Longitudinal Trial Assessing Cellulite in Women Wearing a New Compression Garment

NCT05959681 | Unknown

• 1 other identifier: TWC-SM-2023-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cellulite

Keywords

compression

Outcome Measures

Primary Outcomes (1)

• Time to subjective improvement on side with Vari-pads

  Time to notice difference in cellulite between the sides when wearing garment with one side having Vari-pads.

  0-6 months

Secondary Outcomes (3)

• 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

Study Arms (1)

Study Cohort

EXPERIMENTAL

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

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

Interventions

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

Study Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Whiteley Clinic: lead

Study Sites (1)

The Whiteley Clinic

Guildford, GU2 7RF, United Kingdom

RECRUITING

Related Publications (4)

• 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.

  PMID: 35104044 BACKGROUND

• 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.

  PMID: 37750084 BACKGROUND

• 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.

  PMID: 632386 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Cellulite

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mark S Whiteley, MS FRCS MBBS

CONTACT

03300581850; mark@thewhiteleyclinic.co.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director of The Whiteley Clinic

Model Details: Prospective observational cohort study.

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 25, 2023
• Study Start: August 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)