Feasibility of Producing the Appearance of a Gluteal Lift Post Cryolipolysis

Allergan IIT-2019-10713 Feasibility of Producing the Appearance of a Gluteal Lift Post Cryolipolysis

The purpose of this study is to evaluate the safety and efficacy of cryolipolysis of the medial infragluteal fold to create the appearance of a gluteal lift.

Study Overview

• Status: Unknown
• Conditions: Subcutaneous Fat
• Intervention / Treatment: Device: ZELTIQ thermoelectric device

Detailed Description

In this study, the safety and the efficacy of ZELTIQ's technology will be evaluated for the non-invasive fat reduction of the medial infragluteal folds on a small group of subjects. This is a feasibility study to determine if cryolipolysis in this area produces a desirable lifted appearance to the buttocks. Typically, a lifted more youthful appearance is obtained through surgical means. Study participants will be recruited from the population of patients who have suitable, treatable subcutaneous fat on the medial infragluteal folds and desire a lifted appearance. Subjects will receive treatments with a cooled cup cryolipolysis applicator from the CoolAdvantage family of applicators (cooled cup vacuum applicator). Treatments will be performed with a treatment temperature of - 11°C for up to 35 minutes. Subjects will complete all study-required follow-up visits, including an 8-week follow-up which may include a second treatment session, as well as a 12-week post final treatment follow-up visit.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33133
      • Riverchase Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female subjects > 22 years of age and < 50 years of age.
• Presence of suitable treatable subcutaneous fat on the medial infragluteal folds, which in the investigator's opinion may benefit from CoolSculpting to potentially create a lifted appearance to the buttocks.
• BMI under 30.
• No weight change exceeding 5% of body weight in the preceding month.
• Agreement to maintain their weight (i.e., within 5%) by not making any major changes in their diet or lifestyle during the course of the study.
• Subject has read and signed a written informed consent form

Exclusion Criteria:

• Subject has skin laxity in the area of intended treatment which in the opinion of the investigator, may result in an unacceptable aesthetic result.
• Subject has had a surgical procedure(s) in the area of intended treatment.
• History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.), in or around the area of intended treatment.
• Known history of cryoglobulinemia, cold urticaria, cold agglutinin disease or paroxysmal cold hemoglobinuria.
• Known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
• History of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
• Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
• Currently taking or has taken diet pills or weight control supplements within the past month.
• Any dermatological conditions, such as scars, infection, in the location of the treatment area that may interfere with the treatment or evaluation.
• Active implanted device such as a pacemaker, defibrillator, or drug delivery system.
• Subject has a history of hernia in the areas to be treated.
• Pregnant or intending to become pregnant in the next 5 months.
• Lactating or has been lactating in the past 6 months.
• Unable or unwilling to comply with the study requirements.
• Currently enrolled in a clinical study of any other unapproved investigational drug or device.
• Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Interventional cohort; Zeltiq system is a thermoelectric device that applies controlled cooling ot skin. The CoolAdvantage applicators use gentle vacuum pressure to draw tissue into the cup shaped applicator. A gelpad is applied to skin to improve thermal coupling between participant and the applicator cooling surface.

Device: ZELTIQ thermoelectric device; This is a feasibility study to determine if cryolipolysis in this area produces a desirable lifted appearance to the buttocks. Typically, a lifted more youthful appearance is obtained through surgical means. Study participants will be recruited from the population of patients who have suitable, treatable subcutaneous fat on the medial infragluteal folds and desire a lifted appearance. Subjects will receive treatments with a cooled cup cryolipolysis applicator from the CoolAdvantage family of applicators (cooled cup vacuum applicator). Treatments will be performed with a treatment temperature of - 11°C for up to 35 minutes. Subjects will complete all study-required follow-up visits, including an 8-week follow-up which may include a second treatment session, as well as a 12-week post final treatment follow-up visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-emergent Adverse Events [Safety and Tolerability]	The primary endpoint of the study is to evaluate the safety of subcutaneous fat reduction in the medial intragluteal folds using the ZELTIQ System as a non-invasive clinical treatment. Safety will be measured through the incidence of device and/or procedure-related adverse event.	12 weeks
Subjective clinical evaluation of subcutaneous fat treatment by Cryolipolysis [Efficacy]	The primary endpoint of the study is to evaluate the efficacy of subcutaneous fat reduction in the medial intragluteal folds using the ZELTIQ System as a non-invasive clinical treatment. This will be evaluated by two blinded independent reviewers through the review of pre-treatment vs. post-treatment photos taken with a VECTRA H2 (Canfield Scientific, Inc) camera.	12 weeks
Aggregated measurements of subcutaneous fat treatment by Cryolipolysis [Efficacy]	The primary endpoint of the study is to evaluate the efficacy of subcutaneous fat reduction in the medial intragluteal folds using the ZELTIQ System as a non-invasive clinical treatment. Quantitative measurements of efficacy will be determined by review of 3-D images from a Vectra H2 software by Canfield Scientific, Inc. measuring buttock volume difference in cc, angle formed at the inner gluteal vertex in degrees, and Height difference from the top to the bottom of the buttock in mm and surface area reduction calculations in cm2	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject satisfaction of subcutaneous fat treatment documented in written questionnaire	Subject satisfaction data will be collected at the 12-week final follow-up visit via a written questionnaire. A validated questionnaire using a likert rating scale will be utilized . Score values are 1 to 5, with high numbers meaning better outcomes.	12 weeks

Collaborators and Investigators

• Sponsor: Riverchase Dermatology
• Collaborators: Allergan
• Investigators: Principal Investigator: Leyda R Bowes, MD, Riverchase Dermatology

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2020
• Primary Completion (Anticipated): April 30, 2021
• Study Completion (Anticipated): May 30, 2021

Study Registration Dates

• First Submitted: July 31, 2020
• First Submitted That Met QC Criteria: September 11, 2020
• First Posted (Actual): September 17, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 14, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: reduction
• Other Study ID Numbers: Allergan IIT-2019-10713

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data will be summarized based on the nature of the data. Dichotomous (e.g., gender, independent photographic review) and ordinal (e.g., Fitzpatrick Skin type) data will be tabulated by category. The mean, standard error, maximum and minimum will be tabulated for continuous data (e.g., age). The significance level will be two-sided 0.05 for all statistical tests.
• IPD Sharing Time Frame: May 2021 for one year
• IPD Sharing Access Criteria: Direct request to team contact listed in Ct.gov
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No