A Prospective, Randomized, Multicenter, Self-controlled, Blinded Trial on the Efficacy and Safety of Poly-L-lactic Acid - SCULPTRA - for the Treatment of Corporal Skin Flaccidity.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 7
- 主要终点
- Assess the aesthetic effect through photographs via GAIS score determined by blind evaluator
研究概览
简要总结
This study aims to assess efficacy and safety of Sculptra in the treatment of skin flaccidity in selected areas - arms, anteromedial region, and gluteal regions. To assess the efficacy of Sculptra®, via adapted Global Aesthetic Improvement Scale -GAIS- score determined by blind evaluator, in the treatment of skin flaccidity on the anteromedial region of arm and gluteal region, 4 months after initiating the treatment, based on the assessment of the corporal side randomized to be the first to receive treatment . Considering as an alternative hypothesis of interest a 70% value of the subjects the treated side would have higher GAIS than the untreated side.
详细描述
Ethical and General considerations regarding the study conduction: This study protocol will be reviewed and approved by appropriate IEC/IRB prior to the initiation of the study.
Clinical monitoring: Study conduction will be closely monitored by Galderma representatives, following GCP regulations, applicable standard operating procedures, guides and local regulations.
Data Management: Data may be audited by Galderma Quality Assurance Department and/or CRO prior to or after results of the first statistical analysis on the primary discretion.
Quality assurance, auditing and Inspection: The study will be carried out under the sponsorship of Galderma in accordance with all local and federal regulations, as well as ICH guidelines. Audits and inspections at the research site may be conducted by Galderma representatives or local authorities. All aspects in any study step can be audited by Galderma Quality Assurance / CRO and, as a result, a certificate stating this will be provided.
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
P.S. To assess the efficacy of Sculptra, via adapted Global Aesthetic Improvement Scale score determined by blind evaluator (Outcomes assessor ), in the treatment of skin flaccidity on the anteromedial region of arm and gluteal region, 4 months after initiating the treatment, based on the assessment of the corporal side randomized to be the first to receive treatment. I input as NO MASKING because appears ERROR when I included Outcomes assessor.
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age between 35 and 60 years (including 60 years);
- •Indication for treatment of bilateral skin flaccidity of at least one of two corporal areas candidate for treatment (arms [anteromedial region] or gluteal regions);
- •Mild to moderate flaccidity in the area to be treated, according to investigator's assessment and in accordance with appropriated flaccidity scales for corporal region to be treated;
- •Subjects who understood and signed the Informed Consent Form (ICF) when entering the study, before performing any investigational procedure
排除标准
- •Prior use (<1 year) or planning to use any other aesthetic treatment in the corporal area of interest for study, such as radiofrequency, cryolipolysis;
- •History of liposuction, plastic surgery and / or corrective plastic surgery in the area of the body of interest for the study (arms or gluteal region);
- •History (<1year) of treatment with Sculptra in other corporal area, area without interest for study;
- •History of Sculptra treatment in the area of the body of interest for the study (arms or gluteal region);
- •Any type of comorbidity or clinical condition that, at investigator s discretion, could interfere with study assessments;
- •Using or planning to initiate restrictive diets (at investigator s discretion);
- •Using or planning to initiate use of supplements for weight loss;
- •Diabetes mellitus type 1 or type 2;
- •Autoimmune diseases, collagenosis, decompensated endocrine diseases or any disease that, at investigator's discretion, could interfere with study assessments;
- •Using or have used within 3 months drugs such as corticosteroids, immunosuppressants or others collagen-production inhibitors;
- •Initiated use of hormones or change in dose of hormonal replacement therapy within 3 months;
- •Practices regularly or intend to practice during the study high-performance or impact physical activities, such as weight lifting, marathon, triathlon;
- •Pregnant or breastfeeding, or wishes to get pregnant within the next 18 months, or refuses to use appropriate contraceptive method (in case of women of childbearing potential).
研究组 & 干预措施
Poly-L-Lactic Acid - Sculptra
Each area will be treated with a dose contained in a vial of Sculptra®. For conducting the study, six vials of the product will be available per subject, and one vial will be used in each session with up to maximum a total volume of 16mL per treated area. It will be 3 session with interval of 1 month in total.
干预措施: Poly-L-lactic acid - Sculptra (Device)
结局指标
主要结局
Assess the aesthetic effect through photographs via GAIS score determined by blind evaluator
时间窗: 4 months after starting Side 1 treatment
To see the percentage of research subjects, to which the blind evaluator assigned a Global Aesthetic Improvement Scale score (GAIS) score higher to Side 1 than the corporal side which will be the second to receive treatment (Side 2), 4 months after starting Side 1 treatment.
次要结局
- Assess the frequency with which the blind evaluators identified correctly Side 1, 4 months after initiating treatment on Side 1 through photographs.(4 months after starting Side 1 treatment)
- To assess aesthetic effect of Sculptra on skin flaccidity via GAIS score determined by the investigator(4 months after initiating side 1 treatment)
- Assess the effect of Sculptra on dermal thickness, via high-frequency ultrasound.(4, 6 and 12 months after initiating side 1 treatment as well as 2 and 8 months after initiating Side 2 treatment)
- Incidence, seriousness, severity and relationship of adverse events with the treatment with Sculptra(An average of 1 year)
- Assess efficacy of Sculptra in the treatment of skin flaccidity via GAIS score determined by the investigator.(4, 6 and 12 months after starting side 1 treatment and 6 and 8 months after starting side 2)
- To assess the aesthetic effect of Sculptra in the skin flaccidity treatment, treatment, via GAIS score determined by the research subject.(4, 6 and 12 months after initiating side 1 as well as 6 and 8 months after initiating side 2 treatment)
- Assess the aesthetic effect of Sculptra on skin flaccidity, by comparing S1 to S2 by the research subject.(4 months after initiating side 1 treatment)
- Assess the subject s discomfort with Sculptra application.(1 year)
- Evaluate Sculptra effect on arm circumference, 4, and 12 months after initiating Side 1 treatment(4 and 12 months after initiating side 1 treatment)
- Assess investigator s satisfaction and perception of aesthetic result obtained with Sculptra.(4, 6 and 12 months after initiating side 1 treatment as well as 6 and 8 months after initiating side 2 treatment)
- Assess subject s satisfaction and aesthetic result perception obtained with Sculptra(4, 6 and 12 months after initiating Side 1 treatment, as well as 6 and 8 months after initiating Side2 treatment)
- Evaluate aesthetic effect of Sculptra on skin flaccidity by comparing Side1 to Side2 by the investigator.(4 months after initiating Side 1 treatment)