Gynoid LipodystrophyNCT01671839

Study of the Cabochon System for Improvement in the Appearance of Cellulite

A study testing Subcutaneous tissue release with the Cabochon System in people with Gynoid Lipodystrophy, run by Merz North America, Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the safety and effectiveness of the Cabochon System for the improvement in the appearance of cellulite. Read more about this study

Who is it for?: Ages 18 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for: Gynoid Lipodystrophy
What is being tested?: Subcutaneous tissue release with the Cabochon System
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 3 sitesUnited States
Study dates: Aug 2012to Dec 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 55 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Female, age 18-55
moderate or severe cellulite
BMI less than 35
will not to try any other cellulite treatments through 12M follow-up
Subject was enrolled and treated in the CP-01-1004 study - Pivotal Study of the Cabochon System for Improvement in the Appearance of Cellulite
Subject understands and accepts the obligation not to try or receive any other cellulite treatments through 3 year follow-up

Who cannot join

cellulite treatment on the thighs or buttocks in the last 90 days
prior liposuction in the thighs or buttocks
Greater than 10% increase or decrease in body weight within past 6 months
evidence of active infection or a fever >38C
current or recent smoker
history of hypertension, diabetes or hypoglycemia

Show all 18Show fewer

history of coagulopathy(ies) and/or on anticoagulant medication
history of cardiopathy or pneumopathy
history of severe anemia
has atrophic scars, or has a history of atrophic scars or keloids
taken within 14 days of treatment:
NSAIDs (e.g. aspirin, ibuprofen, naproxen)
Vitamin E, dietary supplements (e.g. Gingko Biloba, willow bark)
Herbal Teas
Subject is pregnant or lactating
For Extended Follow-Up the following apply:
Subject has undergone an injected drug, energy-based device, minimally-invasive or invasive procedure for contouring or cellulite on the buttocks or thighs since their 12 month study follow-up visit.
Subject has used skin care products (e.g. creams) for improvement in cellulite within 1 month prior to the follow-up visit.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

SkinCare Physicians
Chestnut Hill, Massachusetts, 02467
Maryland Laser Skin & Vein Institute
Hunt Valley, Maryland, 21030
The Coleman Center for Cosmetic and Dermatologic Surgery
Metairie, Louisiana, 70006

Other trials in United States

About this study

Official title: Pivotal Study of the Cabochon System for Improvement in the Appearance of Cellulite

The purpose of this study is to evaluate the safety and effectiveness of the Cabochon System for the improvement in the appearance of cellulite.

Conditions: Gynoid Lipodystrophy
Being tested: Subcutaneous tissue release with the Cabochon System

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Subcutaneous tissue release with the Cabochon SystemDevice
Also called Cellfina®
Device: Subcutaneous tissue release

Study groups in NCT01671839
Study group	Role	What they receive
Subcutaneous tissue release	Experimental	Device: Subcutaneous tissue release with the Cabochon System Receives: Device: Subcutaneous tissue release with the Cabochon System

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change (Decrease) in Cellulite Severity
Achievement of ≥1 point mean reduction in the 0-5 point Cellulite Severity Scale as determined by independent physician assessment of subject photographs taken before and 3 and 5 years after treatment. Cellulite severity was graded on a 0 (no cellulite) to 5 (severe cellulite) for each subject photograph taken at baseline (before treatment) and 3 and 5 years after treatment by an independent and blinded physician panel. The primary endpoint was achievement of a mean post-treatment severity at 3 and 5 years for the study population which was a minimum of 1 point lower than the baseline severity.
Measured: Treatment to 3 and 5 years

Secondary outcomes (5)

Improvement in Cellulite Severity Grade
Percentage of subjects which were scored to have improvement of one grade or more in a 4 point Severity Grade (none, mild, moderate, severe) as determined by independent blinded physician assessment of subject photographs taken before and 3 and 5 years after treatment.
Measured: 3 and 5 years
Improved Appearance
Improvement in subject's cellulite appearance according to a Global Aesthetic Improvement Scale (GAIS) evaluated by independent and blinded physician panel assessment of subject photographs taken before and 3 and 5 years after treatment. Change in the cellulite severity was rated according to 5 measures:
- Very much improved: Optimal cosmetic result in the treated areas for this subject
- Much improved: Marked or significant improvement in appearance of the treated areas from the initial condition
- Improved: Noticeable improvement in appearance of the treated areas from the initial condition but more subtle in magnitude
- No Change: The appearance of the treated areas is essentially the same as the original condition
- Worse: The appearance of the treated areas is worse than the original condition
Measured: Treatment to 3 and 5 years
Subject Satisfaction
Subject rated satisfaction according to a 5 point Likert scale after treatment:
Very Satisfied Satisfied Neutral Unsatisfied Very Unsatisfied
Measured: Treatment to 3 and 5 years
Procedure Tolerability
Subject rated pain according to a 0-10 numerical rating scale. Pain scale ranges from 0 (no pain) to 10 (worst possible pain). Measure was reported as mean and standard deviation of the pain score
Measured: Treatment to 3 and 5 years
Safe Treatment
Freedom from serious adverse events directly attributable to the Cabochon System or procedure.
Measured: Treatment to 3 and 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2012Dec 2015

First posted24 Aug 2012 (estimated)
Study startAug 2012
Primary completionSep 2013
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Gynoid LipodystrophyStudies 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
Masking: None (open label)
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01671839
Sponsor's protocol ID: CP-01-1004
Status last verified: Aug 2019
First submitted: 17 Aug 2012
Last updated: 10 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pivotal Study of the Cabochon System for Improvement in the Appearance of Cellulite
ClinicalTrials.gov ID: NCT01671839
Acronym / sponsor ID: CP-01-1004
Conditions: Gynoid Lipodystrophy
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: Merz North America, Inc.Industry (pharma, biotech, devices)
Collaborators: Ulthera, Inc
Study start: Aug 2012
Primary completion: Sep 2013 (actual)
Study completion: Dec 2015 (actual)
First posted: 24 Aug 2012 (estimated)
Results: Posted 4 Sep 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the safety and effectiveness of the Cabochon System for the improvement in the appearance of cellulite.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Subcutaneous tissue release	Experimental	Device: Subcutaneous tissue release with the Cabochon SystemDevice: Subcutaneous tissue release with the Cabochon System

Who may qualify

Ages: 18 to 55 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Female, age 18-55
moderate or severe cellulite
BMI less than 35
will not to try any other cellulite treatments through 12M follow-up
Subject was enrolled and treated in the CP-01-1004 study - Pivotal Study of the Cabochon System for Improvement in the Appearance of Cellulite

Key exclusion criteria (18 listed)

cellulite treatment on the thighs or buttocks in the last 90 days
prior liposuction in the thighs or buttocks
Greater than 10% increase or decrease in body weight within past 6 months
evidence of active infection or a fever >38C
current or recent smoker

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
Subcutaneous tissue release with the Cabochon SystemAlso: Cellfina®Device: Subcutaneous tissue release	Device	Subcutaneous tissue release

Primary outcome

Mean Change (Decrease) in Cellulite Severity
Time frame: Treatment to 3 and 5 years
Achievement of ≥1 point mean reduction in the 0-5 point Cellulite Severity Scale as determined by independent physician assessment of subject photographs taken before and 3 and 5 years after treatment. Cellulite severity was graded on a 0 (no cellulite) to 5 (severe cellulite) for each subject photograph taken at baseline (before treatment) and 3 and 5 years after treatment by an independent and blinded physician panel. The primary endpoint was achievement of a mean post-treatment severity at 3 and 5 years for the study population which was a minimum of 1 point lower than the baseline severity.

5 secondary outcomes

Improvement in Cellulite Severity Grade
Time frame: 3 and 5 years
Improved Appearance
Time frame: Treatment to 3 and 5 years
Subject Satisfaction
Time frame: Treatment to 3 and 5 years
Procedure Tolerability
Time frame: Treatment to 3 and 5 years
Safe Treatment
Time frame: Treatment to 3 and 5 years

Results and safety

Results posted to the registry on 4 Sep 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Subcutaneous Tissue Release	55	37

Primary outcome: Mean Change (Decrease) in Cellulite Severity

Time frame: Treatment to 3 and 5 years. Mean (95% Confidence Interval). Unit: units on a scale

Measure	Subcutaneous Tissue Release n = 45
3 years	2.0 (1.7 to 2.3)
5 years	1.8 (1.4 to 2.2)

Population analysed: The primary analysis was based upon the complete case population (CC). A supportive analysis was generated on the per-protocol (PP). Best-case, worst-case and multiple imputation techniques were utilized to impute missing primary and powered secondary endpoint outcomes.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline up to year 5.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subcutaneous Tissue Release - 3 Years	0 of 55 (0%)	4 of 55 (7.3%)	0 of 55
Subcutaneous Tissue Release - Years 4-5	0 of 37 (0%)	0 of 37 (0%)	0 of 37

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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.

Michael S Kaminer principal investigator

Skin Care Physicians

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Subcutaneous tissue release with the Cabochon System in people with Gynoid Lipodystrophy, run by Merz North America, Inc. at 3 sites 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 6 inclusion and 18 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: finished, as of the sponsor's last update on 10 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Yes. Results are posted in the registry (first posted 4 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Change (Decrease) in Cellulite Severity (time frame: Treatment to 3 and 5 years). 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 NCT01671839.

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 10 Dec 2019.