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

NCT01671839 | Completed Results DMC FDA Device

• 1 other identifier: CP-01-1004
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 3

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.

Conditions

Gynoid Lipodystrophy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Improvement in Cellulite Severity Grade

  3 and 5 years

• Improved Appearance

  Treatment to 3 and 5 years

• Subject Satisfaction

  Treatment to 3 and 5 years

• Procedure Tolerability

  Treatment to 3 and 5 years

• Safe Treatment

  Treatment to 3 and 5 years

Study Arms (1)

Subcutaneous tissue release

EXPERIMENTAL

Device: Subcutaneous tissue release with the Cabochon System

Device: Subcutaneous tissue release with the Cabochon System

Interventions

Subcutaneous tissue release with the Cabochon System DEVICE

Device: Subcutaneous tissue release

Also known as: Cellfina®

Subcutaneous tissue release

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merz North America, Inc.: lead
• Ulthera, Inc: collaborator

Study Sites (3)

The Coleman Center for Cosmetic and Dermatologic Surgery

Metairie, Louisiana, 70006, United States

Location

Maryland Laser Skin & Vein Institute

Hunt Valley, Maryland, 21030, United States

Location

SkinCare Physicians

Chestnut Hill, Massachusetts, 02467, United States

Location

Results Point of Contact

• Title: Public Disclosure Manager
• Organization: Merz Pharmaceuticals

clinicaltrials@merz.com

+49 69 1503 0

Study Officials

• Michael S Kaminer

  Skin Care Physicians

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2012
• First Posted: August 24, 2012
• Study Start: August 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2015
• Last Updated: December 10, 2019
• Results First Posted: September 4, 2014

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)