Trial Outcomes & Findings for Histological Evaluation of Human Skin Bx to Assess the Effects of APR Tx as an Adjunct Procedure in Facelift Surgery (NCT NCT06243744)
NCT ID: NCT06243744
Last Updated: 2026-03-24
Results Overview
To assess Elasticity (collagen \& elastin) evaluation will be based on the qualitative histology in samples at baseline and Day 180 follow-up. Two samples from each time period were analyses - control and treatment area. The H\&E, trichrome, and van Gieson-stained slides were evaluated via light microscopy for any abnormalities and extracellular matrix changes. The results of histopathological assessment were scored using the industry standard 5-point scoring system. 0=Normal, 1=Minimal, 2=Mild, 3=Moderate, 4=Severe.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
Baseline, Day 180
Results posted on
2026-03-24
Participant Flow
Unit of analysis: Facial treatment area (within-subject)
Participant milestones
| Measure |
Renuvion APR System (Lower Face)
Lower facial region treated with the Renuvion APR System during lower facelift surgery. Treatment was applied to the neck, submentum, and lower facial skin flap.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
Untreated Control (Mid/Upper Face)
Mid and upper facial regions that did not receive Renuvion treatment and served as within-subject controls.
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|---|---|---|
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Overall Study
STARTED
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7 7
|
7 7
|
|
Overall Study
COMPLETED
|
6 6
|
6 6
|
|
Overall Study
NOT COMPLETED
|
1 1
|
1 1
|
Reasons for withdrawal
| Measure |
Renuvion APR System (Lower Face)
Lower facial region treated with the Renuvion APR System during lower facelift surgery. Treatment was applied to the neck, submentum, and lower facial skin flap.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
Untreated Control (Mid/Upper Face)
Mid and upper facial regions that did not receive Renuvion treatment and served as within-subject controls.
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|---|---|---|
|
Overall Study
Subject Missed Day 180 visit
|
1
|
1
|
Baseline Characteristics
Histological Evaluation of Human Skin Bx to Assess the Effects of APR Tx as an Adjunct Procedure in Facelift Surgery
Baseline characteristics by cohort
| Measure |
Procedure With the Renuvion APR System in Lower Facelift Area
n=7 Participants
Subjects will receive a lower facelift surgery per the Investigator's standard clinical practice and treatment with the Renuvion APR System. Baseline Characteristics are reported once due to the split body design.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
|---|---|
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Age, Continuous
|
55.4 years
STANDARD_DEVIATION 6.4 • n=138 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=138 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=138 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=138 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=138 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=138 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=138 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 180To assess Elasticity (collagen \& elastin) evaluation will be based on the qualitative histology in samples at baseline and Day 180 follow-up. Two samples from each time period were analyses - control and treatment area. The H\&E, trichrome, and van Gieson-stained slides were evaluated via light microscopy for any abnormalities and extracellular matrix changes. The results of histopathological assessment were scored using the industry standard 5-point scoring system. 0=Normal, 1=Minimal, 2=Mild, 3=Moderate, 4=Severe.
Outcome measures
| Measure |
Treatment Area
n=7 Participants
Subjects will receive a lower facelift surgery per the Investigator's standard clinical practice and treatment with the Renuvion APR System.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
Control
n=7 Participants
The upper face area was not treated with Renuvion and served as the untreated control.
|
|---|---|---|
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Analysis of Elasticity (Collagen & Elastin)
Histological Findings Collagen Deposition Baseline
|
1.7 units on a scale
Interval 0.0 to 4.0
|
0.5 units on a scale
Interval 0.0 to 4.0
|
|
Analysis of Elasticity (Collagen & Elastin)
Histological Findings Collagen Deposition D180
|
1.5 units on a scale
Interval 0.0 to 4.0
|
0.5 units on a scale
Interval 0.0 to 4.0
|
|
Analysis of Elasticity (Collagen & Elastin)
Histological Findings Elastin Density Baseline
|
2.3 units on a scale
Interval 2.0 to 3.0
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2.2 units on a scale
Interval 2.0 to 3.0
|
|
Analysis of Elasticity (Collagen & Elastin)
Histological Findings Elastin Density D180
|
3 units on a scale
Interval 2.0 to 4.0
|
2.3 units on a scale
Interval 2.0 to 4.0
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PRIMARY outcome
Timeframe: Post-Treatment, Day 1, 7, 14, 45, 90, 180Analysis days of duration of overall facial bruising and swelling post-treatment through the 180-day visit. The reported data is for the lower face treatment area only; the control area was not evaluated for bruising/swelling.
Outcome measures
| Measure |
Treatment Area
n=7 Participants
Subjects will receive a lower facelift surgery per the Investigator's standard clinical practice and treatment with the Renuvion APR System.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
Control
The upper face area was not treated with Renuvion and served as the untreated control.
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|---|---|---|
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Analyzing Days of Duration for Bruising, Swelling
With Bruising D180
|
0 participants
|
—
|
|
Analyzing Days of Duration for Bruising, Swelling
With Brusing D1
|
6 participants
|
—
|
|
Analyzing Days of Duration for Bruising, Swelling
With Bruising D7
|
5 participants
|
—
|
|
Analyzing Days of Duration for Bruising, Swelling
With Bruising D14
|
5 participants
|
—
|
|
Analyzing Days of Duration for Bruising, Swelling
With Bruising D45
|
0 participants
|
—
|
|
Analyzing Days of Duration for Bruising, Swelling
With Bruising D90
|
0 participants
|
—
|
|
Analyzing Days of Duration for Bruising, Swelling
With Swelling D1
|
7 participants
|
—
|
|
Analyzing Days of Duration for Bruising, Swelling
With Swelling D7
|
7 participants
|
—
|
|
Analyzing Days of Duration for Bruising, Swelling
With Swelling D14
|
6 participants
|
—
|
|
Analyzing Days of Duration for Bruising, Swelling
With Swelling D45
|
0 participants
|
—
|
|
Analyzing Days of Duration for Bruising, Swelling
With Swelling D90
|
0 participants
|
—
|
|
Analyzing Days of Duration for Bruising, Swelling
With Swelling D180
|
0 participants
|
—
|
PRIMARY outcome
Timeframe: Post-Treatment, Day 1, 7, 14, 45, 90, 180Percentage of the lower facial treatment area assessed as healed at each post-treatment time frame (Days 1, 7, 14, 45, 90 \& 180) based on investigator clinical evaluation documented in Case Report Forms. The reported data is for the lower face treatment area only; the control untreated mid/upper-face area was not evaluated for healing.
Outcome measures
| Measure |
Treatment Area
n=7 Participants
Subjects will receive a lower facelift surgery per the Investigator's standard clinical practice and treatment with the Renuvion APR System.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
Control
The upper face area was not treated with Renuvion and served as the untreated control.
|
|---|---|---|
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Percentage of Lower Face Area Healed
D1
|
17.5 percentage of lower facial area healed
Standard Deviation 16.6
|
—
|
|
Percentage of Lower Face Area Healed
D7
|
40.0 percentage of lower facial area healed
Standard Deviation 28.9
|
—
|
|
Percentage of Lower Face Area Healed
D14
|
47.5 percentage of lower facial area healed
Standard Deviation 28.9
|
—
|
|
Percentage of Lower Face Area Healed
D45
|
70.8 percentage of lower facial area healed
Standard Deviation 17.4
|
—
|
|
Percentage of Lower Face Area Healed
D90
|
92.1 percentage of lower facial area healed
Standard Deviation 6.4
|
—
|
|
Percentage of Lower Face Area Healed
D180
|
99.8 percentage of lower facial area healed
Standard Deviation 0.4
|
—
|
PRIMARY outcome
Timeframe: During Procedure (Day 0)Analysis of bleeding during surgery measured in cubic centimeter. The reported data is for the lower face treatment area only; the control area was not evaluated for bleeding.
Outcome measures
| Measure |
Treatment Area
n=7 Participants
Subjects will receive a lower facelift surgery per the Investigator's standard clinical practice and treatment with the Renuvion APR System.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
Control
The upper face area was not treated with Renuvion and served as the untreated control.
|
|---|---|---|
|
Bleeding
15cc Blood Loss
|
2 Participants
|
—
|
|
Bleeding
20cc Blood Loss
|
2 Participants
|
—
|
|
Bleeding
70cc Blood Loss
|
1 Participants
|
—
|
|
Bleeding
75cc Blood Loss
|
1 Participants
|
—
|
|
Bleeding
300cc Blood Loss
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 180Global Aesthetic Improvement Scale Evaluation (PGAIS) rating by investigator \[Very much improved, Much improved, Improved, No change, Worse, Much Worse, Very much Worse\]. The reported data is for the lower face treatment area only; the control area was not evaluated for GAIS as it was not treated.
Outcome measures
| Measure |
Treatment Area
n=6 Participants
Subjects will receive a lower facelift surgery per the Investigator's standard clinical practice and treatment with the Renuvion APR System.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
Control
The upper face area was not treated with Renuvion and served as the untreated control.
|
|---|---|---|
|
The Principal Investigator Will Complete a PGAIS Assessing Overall Aesthetic Improvement in the Treatment Area at Day 180 Post-treatment.
Worse, Much Worse, Very Much Worse
|
0 Participants
|
—
|
|
The Principal Investigator Will Complete a PGAIS Assessing Overall Aesthetic Improvement in the Treatment Area at Day 180 Post-treatment.
No Change
|
0 Participants
|
—
|
|
The Principal Investigator Will Complete a PGAIS Assessing Overall Aesthetic Improvement in the Treatment Area at Day 180 Post-treatment.
Improved, Much Improved, Very Much Improved
|
6 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 180Subject Global Aesthetic Improvement Scale Evaluation (SGAIS) rating by subject \[Very much improved, Much improved, Improved, No change, Worse, Much Worse, Very much Worse\]. The reported data is for the lower face treatment area only; the control area was not evaluated for GAIS as it was not treated.
Outcome measures
| Measure |
Treatment Area
n=6 Participants
Subjects will receive a lower facelift surgery per the Investigator's standard clinical practice and treatment with the Renuvion APR System.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
Control
The upper face area was not treated with Renuvion and served as the untreated control.
|
|---|---|---|
|
The Subject Will Complete a SGAIS Assessing Overall Aesthetic Improvement in the Treatment Area at Day 180 Post-treatment.
Worse, Much Worse, Very Much Worse
|
0 Participants
|
—
|
|
The Subject Will Complete a SGAIS Assessing Overall Aesthetic Improvement in the Treatment Area at Day 180 Post-treatment.
No Change
|
0 Participants
|
—
|
|
The Subject Will Complete a SGAIS Assessing Overall Aesthetic Improvement in the Treatment Area at Day 180 Post-treatment.
Improved, Much Improved, Very Much Improved
|
6 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 180The subject will complete a Patient Satisfaction Questionnaire (PSQ) while referring to their image in a mirror and current post-treatment photos compared to baseline photos to rate how satisfied they are, and if they note any improvement in the treatment area. The reported data is for the lower face treatment area only; the control area was not evaluated for PSQ as it was not treated.
Outcome measures
| Measure |
Treatment Area
n=6 Participants
Subjects will receive a lower facelift surgery per the Investigator's standard clinical practice and treatment with the Renuvion APR System.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
Control
The upper face area was not treated with Renuvion and served as the untreated control.
|
|---|---|---|
|
Patient Satisfaction
Noticed Improvement in the Lower Face
|
6 participants
|
—
|
|
Patient Satisfaction
Satisfied with Procedure
|
6 participants
|
—
|
|
Patient Satisfaction
Would Recommend to Friends & Family
|
6 participants
|
—
|
|
Patient Satisfaction
Noted Improved Skin Dryness
|
1 participants
|
—
|
|
Patient Satisfaction
Noted Improved Elasticity
|
3 participants
|
—
|
|
Patient Satisfaction
Noted Skin Quality Improved
|
2 participants
|
—
|
|
Patient Satisfaction
Noted Skin Appears More Youthful
|
5 participants
|
—
|
|
Patient Satisfaction
Noted Improved Skin Radiance
|
3 participants
|
—
|
Adverse Events
Procedure With the Renuvion APR System in Lower Facelift Area
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Untreated Control (Upper Face)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Procedure With the Renuvion APR System in Lower Facelift Area
n=7 participants at risk
Subjects will receive a lower facelift surgery per the Investigator's standard clinical practice and treatment with the Renuvion APR System.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
Untreated Control (Upper Face)
n=7 participants at risk
The upper face area served as the untreated control.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Bruise (ETE)
|
85.7%
6/7 • Number of events 6 • Adverse events (AEs) and expected treatment effects (ETEs) were recorded during treatment and monitored up to the Day 180 visit.
Adverse events (AEs) and expected treatment effects (ETEs) were recorded during treatment and monitored up to the Day 180 visit.
|
0.00%
0/7 • Adverse events (AEs) and expected treatment effects (ETEs) were recorded during treatment and monitored up to the Day 180 visit.
Adverse events (AEs) and expected treatment effects (ETEs) were recorded during treatment and monitored up to the Day 180 visit.
|
|
Skin and subcutaneous tissue disorders
Edema (ETE)
|
100.0%
7/7 • Number of events 7 • Adverse events (AEs) and expected treatment effects (ETEs) were recorded during treatment and monitored up to the Day 180 visit.
Adverse events (AEs) and expected treatment effects (ETEs) were recorded during treatment and monitored up to the Day 180 visit.
|
0.00%
0/7 • Adverse events (AEs) and expected treatment effects (ETEs) were recorded during treatment and monitored up to the Day 180 visit.
Adverse events (AEs) and expected treatment effects (ETEs) were recorded during treatment and monitored up to the Day 180 visit.
|
|
Skin and subcutaneous tissue disorders
Seroma
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) and expected treatment effects (ETEs) were recorded during treatment and monitored up to the Day 180 visit.
Adverse events (AEs) and expected treatment effects (ETEs) were recorded during treatment and monitored up to the Day 180 visit.
|
0.00%
0/7 • Adverse events (AEs) and expected treatment effects (ETEs) were recorded during treatment and monitored up to the Day 180 visit.
Adverse events (AEs) and expected treatment effects (ETEs) were recorded during treatment and monitored up to the Day 180 visit.
|
|
Skin and subcutaneous tissue disorders
Focal Skin Breakdown
|
14.3%
1/7 • Number of events 1 • Adverse events (AEs) and expected treatment effects (ETEs) were recorded during treatment and monitored up to the Day 180 visit.
Adverse events (AEs) and expected treatment effects (ETEs) were recorded during treatment and monitored up to the Day 180 visit.
|
0.00%
0/7 • Adverse events (AEs) and expected treatment effects (ETEs) were recorded during treatment and monitored up to the Day 180 visit.
Adverse events (AEs) and expected treatment effects (ETEs) were recorded during treatment and monitored up to the Day 180 visit.
|
Additional Information
Kari Larson, Sr. Director, Clinical Affairs
Apyx Medical
Phone: 800-537-2790
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place