CelluliteNCT02427698
Cyrolipolysis vs Cyrolipolysis and Subcision for Cellulite
A study testing cyrolipolysis (CoolSculpting device) and subcision in people with Cellulite, run by Northwestern University at 1 site in United States.
Trial summary
This is a prospective randomized controlled study comparing the efficacy of cryolipolysis versus a combination of cryolipolysis and surgical subcision for the treatment of cellulite. The treatment sites are both outer thighs. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cellulite
- What is being tested?
- cyrolipolysis (CoolSculpting device) and subcision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy female subjects 18-65 years of age with at least a 5 on the CSS scale on both outer thighs.
- 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.
Who cannot join
- Subjects who are 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 hemoglobulinuria, cold urticaria.
- Subjects who have active skin disease or skin infection in the treatment area.
- Subjects who are allergic to lidocaine or prilocaine.
- Subjects who are allergic to both cephalexin (or penicillin) AND levofloxacin (or another quinolone antibiotic).
- Subjects who have history of abnormal scarring.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, 60611
About this study
Official title: Comparison of the Efficacy Between Cryolipolysis Versus Cryolipolysis Plus Subcision For Treatment of Cellulite: A Prospective Randomized Control Trial
This is a prospective randomized controlled study comparing the efficacy of cryolipolysis versus a combination of cryolipolysis and surgical subcision for the treatment of cellulite. The treatment sites are both outer thighs. One outer thigh will be randomized to receive one treatment of cryolipolysis, while the contralateral thigh will be assigned to receive the combination cryolipolysis plus surgical subcision. A live rating by a blinded dermatologist will evaluate the treatment and control areas using a cellulite severity scale at week 0 (before treatment) and at the 3-month follow up visit.
- Conditions
- Cellulite
- Being tested
- cyrolipolysis (CoolSculpting device), subcision
- Medical subject headings
- Cellulite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyrolipolysis (CoolSculpting device)Procedure or surgery
Treatment will be a cold exposure for up to 120 minutes using the CoolSculpting device with a commercially available treatment setting.
subcisionProcedure or surgery
The skin will be punctured using a subcision needle to cut the septa responsible for the skin depression after cryolipolysis.
| Study group | Role | What they receive |
|---|---|---|
| cyrolipolysis | Active comparator | Not described Receives: Procedure: cyrolipolysis (CoolSculpting device) |
| cryolipolysis plus subcision | Active comparator | Not described Receives: Procedure: cyrolipolysis (CoolSculpting device); Procedure: subcision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live rating by a blinded dermatologist using cellulite severity scale
The cellulite severity scale rates cellulite 1-5 as mild, 6-10 as moderate, and 11-15 as severe.
Measured: Change from Baseline in cellulite severity scale at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startAug 2015
- Primary completion20 May 2026
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CelluliteStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Zeltiq Aesthetics
- Responsible party
- Principal investigator, Murad Alam, Northwestern University
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427698
- Sponsor's protocol ID
- STU200346
- Status last verified
- May 2026
- First submitted
- 13 Apr 2015
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy Between Cryolipolysis Versus Cryolipolysis Plus Subcision For Treatment of Cellulite: A Prospective Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02427698
- Acronym / sponsor ID
- STU200346
- Conditions
- Cellulite
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Zeltiq Aesthetics
- Study start
- Aug 2015
- Primary completion
- 20 May 2026 (actual)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 Apr 2015 (estimated)
- 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 is a prospective randomized controlled study comparing the efficacy of cryolipolysis versus a combination of cryolipolysis and surgical subcision for the treatment of cellulite. The treatment sites are both outer thighs. One outer thigh will be randomized to receive one treatment of cryolipolysis, while the contralateral thigh will be assigned to receive the combination cryolipolysis plus surgical subcision. A live rating by a blinded dermatologist will evaluate the treatment and control areas using a cellulite severity scale at week 0 (before treatment) and at the 3-month follow up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cyrolipolysis | Active comparator | Procedure: cyrolipolysis (CoolSculpting device) |
| cryolipolysis plus subcision | Active comparator | Procedure: cyrolipolysis (CoolSculpting device), Procedure: subcision |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy female subjects 18-65 years of age with at least a 5 on the CSS scale on both outer thighs.
- 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.
Key exclusion criteria (8 listed)
- Subjects who are 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 hemoglobulinuria, cold urticaria.
- Subjects who have active skin disease or skin infection in the treatment area.
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 |
|---|---|---|
| cyrolipolysis (CoolSculpting device)Treatment will be a cold exposure for up to 120 minutes using the CoolSculpting device with a commercially available treatment setting. | Procedure or surgery | cryolipolysis plus subcision, cyrolipolysis |
| subcisionThe skin will be punctured using a subcision needle to cut the septa responsible for the skin depression after cryolipolysis. | Procedure or surgery | cryolipolysis plus subcision |
Primary outcome
Live rating by a blinded dermatologist using cellulite severity scale
Time frame: Change from Baseline in cellulite severity scale at 3 months
The cellulite severity scale rates cellulite 1-5 as mild, 6-10 as moderate, and 11-15 as severe.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
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Thigh Cellulite
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.
Murad Alam, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cyrolipolysis (CoolSculpting device) and subcision in people with Cellulite, run by Northwestern University at 1 site in United States.
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 3 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. 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 States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live rating by a blinded dermatologist using cellulite severity scale (time frame: Change from Baseline in cellulite severity scale at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2026; AzTrials last refreshed its copy on 3 Nov 2026.