Does Cell-U-Light Apparel Improve Cellulite

NCT05748678 | Unknown

• 1 other identifier: TWC-SM-2022-03
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is arranged in 3 stages, lasting 8 weeks overall, designed to assess the before, during and after effects of the low-compression apparel with its integrated, variably raised, ink-polymer pads. The study will recruit 21 (otherwise healthy) participants who are affected by cellulite. Volunteers will be selected in order to equally fill the 3 different grades of cellulite (7 volunteers of each grade (1, 2 \& 3) - as Grade 0 is no evidence of cellulite, this category need not be included). Each volunteer will be 'sized' according to standard apparel sizing charts (as used by the manufacturer of the cycle shorts); Small (S), Medium (M), Large (L) and Extra Large (XL). All participants will follow the same 3 stage sequence, which will involve a total of 9 short visits to The Whiteley Clinic, each lasting approximately 30 minutes. Upon completion of these visits, participants will each be offered £90 to subsidise their cost of travel - they will also be permitted to keep the low-compression apparel following the study. During each appointment, several measurements and assessment will be made:

• Standard demographics, weight, height, and any changes to dietary or exercise regimens over the trial period.
• Subjective assessment of the cellulite by the participant.
• Objective assessment and grading using the grading system described by Nunberger and Muller by the investigators
• Images of their cellulite-affected areas will be taken (this may include an area over the buttocks and an area over the thighs), using a high-resolution medical imaging (camera) system (Vectra H2 (https://www.canfieldsci.com/imaging-systems/vectra-h2-3d-imaging-system/)), to be independently assessed by Canfield Consultants and to be graded by a 'panel' of clinicians for objective classifications.
• Assessment of local lymphatic collections in the skin using a handheld lymph scanner to assess lymph accumulation (Delfin Lymphscanner, Delfin Technologies Ltd https://hadhealth.com/lymphscanner).
• During stage 2 only, participant assessment as to ease of donning and doffing the product, and comfort of wearing it.

Conditions

Cellulite

Keywords

compression; cellulite; appearance

Outcome Measures

Primary Outcomes (1)

• To calculate the volume of dimpling from the 3D scanner

  Use this to objectively determine whether there is a change in appearance of cellulite with compression

  9 weeks

Secondary Outcomes (1)

• Using a visual analogue score for the participants and two blinded observers to score the appearance of cellulite from 0 to 10, 0 being the worst, 10 being the best to statistically analyse whether the opinion of cellulite has changed

  9 weeks

Study Arms (1)

Use of the compression apparel

EXPERIMENTAL

All participants

Device: Compression pants

Interventions

Compression pants DEVICE

Patients will have 3D photos taken each week of each buttock and thigh separately. A lymph scanner will also be used for each section to provide a percentage of water content. Weight will also be taken for each visit. The first 2 weeks the patients will wear their regular pants, and from weeks 3-7 wear the compression pants provided. Weeks 8-9 the patients will be asked to resume to regular pants again

Use of the compression apparel

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: This is based on sex not gender.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Affected by stages 1, 2 or 3 of cellulite
• Can be placed into one of the sizes of the apparel (S, M, L, or XL)
• Have had no recent abdominal/leg surgery
• Are physically able to apply and remove low-compression apparel safely

You may not qualify if:

• Those on any special diets/medications that may affect weight especially hormone treatments that are changing such as IVF cycles
• Any malignancy that is being actively investigated or treated
• Any medical condition that is being actively investigated or treated
• Anyone who is on special diets for weight loss or other health issues, with the exception of those on stable diets such a gluten free for coeliac.
• Previous DVT
• (Unusual/abnormal) leg swelling
• Those who have had abdominal/leg operations within 1 year
• Those who are not mobile
• Those who are pregnant or planning to get pregnant

Sponsors & Collaborators

• The Whiteley Clinic: lead
• Canfield: collaborator

Study Sites (1)

The Whiteley Clinic

Guildford, GU2 7RF, United Kingdom

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Cellulite

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Mark S Whiteley

CONTACT

03300581850; mark@thewhiteleyclinic.co.uk

Melissa J Kiely

CONTACT

01483544960; melissa.kiely@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: Consultant Venous Surgeon

Model Details: Wearing apparell similar to cycling shorts which compresses the target area of the buttocks and thighs

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: March 1, 2023
• Study Start: February 20, 2023
• Primary Completion: April 3, 2023
• Study Completion: April 3, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)