescription retinoids, topical and systemic corticosteroids within 3 months before treatment.
研究组 & 干预措施
Control Group
Participants will be randomized to not receive any intervention.
Treatment Group
Participants will receive three subcutaneous injection of single regimen of Sculptra 011611. A single regimen consists of up to three injection sessions spaced 1 month (+2 weeks) apart at Baseline, Month 1 and Month 2.
干预措施: Sculptra 016011 (Device)
结局指标
主要结局
Percentage of Responders Having At Least "Improved" in Both Buttocks at Maximal Contraction According to the Global Aesthetic Improvement Scale (GAIS), as Assessed Live by Blinded Evaluator, at Month 9
时间窗: At Month 9
Responder will be defined as participants achieving 'very much improved', 'much improved' or "Improved" on GAIS compared to baseline. The 7-graded GAIS will be used to assess the aesthetic improvement of gluteal skin irregularities by the Blinded Evaluator at maximal contraction by responding to the question: "How would you describe the aesthetic improvement today compared to the photograph taken at Baseline?" for each buttock separately by using the respective categorical scale as follows; Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse. In this outcome measure, percentage of participants who will achieve at least 'Improved' on the GAIS assessed by Blinded Evaluator at Month 9 will be reported.
Percentage of Responders Having At Least "Improved" in Both Buttocks at Maximal Contraction According to the Global Aesthetic Improvement Scale (GAIS), as Assessed Live by Blinded Evaluator, at Month 9
时间窗: At Month 9
Responder will be defined as participants achieving 'very much improved', 'much improved' or "Improved" on GAIS compared to baseline. The 7-graded GAIS will be used to assess the aesthetic improvement of gluteal skin irregularities by the Blinded Evaluator at maximal contraction by responding to the question: "How would you describe the aesthetic improvement today compared to the photograph taken at Baseline?" for each buttock separately by using the respective categorical scale as follows; Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse. In this outcome measure, percentage of participants who will achieve at least 'Improved' on the GAIS assessed by Blinded Evaluator at Month 9 will be reported.
次要结局
- Percentage of Responders Having At Least "Improved" in Appearance of Gluteal Skin Irregularities in Both Buttocks at Maximal Contraction According to GAIS, as Assessed Live by Blinded Evaluator, at Month 3, 6 and 12(At Months 3, 6 and 12)
- Percentage of Responders Having at Least "Improved" in Appearance of Gluteal Skin Irregularities in Both Buttocks in Relaxed State According to GAIS, as Assessed Live by Blinded Evaluator, at Month 3, 6, 9 and 12(At Months 3, 6, 9 and 12)
- Percentage of Responders Having At Least "Improved" in Appearance of Gluteal Skin Irregularities in Both Buttocks at Maximal Contraction According to GAIS, as Assessed Live by Blinded Evaluator, at Month 3, 6 and 12(At Months 3, 6 and 12)
- Percentage of Responders Having at Least "Improved" in Appearance of Gluteal Skin Irregularities in Both Buttocks in Relaxed State According to GAIS, as Assessed Live by Blinded Evaluator, at Month 3, 6, 9 and 12(At Months 3, 6, 9 and 12)