N/A N=15 Treatment

Clinical Evaluation of CelluTite Treatment

Cellulite of Thighs

Bottom Line

View on ClinicalTrials.gov: NCT03769649 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2021

Primary outcome: Primary: Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples) — 2.45 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: CelluTite (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: InMode MD Ltd.
Primary completion: Jan 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)	1.9	—
PRIMARY Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)	0.4	—
PRIMARY Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)	2	—
PRIMARY Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)	2	—
PRIMARY Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)	2	—
PRIMARY Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)	1.9	—
PRIMARY Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)	1.9	—
PRIMARY Change in Cellulite Score Rated According to Cellulite Severity Scale (Dimples)	1.9	—
PRIMARY Change in Cellulite Score Rated According to Cellulite Severity Scale (Contour)	2	—
PRIMARY Assessment of Adverse Events Occurrence Based on Severity	—	—
PRIMARY Assessment of Adverse Events Occurrence Based on Severity	—	—
PRIMARY Assessment of Adverse Events Occurrence Based on Severity	—	—
PRIMARY Assessment of Adverse Events Occurrence Based on Severity	—	—
PRIMARY Assessment of Adverse Events Occurrence Based on Severity	—	—
PRIMARY Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)	0.4	—
PRIMARY Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)	0.4	—
PRIMARY Assessment of Occurrence of Adverse Events Based on Causality (Relationship to the Device or the Treatment)	0.4	—

Summary

This prospective study is intended to evaluate the CelluTite RFAL handpiece combined with Morpheus8 handpiece for the treatment of cellulite.

Eligibility Criteria

Inclusion Criteria

Female subjects aged 18-70 having mild/moderate grade cellulites.
The patients should understand the information provided about the treatment, possible benefits and side effects, and sign the Informed Consent Form, (including the permission to use photography).
The patients should be willing to comply with the study procedure and schedule, including the follow up visit, and will refrain from using any other aesthetic treatment methods in the treatment area for the last 6 months and during the entire study period.

Exclusion Criteria

Body fat layer thinner than 5mm.
Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
Superficial permanent implant in the treated area such as metal plates and screws, metal piercing, silicone implants or an injected chemical substance.
Current or history of skin cancer (remission of 5 years), or current condition of any other type of cancer, or pre-malignant moles.
Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
Pregnancy and nursing.
History of bleeding coagulopathies or use of anticoagulants.
Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or use of immunosuppressive medications.
Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction and hormonal virilization.
Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
Any surgery or treatment such as laser or chemicals in treated area within 3-6 months prior to treatment or before complete healing.
Allergies, in particular to anesthesia.
Mental disorders such as Body Dysmorphic Disorder (BDD).
As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03769649). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.