Feasibility of Producing the Appearance of a Gluteal Lift Post Cryolipolysis

Status unconfirmed · Not applicable

Conditions studied: Subcutaneous Fat

In brief

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.

Key facts

Study ID

NCT04553627

Run by

Riverchase Dermatology

People needed

10

Starts

2020-07-15

Expected to finish

2021-05-30

Last updated by the study team

2020-10-19

Who can join

Age: 22 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Riverchase Dermatology — Miami, Florida, United States

Full record on ClinicalTrials.gov

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