Subcutaneous FatNCT04553627
Feasibility of Producing the Appearance of a Gluteal Lift Post Cryolipolysis
A study testing ZELTIQ thermoelectric device in people with Subcutaneous Fat, run by Riverchase Dermatology at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Subcutaneous Fat
- What is being tested?
- ZELTIQ thermoelectric device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2020to 30 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Subcutaneous Fat
- Being tested
- ZELTIQ thermoelectric device
- Keywords
- reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZELTIQ thermoelectric deviceDevice
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 group | Role | What they receive |
|---|---|---|
| Interventional cohort | Experimental | 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. Receives: Device: ZELTIQ thermoelectric device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 12 weeks
Secondary outcomes (1)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start15 Jul 2020
- Primary completion30 Apr 2021 (estimated)
- Study completion30 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subcutaneous FatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riverchase Dermatology
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Sponsor
- Investigators
- Leyda R Bowes, MD, Principal investigator, Riverchase Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553627
- Sponsor's protocol ID
- Allergan IIT-2019-10713
- Status last verified
- Oct 2020
- First submitted
- 31 Jul 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allergan IIT-2019-10713 Feasibility of Producing the Appearance of a Gluteal Lift Post Cryolipolysis
- ClinicalTrials.gov ID
- NCT04553627
- Acronym / sponsor ID
- Allergan IIT-2019-10713
- Conditions
- Subcutaneous Fat
- Keywords
- reduction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Riverchase DermatologyUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 May 2021 (estimated)
- First posted
- 17 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional cohort | Experimental | Device: ZELTIQ thermoelectric deviceZeltiq 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. |
Who may qualify
- Ages
- 22 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZELTIQ thermoelectric deviceThis 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 | Device | Interventional cohort |
Primary outcome
Incidence of treatment-emergent Adverse Events [Safety and Tolerability]
Time frame: 12 weeks
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.
Subjective clinical evaluation of subcutaneous fat treatment by Cryolipolysis [Efficacy]
Time frame: 12 weeks
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.
Aggregated measurements of subcutaneous fat treatment by Cryolipolysis [Efficacy]
Time frame: 12 weeks
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
1 secondary outcome
Subject satisfaction of subcutaneous fat treatment documented in written questionnaire
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leyda R Bowes, MD principal investigator
Riverchase Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ZELTIQ thermoelectric device in people with Subcutaneous Fat, run by Riverchase Dermatology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent Adverse Events [Safety and Tolerability] (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.