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Does Cell-U-Light Apparel Improve Cellulite

NCT05748678 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-04-12

No results posted yet for this study

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

Interventions

DEVICE

Compression pants

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

Sponsors & Collaborators

  • Canfield

    collaborator UNKNOWN

  • The Whiteley Clinic

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-20
Primary Completion
2023-04-03
Completion
2023-04-03

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05748678 on ClinicalTrials.gov