Clinical trial NCT06541899: Safety and Efficacy of Cryolipolysis Clinical Protocols
Official title: Safety and Efficacy of Cryolipolysis Clinical Protocols
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fat Loss
Keywords: Fat Loss
Weight Loss
Cryolipolysis
Lead sponsor: Indústria Brasileira Equipamentos Médicos - IBRAMED
Sponsor class: INDUSTRY
First posted: 2024-08-07
Enrollment: 395
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A single-arm, multicenter interventional clinical study will be conducted. The objective is to evaluate the safety and efficacy of the cryolipolysis technique. Approximately 372 participants will be included. After analyzing the items listed above, the participants in each study will be divided into 3 distinct intervention groups. The individuals included in the study will undergo anamnesis and data collection.

Detailed description: The participants in each study will be divided into 3 distinct intervention groups (Grupo 1: aplicador 360° M - Região abdominal; Grupo 2: aplicador 360° G - Região abdominal; Grupo 3: aplicador de placas - Região dos flancos). After analyzing the inclusion and exclusion criteria of this study, the individuals included in the study will undergo anamnesis and data collection after the procedure and 6 weeks and 20 weeks after: photographic capture, bioimpedance, perimetry, adipometry and ultrasound imaging of the treated area, in addition to a pain and patient satisfaction questionnaire.

Eligibility criteria: Inclusion Criteria:

* The participant (healthy volunteer) who has read and signed the informed consent form for the study.
* Male or female ≥ 22 years and ≤ 65 years of age.
* Subjects with a body mass index (BMI) of 30 or less and who have a greater volume of adipose tissue in the abdomen (except precordial region) and flanks.
* Subject has not changed in weight more than 5% of body weight in the previous month.
* Subject agrees to maintain his/her weight (i.e., within 5%) by not making major changes in his/her diet or exercise routine during the study.
* Subject agrees to have photographs taken of the treatment area(s) during the scheduled periods.

Exclusion Criteria:

* Diabetes mellitus or need to administer or known history of subcutaneous injections in the area of intended treatment (e.g. heparin, insulin) in the last month;
* Metabolic and/or liver diseases that compromise vitamin metabolism;
* Being pregnant or planning to become pregnant during the study period (within the next 8 months);
* Being breast-feeding or having breast-fed in the last 6 months;
* Having a known sensitivity to cold, such as cold urticaria, Raynaud\&#39;s disease, chilblains (pernio) or any known condition with a response to cold exposure that limits blood flow to the skin;
* Irritated skin or presence of dermatitis;
* Keloids or propensity for keloids in the area to be treated;
* Having a history of hernia in the area(s) to be treated.
* Any dermatological conditions, such as moderate to excessive skin laxity, or scarring at the location of the treatment sites that may interfere with treatment or evaluation (stretch marks are not an exclusion);
* Have a history of a bleeding disorder or are taking any medications that, in the opinion of the investigator, may increase the risk of bruising;
* Recent surgery at the treatment site;
* Regular use of anti-inflammatory medications;
* Are taking or have taken any pills or dietary supplements within the past month.
* Invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the intended treatment area;
* Implanted electronic devices (e.g., pacemaker);
* Are currently enrolled in a clinical trial of any unapproved investigational drug or device.
* Any other condition or laboratory value that could, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or pose an unacceptable risk to the subject.

Primary outcomes:
measure: Ocurrence of adverse events after de procedure assessed by clinical evaluation
timeFrame: After de procedure and 6 and 20 weeks after
measure: % reduction in fat layer assessed by ultrasound, adipometer and photography
timeFrame: Immediately after the procedure and 6 and 20 weeks after
Secondary outcomes:
measure: Patient"s satisfaction assessed by GAIS scale
timeFrame: 6 weeks and 20 weeks after the cryolipolysis procedure
Other outcomes:
Locations:
city: São Luís
country: Brazil
facility: UNDB
state: MA
city: Paranavai
country: Brazil
facility: Clinica Franciele Doneda Estetica Integrada
state: PR
city: São Paulo
country: Brazil
facility: UNIFAE
state: SP
Study officials:
References:
citation: Faulhaber J, Sandhofer M, Weiss C, Sattler G, Sadick NS. Effective noninvasive body contouring by using a combination of cryolipolysis, injection lipolysis, and shock waves. J Cosmet Dermatol. 2019 Aug;18(4):1014-1019. doi: 10.1111/jocd.12953. Epub 2019 Apr 13.
citation: Falster M, Schardong J, Santos DPD, Machado BC, Peres A, Rosa PVD, Plentz RDM. Effects of cryolipolysis on lower abdomen fat thickness of healthy women and patient satisfaction: a randomized controlled trial. Braz J Phys Ther. 2020 Sep-Oct;24(5):441-448. doi: 10.1016/j.bjpt.2019.07.005. Epub 2019 Jul 26.
citation: Dierickx CC, Mazer JM, Sand M, Koenig S, Arigon V. Safety, tolerance, and patient satisfaction with noninvasive cryolipolysis. Dermatol Surg. 2013 Aug;39(8):1209-16. doi: 10.1111/dsu.12238. Epub 2013 May 2.
citation: Coleman SR, Sachdeva K, Egbert BM, Preciado J, Allison J. Clinical efficacy of noninvasive cryolipolysis and its effects on peripheral nerves. Aesthetic Plast Surg. 2009 Jul;33(4):482-8. doi: 10.1007/s00266-008-9286-8. Epub 2009 Mar 19.
citation: Boey GE, Wasilenchuk JL. Fat reduction in the inner thigh using a prototype cryolipolysis applicator. Dermatol Surg. 2014 Sep;40(9):1004-9. doi: 10.1097/01.DSS.0000452628.99209.4f.
citation: Bernstein EF, Bloom JD, Basilavecchio LD, Plugis JM. Non-invasive fat reduction of the flanks using a new cryolipolysis applicator and overlapping, two-cycle treatments. Lasers Surg Med. 2014 Dec;46(10):731-5. doi: 10.1002/lsm.22302. Epub 2014 Nov 13.
citation: Bernstein EF, Bloom JD. Safety and Efficacy of Bilateral Submental Cryolipolysis With Quantified 3-Dimensional Imaging of Fat Reduction and Skin Tightening. JAMA Facial Plast Surg. 2017 Sep 1;19(5):350-357. doi: 10.1001/jamafacial.2017.0102.
citation: Abdel-Aal NM, Elerian AE, Elmakaky AM, Alhamaky DMA. Systemic Effects of Cryolipolysis in Central Obese Women: A Randomized Controlled Trial. Lasers Surg Med. 2020 Dec;52(10):971-978. doi: 10.1002/lsm.23250. Epub 2020 Apr 15.