Longitudinal Trial Assessing Cellulite in Women Wearing a New Compression Garment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-04-30

Brief Summary

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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.

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Detailed Description

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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

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Cellulite

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective observational cohort study.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study Cohort

A cohort of 60 biological females who volunteered to be part of the 6 months study.

Group Type EXPERIMENTAL

Compression garment with Vari-pad microdots ink-printed on inside.

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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 = 60.

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.

Sizes:

* Small = 10
* Medium = 20
* Large = 20
* Extra large = 10

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes