CelluliteNCT05748678
Does Cell-U-Light Apparel Improve Cellulite
A study testing Compression pants in people with Cellulite, run by The Whiteley Clinic at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cellulite
- What is being tested?
- Compression pants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Feb 2023to 3 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Those who have had abdominal/leg operations within 1 year
- Those who are not mobile
- Those who are pregnant or planning to get pregnant
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
The Whiteley Clinic
Guildford, GU2 7RF
Mark S Whiteley, MS FRCS (Gen) MBBS, 0330 0581 850, mark@thewhiteleyclinic.co.uk
About this study
Official title: A Study Evaluating the Efficacy of Cell-u-Light Apparel in Enhancing Lymph Drainage and Improving the Appearance of Grades of Cellulite in Affected Participants
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).
Read more
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.
Read the detailed description
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:
- Height - Only needed at the initial visit.
- Weight
- Appearance of cellulite
- Assessment of lymph in the thigh and buttock regions
- Subjective opinion of comfort and ease of donning and doffing of the apparel by participant
- Subjective grading of cellulite by participant
- Objective grading of cellulite by aesthetician
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.
- Conditions
- Cellulite
- Being tested
- Compression pants
- Keywords
- compression, cellulite, appearance
- Medical subject headings
- Cellulite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression pantsDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Use of the compression apparel | Experimental | All participants Receives: Device: Compression pants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Allows for statistical analysis between scores to see if there is a significant difference between the two.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start20 Feb 2023
- Primary completion3 Apr 2023 (estimated)
- Study completion3 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CelluliteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Wearing apparell similar to cycling shorts which compresses the target area of the buttocks and thighs
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Whiteley Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Canfield
- Responsible party
- Principal investigator, Mark Whiteley, The Whiteley Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748678
- Sponsor's protocol ID
- TWC-SM-2022-03
- Status last verified
- Apr 2023
- First submitted
- 25 Jan 2023
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers
Publications
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.
PubMed 37750084
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating the Efficacy of Cell-u-Light Apparel in Enhancing Lymph Drainage and Improving the Appearance of Grades of Cellulite in Affected Participants
- ClinicalTrials.gov ID
- NCT05748678
- Acronym / sponsor ID
- TWC-SM-2022-03
- Conditions
- Cellulite
- Keywords
- compression, cellulite, appearance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The Whiteley ClinicUniversity, hospital or other
- Collaborators
- Canfield
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 3 Apr 2023 (estimated)
- Study completion
- 3 Apr 2023 (estimated)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Height - Only needed at the initial visit.
- Weight
- Appearance of cellulite
- Assessment of lymph in the thigh and buttock regions
- Subjective opinion of comfort and ease of donning and doffing of the apparel by participant
- Subjective grading of cellulite by participant
- Objective grading of cellulite by aesthetician
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Wearing apparell similar to cycling shorts which compresses the target area of the buttocks and thighs
| Arm | Type | Receives |
|---|---|---|
| Use of the compression apparel | Experimental | Device: Compression pantsAll participants |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compression pantsPatients 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 | Device | Use of the compression apparel |
Primary outcome
To calculate the volume of dimpling from the 3D scanner
Time frame: 9 weeks
Use this to objectively determine whether there is a change in appearance of cellulite with compression
1 secondary outcome
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
Time frame: 9 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Derived from this study: PubMed 37750084Kiely 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.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression pants in people with Cellulite, run by The Whiteley Clinic at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark S Whiteley (03300581850, mark@thewhiteleyclinic.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To calculate the volume of dimpling from the 3D scanner (time frame: 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05748678, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.