An interventional study of Compression pants in Cellulite, sponsored by The Whiteley Clinic. Status unknown at 1 site in United Kingdom. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-12.
Sponsored by The Whiteley Clinic · Not applicable, Interventional, and Treatment
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:
Stage 1:
The first stage of the trial is an induction and stabilisation phase. The participants will be seen on the first visit, the trail explained, and any questions answered. If the participant wishes to proceed, a consent form will be signed and the participant will be measured for the correct size Cell-u-Light product - but the product will NOT be given to the patient until visit 3, to prevent them from trying the product out before the trial stage.
They will then have the assessments performed and recorded. They will be given the time and dates of their next 8 weekly visits.
Visit 2 (end of week one) and visit 3 (end of week 3) will be part of stage 1. The Cell-u-light pants will not be given to the patient until visit 3 to
Stage 2:
The second stage of the trial will begin on the third visit (at the end of week 2) and will last for 4 weeks. Participants will be given the Cell-u-light low-compression apparel to wear and shown the correct method of donning and doffing. They will be instructed to wear them daily for a continuous 8-hour period. Participants can choose which 8 hours suits them best.
Participants will be instructed to remove the apparel a minimum of 2 hours before attending their appointments. This will allow time for small indentations left on the skin surface (caused by the ink-polymer pads) to dissipate, so that imaging and subjective assessments are accurate.
Stage 3:
The final stage will act as a 2 week 'wash-out' period. Participants will stop wearing the Cell-u-light and will have two final appointments at the clinic to record and observe any residual effects of the prior intervention.
Throughout the duration of the study, it will be vital that participants maintain their usual diet and exercise levels to avoid any fluctuations in weight (that may in turn affect the appearance of their cellulite). In this way, the investigators can ensure that any difference is due solely to the effects of Cell-u-Light. To further reduce deviations in weight, lymph abundance, etc. visits to the clinic will be standardised for each volunteer such that each appointment will be at the same time each week.
The trial will be performed in the clinical area in (the CQC registered) Whiteley Clinic. The temperature will be controlled and monitored to be within 20-22 centigrade. Consent for the trial and further usage of images in future publications will be obtained from all participants. [It will not be possible to ascertain which volunteer is being described from any photography.]
Participants will undergo non-invasive measurements, medical photographic imaging and scans to assess the following:
For the subjective grading of each participants' cellulite, the investigators will use the grading system described by Nunberger \& Muller. This consists of 4 grades (0, 1, 2 and 3) as seen below, however, only 3 will be used as Grade 0 is the classification for 'no cellulite present' and therefore, does not fit the purpose of our study.
Exclusion Criteria:
All participants
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
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
Time frame: 9 weeks
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
Allows for statistical analysis between scores to see if there is a significant difference between the two.
Time frame: 9 weeks
Plan to share: No — IPD will not be shared with other researchers
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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