Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Stabilized Hyaluronic Acid of Non-animal Origin (Macrolane); a Baseline-controlled Single-centre Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change From 6 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting
研究概览
简要总结
The study is being undertaken to establish the effectiveness and safety of Macrolane volume restoration factor 30 (VRF30) when used for treatment of HIV-infected subjects with buttocks lipoatrophy.
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
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have buttocks lipoatrophy and is unable to remain seated for more than 30 minutes due to pain.
- •Have undergone HIV treatment for more than 2 years.
- •Have RNA copies less than 50/ml.
- •Have CD4 more than 200 cell/mm3.
排除标准
- •Active infections.
- •Active skin disease, inflammation or related conditions.
- •Perineal pathology.
- •Condition that may affect pain assessment.
- •Skin with underlying fibrous tissue.
- •BMI less than
- •Insufficient tissue cover in the area to be treated.
- •Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation within 14 days prior to treatment, or a history of bleeding disorders.
- •Permanent implant placed in the treatment area.
- •Other injectable implant, liposuction or other surgical therapy in the treatment area.
- •Presence or history of connective tissue diseases.
- •Tumors or pre-malign tissue disorder near or on the area to be treated.
- •Contraindications for MRI
- •Previous hypersensitivity to hyaluronic acid, or to the local anesthetic or antibiotic used in the study.
研究组 & 干预措施
Macrolane VRF 30
Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
干预措施: Macrolane VRF 30 (Device)
结局指标
主要结局
Change From 6 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting
时间窗: 6 months after treatment compared to baseline
Pain at sitting was evaluated using a 100 mm VAS with the descriptors 0 = "no pain" to the left and 100 = "worst possible pain" to the right. Pain was assessed by the subject after sitting 15 minutes on a standardized chair. The VAS pain at 6 months was compared to baseline and the change was calculated.
次要结局
- Change From up to 18 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting(Baseline and up to 18 months after treatment)
- Quality of Life Assessed by MOS-HIV (Medical Outcome Study-HIV) Questionnaire(Baseline and at 6 months after treatment)
- Number of Participants With Global Esthetic Improvement(One month and up to 18 months after treatment)
- Number of Participants With Gel Displacement Evaluated by Magnetic Resonance Imaging (MRI)(12 months after treatment)
- Adverse Event Recording(Up to 18 months after treatment)
- Time Until it Became Impossible to Stay Sitting(Baseline and at 6 months after treatment)