NCT03078647

Profound Dermal and SubQ Cartridges for the Treatment of Cellulite

Completed NA Results posted Last updated 25 June 2019

What this trial tests

NA trial testing Profound in Cellulite in 31 participants. Completed in 31 January 2019.

Timeline

13 September 2017

Primary endpoint
2 November 2018

31 January 2019

Quick facts

Lead sponsor	Syneron Medical
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	31
Start date	13 September 2017
Primary completion	2 November 2018
Estimated completion	31 January 2019
Sites	2 locations across United States

Drugs / interventions tested

• Profound

Conditions studied

• Cellulite — all drugs for Cellulite →

Sponsor

Syneron Medical

Who can join

Adults 18 to 60, female only, with Cellulite. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Improvement in Global Aesthetic Appearance of Cellulite in Treated Areas, as Assessed by Study Investigator Evaluations Primary · 1,3 and 6 months post-treatment

Evaluate the improvement in global aesthetic appearance of cellulite in treated areas following a single dermal and/or subcutaneous treatment with Profound, as assessed by study investigators at 1,3 and 6 months post treatment visit. Investigators used the following scale: 0=No Change; 1= 1-24% improvement; 2=25-49% improvement; 3=50-74% improvement; 4=75-100% improvement. The analysis calculates the improvement over 25% (grades 2-4)

Over 25% Improvement at 1 month FU

Group	Value	95% CI
Treated on the Suprapatellar	11
Treated on the Upper Arms	7
Treated on the Braline	4

Over 25% Improvement at 3 month FU

Group	Value	95% CI
Treated on the Suprapatellar	16
Treated on the Upper Arms	10
Treated on the Braline	5

Over 25% Improvement at 6 month FU

Group	Value	95% CI
Treated on the Suprapatellar	15
Treated on the Upper Arms	9
Treated on the Braline	4

Improvement in Skin Tightening/Laxity in Treated Areas, as Assessed by Study Investigator Evaluations Secondary · 1, 3 and 6 months post treatment visit.

Evaluate the improvement in skin tightening in treated areas following a single dermal and/or subcutaneous treatment with Profound, as assessed by study investigators at 1 and 6 months post treatment visit. Investigators used the following scale: (0) No tightening/firmness; (1) Slightly visible tightening/firmness; (2) Visible tightening/firmness; (3) Very visible tightening/firmness. The analysis calculates the skin tightening improvement graded: (2) Visible tightening/firmness and (3) Very visible tightening/firmness

Visible + very visible tightening at 1-month FU

Group	Value	95% CI
Treated on the Suprapatellar	9
Treated on the Upper Arms	3
Treated on the Braline	4

Visible + very visible tightening at 3-month FU

Group	Value	95% CI
Treated on the Suprapatellar	14
Treated on the Upper Arms	8
Treated on the Braline	4

Visible + very visible tightening at 6-month FU

Group	Value	95% CI
Treated on the Suprapatellar	15
Treated on the Upper Arms	8
Treated on the Braline	4

Investigator Satisfaction - by Questionnaire Secondary · 1, 3, and 6 months post-treatment visit

Evaluate Investigator satisfaction at 1, 3, and 6 months post-treatment visit, using a satisfaction scale \[(-2) Very dissatisfied, (-1) Dissatisfied, (0) No opinion, (1) Satisfied, (2) Very satisfied\]. The analysis quantify investigator satisfaction (grades 1-2)

Investigator Satisfaction Grades 1-2 at 1mo FU

Group	Value	95% CI
Treated on the Suprapatellar	13
Treated on the Upper Arms	8
Treated on the Braline	4

Investigator Satisfaction Grades 1-2 at 3mo FU

Group	Value	95% CI
Treated on the Suprapatellar	21
Treated on the Upper Arms	10
Treated on the Braline	4

Investigator Satisfaction Grades 1-2 at 6mo FU

Group	Value	95% CI
Treated on the Suprapatellar	17
Treated on the Upper Arms	9
Treated on the Braline	4

Subject Satisfaction and Improvement - by Questionnaire Secondary · 1, 3, and 6 months post-treatment visit

Evaluate subject satisfaction at 1, 3, and 6 months post-treatment visit, using a satisfaction and improvement scale \[(-2) Very dissatisfied, (-1) Dissatisfied, (0) No opinion, (1) Satisfied, (2) Very satisfied\]. The analysis quantify subject satisfaction (grades 1-2)

Subject Satisfaction Grades 1-2 at 1mo FU

Group	Value	95% CI
Treated on the Suprapatellar	13
Treated on the Upper Arms	8
Treated on the Braline	2

Subject Satisfaction Grades 1-2 at 3mo FU

Group	Value	95% CI
Treated on the Suprapatellar	20
Treated on the Upper Arms	10
Treated on the Braline	2

Subject Satisfaction Grades 1-2 at 6mo FU

Group	Value	95% CI
Treated on the Suprapatellar	17
Treated on the Upper Arms	10
Treated on the Braline	4

Adverse events — posted to ClinicalTrials.gov

Time frame: The period of time over which adverse event data were collected is from treatment visit until 6 month post treatment. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treated on the Suprapatellar

Serious: 0/17 (0%)

Deaths: 0/17

Treated on the Upper Arms

Serious: 0/11 (0%)

Deaths: 0/11

Treated on the Braline

Serious: 0/3 (0%)

Deaths: 0/3

Other adverse events (2 terms — click to expand)

Reaction	System	Treated on the Suprapatellar	Treated on the Upper Arms	Treated on the Braline
Bruising	Skin and subcutaneous tissue disorders	—	—	—
Itching	Skin and subcutaneous tissue disorders	—	—	—

Data from ClinicalTrials.gov NCT03078647 adverse events section.

Sponsor's own description

Clinical Study to Evaluate the Performance of the Profound System for the Treatment of Cellulite.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Single Treatment Protocol With Microneedle Fractional Radiofrequency for Treatment of Body Skin Laxity and Fat Deposits.
   Alexiades M, Munavalli GS. · · 2021 · cited 7× · PMID 33764552 · DOI 10.1002/lsm.23397