NCT05959681

Longitudinal Trial Assessing Cellulite in Women Wearing a New Compression Garment

Longitudinal Trial Assessing Cellulite in Women Wearing a New Compression Garment - One Side With Ink Printed Micro-pads ("Vari-pads") and One Side Without.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The Whiteley Clinic · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Cellulite

Interventions

Type	Name	Description
DEVICE	Compression garment with Vari-pad microdots ink-printed on inside.	Initially, participants wear a garment with Vari-pads on one side (left or right) only and swap to a garment with Vari-pads on both sides if / when the participants notice a difference between the sides. Wearing garment 8 hours per 24 hours.

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-04-01
• Completion: 2024-04-01
• First posted: 2023-07-25
• Last updated: 2023-07-25

Locations

1 site across 1 country: United Kingdom