Gynoid Lipodystrophy
Conditions
Brief 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.
Interventions
DEVICESubcutaneous tissue release with the Cabochon System
Device: Subcutaneous tissue release
Sponsors
Ulthera, Inc
Merz North America, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change (Decrease) in Cellulite Severity | 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
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Cellulite Severity Grade | 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 | 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 | 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 | 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 | Treatment to 3 and 5 years | Freedom from serious adverse events directly attributable to the Cabochon System or procedure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subcutaneous Tissue Release Device: Subcutaneous tissue release with the Cabochon System
Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release | 55 |
| Total | 55 |
Baseline characteristics
| Characteristic | Subcutaneous Tissue Release |
|---|---|
| Age, Continuous | 40.7 Years STANDARD_DEVIATION 9.1 |
| Sex: Female, Male Female | 55 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 37 |
| other Total, other adverse events | 4 / 55 | 0 / 37 |
| serious Total, serious adverse events | 0 / 55 | 0 / 37 |
Outcome results
Primary
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.
Time frame: Treatment to 3 and 5 years
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Subcutaneous Tissue Release | Mean Change (Decrease) in Cellulite Severity | 3 years | 2.0 units on a scale |
| Subcutaneous Tissue Release | Mean Change (Decrease) in Cellulite Severity | 5 years | 1.8 units on a scale |
Secondary
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
Time frame: Treatment to 3 and 5 years
Population: The primary analysis was based upon the complete case population (CC).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous Tissue Release | Improved Appearance | Worse | 0 percentage of subjects |
| Subcutaneous Tissue Release | Improved Appearance | Very Much Improved | 8.9 percentage of subjects |
| Subcutaneous Tissue Release | Improved Appearance | Much Improved | 46.7 percentage of subjects |
| Subcutaneous Tissue Release | Improved Appearance | Improved | 44.4 percentage of subjects |
| Subcutaneous Tissue Release | Improved Appearance | No Change | 0 percentage of subjects |
| Subcutaneous Tissue Release - 5 Years | Improved Appearance | No Change | 0 percentage of subjects |
| Subcutaneous Tissue Release - 5 Years | Improved Appearance | Improved | 64.9 percentage of subjects |
| Subcutaneous Tissue Release - 5 Years | Improved Appearance | Very Much Improved | 5.4 percentage of subjects |
| Subcutaneous Tissue Release - 5 Years | Improved Appearance | Worse | 0 percentage of subjects |
| Subcutaneous Tissue Release - 5 Years | Improved Appearance | Much Improved | 29.7 percentage of subjects |
Secondary
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.
Time frame: 3 and 5 years
Population: 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 endpoint outcomes.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous Tissue Release | Improvement in Cellulite Severity Grade | 5 years | 86 percentage of subjects |
| Subcutaneous Tissue Release | Improvement in Cellulite Severity Grade | 3 years | 91.1 percentage of subjects |
Secondary
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
Time frame: Treatment to 3 and 5 years
Population: The primary analysis was based upon the complete case population (CC).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subcutaneous Tissue Release | Procedure Tolerability | 0 units on scale | Standard Deviation 0 |
| Subcutaneous Tissue Release - 5 Years | Procedure Tolerability | 0 units on scale | Standard Deviation 0 |
Secondary
Safe Treatment
Freedom from serious adverse events directly attributable to the Cabochon System or procedure.
Time frame: Treatment to 3 and 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subcutaneous Tissue Release | Safe Treatment | 0 occurence of serious adverse events |
| Subcutaneous Tissue Release - 5 Years | Safe Treatment | 0 occurence of serious adverse events |
Secondary
Subject Satisfaction
Subject rated satisfaction according to a 5 point Likert scale after treatment: Very Satisfied Satisfied Neutral Unsatisfied Very Unsatisfied
Time frame: Treatment to 3 and 5 years
Population: The primary analysis was based upon the complete case population (CC).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subcutaneous Tissue Release | Subject Satisfaction | % Satisfied | 51.1 percentage of subjects |
| Subcutaneous Tissue Release | Subject Satisfaction | % Unsatisfied | 0 percentage of subjects |
| Subcutaneous Tissue Release | Subject Satisfaction | % Neutral | 6.7 percentage of subjects |
| Subcutaneous Tissue Release | Subject Satisfaction | % Very Unsatisfied | 0 percentage of subjects |
| Subcutaneous Tissue Release | Subject Satisfaction | % Very Satisfied | 42.2 percentage of subjects |
| Subcutaneous Tissue Release - 5 Years | Subject Satisfaction | % Very Unsatisfied | 0 percentage of subjects |
| Subcutaneous Tissue Release - 5 Years | Subject Satisfaction | % Very Satisfied | 46.0 percentage of subjects |
| Subcutaneous Tissue Release - 5 Years | Subject Satisfaction | % Satisfied | 32.4 percentage of subjects |
| Subcutaneous Tissue Release - 5 Years | Subject Satisfaction | % Neutral | 18.9 percentage of subjects |
| Subcutaneous Tissue Release - 5 Years | Subject Satisfaction | % Unsatisfied | 0 percentage of subjects |