An interventional study of cryolipolysis and Subcision in Cellulite, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-03.
Sponsored by Northwestern University · Not applicable, Interventional, and Treatment
This study intended to investigate and compare the changes that may occur in response to cryolipolysis (localized cool exposure) and subcision (surgical technique) on cellulite. The cryolipolysis cooling device used is FDA approved for skin cooling, but still investigational in the treatment of cellulite. It has previously been used for fat reduction on love handles or back fat. During cryolipolysis, the system drew fat tissue into an applicator then exposes the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite. Subcision is a process used to treat scars left behind by acne or other skin diseases and has been noted to improve moderate to severe cellulite. Subcision is a simple surgical procedure that is performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle is moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together. This study was a pilot study designed to determine feasibility of these procedures.
71 studies on the registry are indexed under Cellulite; 3 are open to participants now.
This study's enrollment of 22 is below the median of 34 across 65 interventional studies indexed under Cellulite.
Browse Cellulite studies →Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: cryolipolysis
Procedure: Subcision
Areas with cellulite that had no treatment performed were considered the control arm.
Other: Control
During cryolipolysis, the system drew fat tissue into an applicator then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite
Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle is moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together.
Also known as: No intervention in this group
Blinded Rating of the Treatment Area (Cryolipolysis vs. Subcision) With the Best Cosmetic Appearance.
Two dermatologists blindly evaluated and compared the treated and control areas of each side at the final follow up visit (week 12). They rated the area with the best cosmetic appearance and reported the percentages of participants for whom "Cryolipolysis" or "Subcision" resulted in the "best cosmetic appearance". It was possible for raters to determine that neither treatment outperformed the other, thereby rating the control arm better.
Time frame: 12 weeks
| Milestone | Subjects Receiving Split Body Treatment |
|---|---|
| Started | 22 |
| Completed | 18 |
| Not completed | 4 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Lost to follow-up | 3 |
Two dermatologists blindly evaluated and compared the treated and control areas of each side at the final follow up visit (week 12). They rated the area with the best cosmetic appearance and reported the percentages of participants for whom "Cryolipolysis" or "Subcision" resulted in the "best cosmetic appearance". It was possible for raters to determine that neither treatment outperformed the other, thereby rating the control arm better.
| Percentage of participants | Cryolipolysis | Subcision | Control |
|---|---|---|---|
| Blinded Rating of the Treatment Area (Cryolipolysis vs. Subcision) With the Best Cosmetic Appearance. | 22.22 (6.41 to 47.64) | 33.33 (13.34 to 59.01) | 44.44 (21.53 to 69.24) |
Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cryolipolysis | — | 0/22 (0%) | 0/22 (0%) |
| Subcision | — | 0/22 (0%) | 3/22 (13.6%) |
| Control | — | 0/22 (0%) | 0/22 (0%) |
| Event | Cryolipolysis | Subcision | Control |
|---|---|---|---|
| lumpsGeneral disorders | 0/22 | 2/22 | 0/22 |
| small ulcerGeneral disorders | 0/22 | 1/22 | 0/22 |
| Age, Categorical(Participants) | Subjects Receiving Split Body Treatment |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 22 |
| >=65 years | 0 |
| Age, Continuous(years) | Subjects Receiving Split Body Treatment |
|---|---|
| Mean | 39.4 ± 11.2 |
| Sex: Female, Male(Participants) | Subjects Receiving Split Body Treatment |
|---|---|
| Female | 22 |
| Male | 0 |
| Region of Enrollment(participants) | Subjects Receiving Split Body Treatment |
|---|---|
| United States | 22 |
The record gives a start of Oct 2010, a primary completion of Sep 2011 and a completion of Sep 2011. It does not say whether these dates are actual or estimated.
Results were first posted in Feb 2014, 2 years 5 months after primary completion.
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This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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