Clinical trial NCT05959681: Longitudinal Trial Assessing Cellulite in Women Wearing a New Compression Garment
Official title: Longitudinal Trial Assessing Cellulite in Women Wearing a New Compression Garment - One Side With Ink Printed Micro-pads ("Vari-pads") and One Side Without.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cellulite
Keywords: compression
Lead sponsor: The Whiteley Clinic
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective observational cohort study.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to subjective improvement on side with Vari-pads
timeFrame: 0-6 months
Secondary outcomes:
measure: Quality of life changes
timeFrame: 0-6 months
measure: Objective clinical assessement of photographs by 2 blinded observers
timeFrame: 0-6 months
measure: Transcutaneous water content
timeFrame: 0-6 months
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: The Whiteley Clinic
Study officials:
References:
citation: Arora G, Patil A, Hooshanginezhad Z, Fritz K, Salavastru C, Kassir M, Goldman MP, Gold MH, Adatto M, Grabbe S, Goldust M. Cellulite: Presentation and management. J Cosmet Dermatol. 2022 Apr;21(4):1393-1401. doi: 10.1111/jocd.14815. Epub 2022 Feb 14.
citation: Kiely MJ, Poulsen A, Muschamp SD, Sallis C, Whiteley MS. Participant Reported Improvement in Cellulite by Vari-Pad Apparel and Objective Measurements - A "First Use" Pilot Study. Clin Cosmet Investig Dermatol. 2023 Sep 20;16:2573-2583. doi: 10.2147/CCID.S426978. eCollection 2023.
citation: Nurnberger F, Muller G. So-called cellulite: an invented disease. J Dermatol Surg Oncol. 1978 Mar;4(3):221-9. doi: 10.1111/j.1524-4725.1978.tb00416.x.
citation: Hexsel D, Weber MB, Taborda ML, Dal'Forno T, do Prado DZ. Celluqol® - a quality of life measurement for patients with cellulite. Surgical and Cosmetic Dermatology 2011 (Jan);3(2):96-101