Longitudinal Trial Assessing Cellulite in Women Wearing a New Compression Garment - One Side With Ink Printed Micro-pads ("Vari-pads") and One Side Without.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Time to subjective improvement on side with Vari-pads
研究概览
简要总结
The investigators are investigating a compression garment that appears to reduce the appearance of Cellulite. The garment has both compression and patented ink-printed micro-dots ("Vari-pads"). These Vari-pads on the inner aspect of the garment are thought to increase the lymphatic return over compression alone.
In this study, volunteers with cellulite are asked to wear the garment, with only one side (left or right) having the active Vari-pads. The participants wear the garment for at least 8 hours per day. If, and when, the participants notice a difference between the sides (left and right sides), the participants will notify the investigators. At this point the participants will be invited to the trial centre for an assessment and to be swapped to a garment with Vari-pads on both sides.
Apart from this variable end-point, the participants will be reviewed routinely at 3 and 6 months. The trial ends at 6 months.
详细描述
The product being tested is to be a retail (non-medical) garment. This garment is a pair of standard compression shorts with a pattern of small, raised pads ("Vari-pads") of different heights printed on the inner aspect. A previous trial has suggested that wearing this garment for over eight hours a day can reduce the appearance of cellulite. In addition, participants found these compression pants to be very comfortable.
In this proposed trial, the investigators wish to investigate whether the previously found subjective and objective improvement of the appearance of cellulite is due to the compression alone, or whether the Vari-pads on the inside of the product enhance the subjective or objective impression of cellulite. As such, the investigators have asked the manufacturer to produce 60 pairs of pants where the Vari-pads are printed onto the inner aspects as per usual on one side, but not on the other side. On this other side, there will be a dot of the same colour printed, but it will not be raised.
The participants will be asked to wear the apparel for eight hours or more a day, at times that the participants find most suitable.
If and when the participants notice a difference in the appearance of cellulite between the right and left side, the participants will notify the investigators. At this point the investigators will invite the participants to the trial centre for an assessment. The participants will be swapped into the normal garments which have Vari-pads on both sides. The participants will then wear these garments for the remainder of the trial.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Biological females, over the age of 18 years old, who are able to walk normally and who have cellulite on their buttocks and/or upper thighs.
- •Due to having to produce special garments for this trial where only half of the garment has the Vari-pads, there will be for following restrictions:
- •Total number =
- •Volunteers will be asked their sizes (Small, Medium, Large and Extra large) and will only be invited to attend if there are available places in that category.
- •Small = 10
- •Medium = 20
- •Large = 20
- •Extra large = 10
排除标准
- •Women under 18 years of age.
- •Women who are pregnant or who intend to get pregnant in the next 6 months.
- •Women with no discernible cellulite on initial examination.
- •Women undergoing any other treatment which aims to reduce the appearance of cellulite.
- •Women who are unable to complete at least 3 months of this trial.
结局指标
主要结局
Time to subjective improvement on side with Vari-pads
时间窗: 0-6 months
Time to notice difference in cellulite between the sides when wearing garment with one side having Vari-pads.
次要结局
- Quality of life changes(0-6 months)
- Objective clinical assessement of photographs by 2 blinded observers(0-6 months)
- Transcutaneous water content(0-6 months)
研究者
Mark Whiteley
Medical Director of The Whiteley Clinic
The Whiteley Clinic