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

Gynoid Lipodystrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01671839
• Other study ID #: CP-01-1004
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: December 2015

Study information

• Verified date: August 2019
• Source: Merz North America, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 2015
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cellulite
• Gynoid Lipodystrophy
• Lipodystrophy

Intervention

Device:
• Subcutaneous tissue release with the Cabochon System
Device: Subcutaneous tissue release

Locations

Country	Name	City	State
United States	SkinCare Physicians	Chestnut Hill	Massachusetts
United States	Maryland Laser Skin & Vein Institute	Hunt Valley	Maryland
United States	The Coleman Center for Cosmetic and Dermatologic Surgery	Metairie	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Merz North America, Inc.	Ulthera, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Treatment to 3 and 5 years
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.	3 and 5 years
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	Treatment to 3 and 5 years
Secondary	Subject Satisfaction	Subject rated satisfaction according to a 5 point Likert scale after treatment: Very Satisfied Satisfied Neutral Unsatisfied Very Unsatisfied	Treatment to 3 and 5 years
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	Treatment to 3 and 5 years
Secondary	Safe Treatment	Freedom from serious adverse events directly attributable to the Cabochon System or procedure.	Treatment to 3 and 5 years