Adults 18 to 75, any sex, with Skin Laxity. 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.
Day 180 Number of Participants With Improvement in Lower Eyelid Area as Determined by a Masked, Qualitative Assessment.Primary· 180-Day
Improvement in the lower eyelid area as determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline by blinded independent reviewers. Improvement will be assessed based on photographs taken at all visits using the site's 2D camera system.
Group
Value
95% CI
Renuvion APR System Treatment
5
Day 90 Number of Participants With Improvement in the Lower Eyelid Area as Determined by a Masked, Qualitative Assessment.Secondary· 90-Day
Improvement in the lower eyelid area as determined by a masked, qualitative assessment of photographs at 90-days post-treatment compared to baseline by blinded independent reviewers. Improvement will be assessed based on photographs taken at all visits using the site's 2D camera system.
Group
Value
95% CI
Renuvion APR System Treatment
8
Snap-Back Test Grade Analysis of Change From Baseline to Day 30Secondary· 30-Day
This test provides relative lower lid laxity. In normal lids, the skin snaps-back to the original position immediately; the longer it takes, the more laxity is present. To perform the snap-back test, pull the lower lid away and down from globe for several seconds and wait to see how long it returns to the original position without the subject blinking. Grade 0 (Normal lid that returns to position immediately on release), Grade I (Approx 2-3 seconds to return to original position), Grade II (4-5 seconds to return to original position), Grade III (\>5 seconds but does return to original position
Group
Value
95% CI
Renuvion APR System Treatment
15
Renuvion APR System Treatment
0
Renuvion APR System Treatment
0
Renuvion APR System Treatment
0
Snap-Back Test Grade Analysis of Change From Baseline to Day 90Secondary· 90-Day
This test provides relative lower lid laxity. In normal lids, the skin snaps-back to the original position immediately; the longer it takes, the more laxity is present. To perform the snap-back test, pull the lower lid away and down from globe for several seconds and wait to see how long it returns to the original position without the subject blinking. Grade 0 (Normal lid that returns to position immediately on release), Grade I (Approx 2-3 seconds to return to original position), Grade II (4-5 seconds to return to original position), Grade III (\>5 seconds but does return to original position
Group
Value
95% CI
Renuvion APR System Treatment
15
Renuvion APR System Treatment
0
Renuvion APR System Treatment
0
Renuvion APR System Treatment
0
Snap-Back Test Grade Analysis of Change From Baseline to Day 180Secondary· 180-Day
This test provides relative lower lid laxity. In normal lids, the skin snaps-back to the original position immediately; the longer it takes, the more laxity is present. To perform the snap-back test, pull the lower lid away and down from globe for several seconds and wait to see how long it returns to the original position without the subject blinking. Grade 0 (Normal lid that returns to position immediately on release), Grade I (Approx 2-3 seconds to return to original position), Grade II (4-5 seconds to return to original position), Grade III (\>5 seconds but does return to original position
Group
Value
95% CI
Renuvion APR System Treatment
15
Renuvion APR System Treatment
0
Renuvion APR System Treatment
0
Renuvion APR System Treatment
0
Medical Canthal Laxity Test Analysis of Change From Baseline to Day 30Secondary· 30-Day
This test provides medial canthal laxity by means of measuring displacement. The greater the distance, the more the laxity. To perform the medial canthal laxity test, pull the lower lid laterally away from the medial canthus and measure displacement of medial punctum. Grade 0 (\<2mm displacement), Grade I (approx 2mm displacement), Grade II (approx 3mm displacement), Grade III (\>3mm displacement), Grade IV (does not return to baseline after release and blinking).
Group
Value
95% CI
Renuvion APR System Treatment
13
Renuvion APR System Treatment
2
Renuvion APR System Treatment
0
Renuvion APR System Treatment
0
Medical Canthal Laxity Test Analysis of Change From Baseline to Day 90Secondary· 90-Day
This test provides medial canthal laxity by means of measuring displacement. The greater the distance, the more the laxity. To perform the medial canthal laxity test, pull the lower lid laterally away from the medial canthus and measure displacement of medial punctum. Grade 0 (\<2mm displacement), Grade I (approx 2mm displacement), Grade II (approx 3mm displacement), Grade III (\>3mm displacement), Grade IV (does not return to baseline after release and blinking).
Group
Value
95% CI
Renuvion APR System Treatment
15
Renuvion APR System Treatment
0
Renuvion APR System Treatment
0
Renuvion APR System Treatment
0
Medical Canthal Laxity Test Analysis of Change From Baseline to Day 180Secondary· 180-Day
This test provides medial canthal laxity by means of measuring displacement. The greater the distance, the more the laxity. To perform the medial canthal laxity test, pull the lower lid laterally away from the medial canthus and measure displacement of medial punctum. Grade 0 (\<2mm displacement), Grade I (approx 2mm displacement), Grade II (approx 3mm displacement), Grade III (\>3mm displacement), Grade IV (does not return to baseline after release and blinking).
Group
Value
95% CI
Renuvion APR System Treatment
15
Renuvion APR System Treatment
0
Renuvion APR System Treatment
0
Renuvion APR System Treatment
0
Lateral Canthal Laxity Test Analysis of Change From Baseline to Day 30Secondary· 30-Day
This test provides lateral canthal laxity by means of measuring displacement. The greater the distance, the more the laxity. To perform the lateral canthal laxity test, pull the lower lid medially away from the lateral canthus and measure displacement of lateral canthal corner. Grade 0 (\<2mm displacement), Grade I (2-4mm displacement), Grade II (4-6mm displacement), Grade III (\>6mm displacement), Grade IV (does not return to baseline after release and blinking).
Group
Value
95% CI
Renuvion APR System Treatment
13
Renuvion APR System Treatment
2
Renuvion APR System Treatment
0
Renuvion APR System Treatment
0
Lateral Canthal Laxity Test Analysis of Change From Baseline to Day 90Secondary· 90-Day
This test provides lateral canthal laxity by means of measuring displacement. The greater the distance, the more the laxity. To perform the lateral canthal laxity test, pull the lower lid medially away from the lateral canthus and measure displacement of lateral canthal corner. Grade 0 (\<2mm displacement), Grade I (2-4mm displacement), Grade II (4-6mm displacement), Grade III (\>6mm displacement), Grade IV (does not return to baseline after release and blinking).
Group
Value
95% CI
Renuvion APR System Treatment
15
Renuvion APR System Treatment
0
Renuvion APR System Treatment
0
Renuvion APR System Treatment
0
Lateral Canthal Laxity Test Analysis of Change From Baseline to Day 180Secondary· 180-Day
This test provides lateral canthal laxity by means of measuring displacement. The greater the distance, the more the laxity. To perform the lateral canthal laxity test, pull the lower lid medially away from the lateral canthus and measure displacement of lateral canthal corner. Grade 0 (\<2mm displacement), Grade I (2-4mm displacement), Grade II (4-6mm displacement), Grade III (\>6mm displacement), Grade IV (does not return to baseline after release and blinking).
Group
Value
95% CI
Renuvion APR System Treatment
15
Renuvion APR System Treatment
0
Renuvion APR System Treatment
0
Renuvion APR System Treatment
0
Subject Modified Global Aesthetic Improvement Scale (GAIS)Secondary· 90-Day
The subject will grade the overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, and very much worse.
Group
Value
95% CI
Renuvion APR System Treatment
14
Renuvion APR System Treatment
1
Renuvion APR System Treatment
0
Renuvion APR System Treatment
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Through Day 180 follow-up visit..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a prospective, multi-center, non-randomized, single-arm study of up to 15 subjects treated with the Renuvion APR System. Subjects will receive treatment with the Renuvion APR System in the lower periorbital area on both sides of the face.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Apyx Medical
Last refreshed: 26 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05605691.