Retrospective Evaluation of Cellulite o… | Clinical Trial

Key information

Conditions

Cellulite Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Dr. Mark Peters

Germantown, Tennessee, 38138, United States

About this study

The purpose of this preliminary report is to retrospectively evaluate this novel treatment approach to improve the appearance of cellulite on the thighs and buttocks by tightening the SFS using RFAL.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

age ≥ 18years of age at the time of procedure

patients with localized lipodystrophy in the medial or lateral thigh, and visible cellulite of laxity in the lower extremity or buttocks
BodyTite treatments performed from January 2018 - May 2019 for Cellulite indication

Exclusion criteria

active infection, collagen disorders, immunocompromised state, medications that mitigate inflammatory response, and propensity for keloid/hypertrophic scaring. o BodyTite treatments performed from March 2018 - May 2019 for lipodystrophy and cellulite of laxity

Treatment and study plan

BodyTite

Device

retrospectively evaluate this novel treatment approach to improve the appearance of cellulite on the thighs and buttocks by tightening the SFS using RFAL.

Primary outcomes

Photonumeric Cellulite Severity Score

Time frame: [ Time Frame: Baseline to 6 months posttreatment]

Change in Photonumeric Cellulite Severity Score 3. Investigator assessment of the cellulite improvement comparing pre and post treatment using Global aesthetic improvement 5-point grading scale (0=No change, 1=1%-24%%, 2=25%-49%, 3=50%-74% improvement, and 4=75%-100%) at all follow up visits.

Sponsors and collaborators

Lead sponsor

InMode MD Ltd.

Industry

Registry information

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Jun 5, 2020
Registry last updated: Aug 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed