Study of the Cabochon System for Improv… | Clinical Trial

Key information

Conditions

Gynoid Lipodystrophy

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Coleman Center for Cosmetic and Dermatologic Surgery, Metairie, Louisiana, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Female, age 18-55
moderate or severe cellulite
BMI less than 35
will not to try any other cellulite treatments through 12M follow-up

Exclusion criteria

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
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:

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

Subcutaneous tissue release with the Cabochon System

Device

Device: Subcutaneous tissue release

Other names: Cellfina®

Primary outcomes

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.

Secondary outcomes

Improvement in Cellulite Severity Grade

Time frame: 3 and 5 years

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.
Improved Appearance

Time frame: Treatment to 3 and 5 years
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
Subject Satisfaction

Time frame: Treatment to 3 and 5 years

Subject rated satisfaction according to a 5 point Likert scale after treatment:

Very Satisfied Satisfied Neutral Unsatisfied Very Unsatisfied
Procedure Tolerability

Time frame: Treatment to 3 and 5 years

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
Safe Treatment

Time frame: Treatment to 3 and 5 years

Freedom from serious adverse events directly attributable to the Cabochon System or procedure.

Sponsors and collaborators

Lead sponsor

Merz North America, Inc.

Industry

Collaborators

Ulthera, Inc

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2015
First posted: Aug 24, 2012
Registry last updated: Dec 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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