Cellulite
Conditions
Keywords
Cellulite, Cryolipolysis, Zeltiq, Subcision
Brief summary
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.
Interventions
DEVICEcryolipolysis
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
PROCEDURESubcision
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.
OTHERControl
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy female patients 18-60 years of age with more than one evident depressed lesion of cellulite on the upper thighs and/or buttocks. * All subjects must have the affected areas that show the mattress phenomenon spontaneously when standing or while both lying and standing (Stage 2 or 3 of Nurnberger-Muller grading scale of cellulite7). * Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.
Exclusion criteria
* Pregnant or lactating * Subjects who are unable to understand the protocol or to give informed consent. * Subjects currently under treatment with an antiplatelet or anticoagulant for any medical problem or patients who have coagulation disorder. * Subjects who have a known history of cold-induced disease such as cryoglobulinemia, paroxysmal cold hemoglobinuria, or cold urticaria. * Subjects who have active skin disease or skin infection in treatment area. * Subjects who are allergic to lidocaine or prilocaine. * Subjects who are allergic to both cephalexin (and penicillin) AND levofloxacin (or another quinolone antibiotic). * Subjects who have history of abnormal scarring.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blinded Rating of the Treatment Area (Cryolipolysis vs. Subcision) With the Best Cosmetic Appearance. | 12 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subjects Receiving Split Body Treatment The unit of randomization was the side of the body within each subject to receive either cryolipolysis or subcision.
cryolipolysis : During cryolipolysis, the system drew fat tissue into an applicator and 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 : Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle was 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. | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Subjects Receiving Split Body Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants |
| Age, Continuous | 39.4 years STANDARD_DEVIATION 11.2 |
| Region of Enrollment United States | 22 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 3 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 | 0 / 22 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cryolipolysis | Blinded Rating of the Treatment Area (Cryolipolysis vs. Subcision) With the Best Cosmetic Appearance. | 22.22 Percentage of participants |
| Subcision | Blinded Rating of the Treatment Area (Cryolipolysis vs. Subcision) With the Best Cosmetic Appearance. | 33.33 Percentage of participants |
| Control | Blinded Rating of the Treatment Area (Cryolipolysis vs. Subcision) With the Best Cosmetic Appearance. | 44.44 Percentage of participants |