Trial Outcomes & Findings for Profound Dermal and SubQ Cartridges for the Treatment of Cellulite (NCT NCT03078647)

Last Updated: 2019-06-25

Results Overview

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)

Recruitment status

COMPLETED

Study phase

Target enrollment

31 participants

Primary outcome timeframe

1,3 and 6 months post-treatment

Results posted on

2019-06-25

Participant Flow

Participant milestones

Participant milestones
Measure	Treated on the Suprapatellar Subjects treated with the Profound Dermal, SubQ or both cartridges above the knees areas (on both left and right sides)	Treated on the Upper Arms Subjects treated with the Profound Dermal, SubQ or both cartridges on the upper arms (on both left and right sides)	Treated on the Braline Subjects treated with the Profound Dermal, SubQ or both cartridges on the braline areas (on both left and right sides)
Overall Study STARTED	17	11	3
Overall Study COMPLETED	17	10	3
Overall Study NOT COMPLETED	0	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Profound Dermal and SubQ Cartridges for the Treatment of Cellulite

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 1,3 and 6 months post-treatment

Population: Suprapatellar areas- 17 subjects, 8 subjects (16 areas) had one assessment for both sides treated with the same parameters. Upper Arms- 10 Subjects had one assessment for both sides treated with same parameters (1 subject dropped after 1 wk FU). Braline areas- 3 subjects, one subject had one assessment for both sides treated with same parameters

Outcome measures

Outcome measures
Measure	Treated on the Suprapatellar n=26 Investigator Assessments Subjects treated with the Profound Dermal, SubQ or both cartridges above the knees areas (on both the left and the right side)	Treated on the Upper Arms n=10 Investigator Assessments Subjects treated with the Profound Dermal, SubQ or both cartridges on the upper arms (on both the left and the right side)	Treated on the Braline n=5 Investigator Assessments Subjects treated with the Profound Dermal, SubQ or both cartridges on the braline areas (on both the left and the right side)
Improvement in Global Aesthetic Appearance of Cellulite in Treated Areas, as Assessed by Study Investigator Evaluations Over 25% Improvement at 1 month FU	11 Investigator Assessments	7 Investigator Assessments	4 Investigator Assessments
Improvement in Global Aesthetic Appearance of Cellulite in Treated Areas, as Assessed by Study Investigator Evaluations Over 25% Improvement at 3 month FU	16 Investigator Assessments	10 Investigator Assessments	5 Investigator Assessments
Improvement in Global Aesthetic Appearance of Cellulite in Treated Areas, as Assessed by Study Investigator Evaluations Over 25% Improvement at 6 month FU	15 Investigator Assessments	9 Investigator Assessments	4 Investigator Assessments

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Treated on the Suprapatellar n=17 Participants Subjects treated with the Profound Dermal, SubQ or both cartridges above the knees areas (on both the left and the right side)	Treated on the Upper Arms n=10 Investigator Assessments Subjects treated with the Profound Dermal, SubQ or both cartridges on the upper arms (on both the left and the right side)	Treated on the Braline n=5 Investigator Assessments Subjects treated with the Profound Dermal, SubQ or both cartridges on the braline areas (on both the left and the right side)
Improvement in Skin Tightening/Laxity in Treated Areas, as Assessed by Study Investigator Evaluations Visible + very visible tightening at 1-month FU	9 Investigator Assessments	3 Investigator Assessments	4 Investigator Assessments
Improvement in Skin Tightening/Laxity in Treated Areas, as Assessed by Study Investigator Evaluations Visible + very visible tightening at 3-month FU	14 Investigator Assessments	8 Investigator Assessments	4 Investigator Assessments
Improvement in Skin Tightening/Laxity in Treated Areas, as Assessed by Study Investigator Evaluations Visible + very visible tightening at 6-month FU	15 Investigator Assessments	8 Investigator Assessments	4 Investigator Assessments

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Treated on the Suprapatellar n=26 Investigator Assessments Subjects treated with the Profound Dermal, SubQ or both cartridges above the knees areas (on both the left and the right side)	Treated on the Upper Arms n=10 Investigator Assessments Subjects treated with the Profound Dermal, SubQ or both cartridges on the upper arms (on both the left and the right side)	Treated on the Braline n=5 Investigator Assessments Subjects treated with the Profound Dermal, SubQ or both cartridges on the braline areas (on both the left and the right side)
Investigator Satisfaction - by Questionnaire Investigator Satisfaction Grades 1-2 at 1mo FU	13 Investigator Assessments	8 Investigator Assessments	4 Investigator Assessments
Investigator Satisfaction - by Questionnaire Investigator Satisfaction Grades 1-2 at 3mo FU	21 Investigator Assessments	10 Investigator Assessments	4 Investigator Assessments
Investigator Satisfaction - by Questionnaire Investigator Satisfaction Grades 1-2 at 6mo FU	17 Investigator Assessments	9 Investigator Assessments	4 Investigator Assessments

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Treated on the Suprapatellar n=26 Subject Assessments Subjects treated with the Profound Dermal, SubQ or both cartridges above the knees areas (on both the left and the right side)	Treated on the Upper Arms n=10 Subject Assessments Subjects treated with the Profound Dermal, SubQ or both cartridges on the upper arms (on both the left and the right side)	Treated on the Braline n=5 Subject Assessments Subjects treated with the Profound Dermal, SubQ or both cartridges on the braline areas (on both the left and the right side)
Subject Satisfaction and Improvement - by Questionnaire Subject Satisfaction Grades 1-2 at 1mo FU	13 Subject Assessments	8 Subject Assessments	2 Subject Assessments
Subject Satisfaction and Improvement - by Questionnaire Subject Satisfaction Grades 1-2 at 3mo FU	20 Subject Assessments	10 Subject Assessments	2 Subject Assessments
Subject Satisfaction and Improvement - by Questionnaire Subject Satisfaction Grades 1-2 at 6mo FU	17 Subject Assessments	10 Subject Assessments	4 Subject Assessments

Adverse Events

Treated on the Suprapatellar

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Treated on the Upper Arms

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treated on the Braline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treated on the Suprapatellar n=17 participants at risk Subjects treated with the Profound Dermal, SubQ or both cartridges above the knees areas (on both the left and the right side)	Treated on the Upper Arms n=11 participants at risk Subjects treated with the Profound Dermal, SubQ or both cartridges on the upper arms (on both the left and the right side)	Treated on the Braline n=3 participants at risk Subjects treated with the Profound Dermal, SubQ or both cartridges on the braline areas (on both the left and the right side)
Skin and subcutaneous tissue disorders Bruising	5.9% 1/17 • Number of events 1 • The period of time over which adverse event data were collected is from treatment visit until 6 month post treatment The number and severity of adverse events following a single dermal and subcutaneous treatment, with Profound for the Suprapatellar, upper arms or braline, were evaluated at 1-week post treatment, 1 month, 3 and 6 months following the treatment.	0.00% 0/11 • The period of time over which adverse event data were collected is from treatment visit until 6 month post treatment The number and severity of adverse events following a single dermal and subcutaneous treatment, with Profound for the Suprapatellar, upper arms or braline, were evaluated at 1-week post treatment, 1 month, 3 and 6 months following the treatment.	0.00% 0/3 • The period of time over which adverse event data were collected is from treatment visit until 6 month post treatment The number and severity of adverse events following a single dermal and subcutaneous treatment, with Profound for the Suprapatellar, upper arms or braline, were evaluated at 1-week post treatment, 1 month, 3 and 6 months following the treatment.
Skin and subcutaneous tissue disorders Itching	5.9% 1/17 • Number of events 1 • The period of time over which adverse event data were collected is from treatment visit until 6 month post treatment The number and severity of adverse events following a single dermal and subcutaneous treatment, with Profound for the Suprapatellar, upper arms or braline, were evaluated at 1-week post treatment, 1 month, 3 and 6 months following the treatment.	0.00% 0/11 • The period of time over which adverse event data were collected is from treatment visit until 6 month post treatment The number and severity of adverse events following a single dermal and subcutaneous treatment, with Profound for the Suprapatellar, upper arms or braline, were evaluated at 1-week post treatment, 1 month, 3 and 6 months following the treatment.	0.00% 0/3 • The period of time over which adverse event data were collected is from treatment visit until 6 month post treatment The number and severity of adverse events following a single dermal and subcutaneous treatment, with Profound for the Suprapatellar, upper arms or braline, were evaluated at 1-week post treatment, 1 month, 3 and 6 months following the treatment.

Additional Information

Director of Clinical Marketing

Candela Corporation

Phone: (949) 599-7646

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Treated on the Suprapatellar n=34 Number Areas Subjects treated with the Profound Dermal, SubQ or both cartridges above the knees areas (on both the left and the right side)	Treated on the Upper Arms n=22 Number Areas Subjects treated with the Profound Dermal, SubQ or both cartridges on the upper arms (on both the left and the right side)	Treated on the Braline n=6 Number Areas Subjects treated with the Profound Dermal, SubQ or both cartridges on the braline areas (on both the left and the right side)	Total n=62 Number Areas Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	11 Participants n=7 Participants	3 Participants n=5 Participants	31 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	49.4 years STANDARD_DEVIATION 8.8 • n=5 Participants	53.8 years STANDARD_DEVIATION 6.8 • n=7 Participants	46.7 years STANDARD_DEVIATION 14.6 • n=5 Participants	50.7 years STANDARD_DEVIATION 8.8 • n=4 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	11 Participants n=7 Participants	3 Participants n=5 Participants	31 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants	11 Participants n=7 Participants	3 Participants n=5 Participants	31 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	11 Participants n=7 Participants	3 Participants n=5 Participants	31 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	17 participants n=5 Participants	11 participants n=7 Participants	3 participants n=5 Participants	31 participants n=4 Participants