Clinical trial NCT04553627: Feasibility of Producing the Appearance of a Gluteal Lift Post Cryolipolysis
Official title: Allergan IIT-2019-10713 Feasibility of Producing the Appearance of a Gluteal Lift Post Cryolipolysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Subcutaneous Fat
Keywords: reduction
Lead sponsor: Riverchase Dermatology
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2020-09-17
Enrollment: 10
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of treatment-emergent Adverse Events [Safety and Tolerability]
timeFrame: 12 weeks
measure: Subjective clinical evaluation of subcutaneous fat treatment by Cryolipolysis [Efficacy]
timeFrame: 12 weeks
measure: Aggregated measurements of subcutaneous fat treatment by Cryolipolysis [Efficacy]
timeFrame: 12 weeks
Secondary outcomes:
measure: Subject satisfaction of subcutaneous fat treatment documented in written questionnaire
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: Riverchase Dermatology
state: Florida
Study officials:
affiliation: Riverchase Dermatology
name: Leyda R Bowes, MD
role: PRINCIPAL_INVESTIGATOR
References: