An interventional study of Renuvion APR System in Skin Laxity, sponsored by Apyx Medical. Completed at 1 site in Greece. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-26.
Sponsored by Apyx Medical · Not applicable, Interventional, and Treatment
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.
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.
At baseline, images will be taken utilizing the site's camera system. Baseline images will be used as comparator images for follow-up images for Independent Photographic Reviewer evaluation and subject/investigator assessments.
The treatment area will be tumesced with 20 - 25ml of fluid on each side of the periorbital area.
The treatment of the periorbital area will be accessed from an incision placed in the crease of the lower lid. Two incisions will be placed in both the medial and lateral crease of the lower lid. Treatment will be performed through one incision and the second incision will be used to allow for adequate venting of helium gas. Care will be taken to undermine the tissue and to ensure the incisions communicate with each other to allow adequate venting. An optional third lower lid incision may be made as needed. The treatment plane will be above the orbicularis muscle. The treatment settings will be 20% Power, 1 LPM, and 3 Passes. Procedure data and adverse events will be captured.
Follow-up will occur 1 day, 3 days, 7 days, 30 days, 90 days, and 180 days post-procedure; images will be taken at all visits. Investigator/subjects assessments will be completed at D30, D90, and D180 visits. Subjects may also be seen back for follow-up at the investigator's discretion.
Apyx Medical is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subject will be treated with the Renuvion APR system in the lower eyelid (periorbital) area.
Device: Renuvion APR System
The Renuvion Generator (K192867) is indicated for delivery of radiofrequency energy and/or helium plasma to cut, coagulate and ablate soft tissue during open and laparoscopic surgical procedures. The Renuvion APR Handpiece (K191542) is intended to be used with compatible electrosurgical generators for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. Together, the Renuvion Generator and Handpiece are referred to as the Renuvion APR System.
Day 180 Number of Participants With Improvement in Lower Eyelid Area as Determined by a Masked, Qualitative Assessment.
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.
Time frame: 180-Day
Day 90 Number of Participants With Improvement in the Lower Eyelid Area as Determined by a Masked, Qualitative Assessment.
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.
Time frame: 90-Day
Snap-Back Test Grade Analysis of Change From Baseline to Day 30
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 with blinking), Grade IV (never returns to original position and continues to hand down in frank ectropion after the snap-back test).
Time frame: 30-Day
Snap-Back Test Grade Analysis of Change From Baseline to Day 90
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 with blinking), Grade IV (never returns to original position and continues to hand down in frank ectropion after the snap-back test).
Time frame: 90-Day
Snap-Back Test Grade Analysis of Change From Baseline to Day 180
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 with blinking), Grade IV (never returns to original position and continues to hand down in frank ectropion after the snap-back test).
Time frame: 180-Day
Medical Canthal Laxity Test Analysis of Change From Baseline to Day 30
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).
Time frame: 30-Day
Medical Canthal Laxity Test Analysis of Change From Baseline to Day 90
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).
Time frame: 90-Day
Medical Canthal Laxity Test Analysis of Change From Baseline to Day 180
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).
Time frame: 180-Day
Lateral Canthal Laxity Test Analysis of Change From Baseline to Day 30
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).
Time frame: 30-Day
Lateral Canthal Laxity Test Analysis of Change From Baseline to Day 90
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).
Time frame: 90-Day
Lateral Canthal Laxity Test Analysis of Change From Baseline to Day 180
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).
Time frame: 180-Day
Subject Modified Global Aesthetic Improvement Scale (GAIS)
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.
Time frame: 90-Day
Subject Modified Global Aesthetic Improvement Scale (GAIS)
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.
Time frame: 180-Day
Investigator Modified Global Aesthetic Improvement Scale (GAIS)
The investigator will grade the overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, and very much worse.
Time frame: 90-Day
Investigator Modified Global Aesthetic Improvement Scale (GAIS)
The investigator will grade the overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, and very much worse.
Time frame: 180-Day
Day 180 Patient Satisfaction Questionnaire (PSQ)
At Day 180 Follow-Up visit, the study subjects will be asked to complete a subject satisfaction survey referring to the assessment of baseline photos, current photos, and a hand mirror. Yes/No - did you notice any improvement in your lower eyelid area? If yes, checkbox - improvement in wrinkles, less sagging skin, smother skin texture, other. How would you characterize your satisfaction with the treatment - very satisfied, satisfied, slightly satisfied, neither satisfied or dissatisfied, slightly dissatisfied, dissatisfied, very dissatisfied. Yes/No - would you recommend this treatment to your friends and family members.
Time frame: 180-Day
Average Pain at Procedure Day Reported by Subject
Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"
Time frame: Procedure Day 0 Following Study Treatment (within 60 minutes post procedure)
Average Pain at Day 1 Reported by Subject
Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"
Time frame: 1-Day
Average Pain at Day 3 Reported by Subject
Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"
Time frame: 3-Day
Average Pain at Day 7 Reported by Subject
Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"
Time frame: 7-Day
Average Pain at Day 30 Reported by Subject
Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"
Time frame: 30-Day
Average Pain at Day 90 Reported by Subject
Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"
Time frame: 90-Day
Average Pain at Day 180 Reported by Subject
Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"
Time frame: 180-Day
| Milestone | Renuvion APR System Treatment |
|---|---|
| Started | 16 |
| Completed | 15 |
| Not completed | 1 |
| Withdrew: Lost to follow-up | 1 |
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.
| Participants | Renuvion APR System Treatment |
|---|---|
| Day 180 Number of Participants With Improvement in Lower Eyelid Area as Determined by a Masked, Qualitative Assessment. | 5 |
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.
| Participants | Renuvion APR System Treatment |
|---|---|
| Day 90 Number of Participants With Improvement in the Lower Eyelid Area as Determined by a Masked, Qualitative Assessment. | 8 |
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 with blinking), Grade IV (never returns to original position and continues to hand down in frank ectropion after the snap-back test).
| Participants | Renuvion APR System Treatment |
|---|---|
| Grade 0 | 15 |
| Grade I | 0 |
| Grade II | 0 |
| Grade III | 0 |
| Grade IV | 0 |
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 with blinking), Grade IV (never returns to original position and continues to hand down in frank ectropion after the snap-back test).
| Participants | Renuvion APR System Treatment |
|---|---|
| Grade 0 | 15 |
| Grade I | 0 |
| Grade II | 0 |
| Grade III | 0 |
| Grade IV | 0 |
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 with blinking), Grade IV (never returns to original position and continues to hand down in frank ectropion after the snap-back test).
| Participants | Renuvion APR System Treatment |
|---|---|
| Grade 0 | 15 |
| Grade I | 0 |
| Grade II | 0 |
| Grade III | 0 |
| Grade IV | 0 |
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).
| Participants | Renuvion APR System Treatment |
|---|---|
| Grade 0 | 13 |
| Grade I | 2 |
| Grade II | 0 |
| Grade III | 0 |
| Grade IV | 0 |
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).
| Participants | Renuvion APR System Treatment |
|---|---|
| Grade 0 | 15 |
| Grade I | 0 |
| Grade II | 0 |
| Grade III | 0 |
| Grade IV | 0 |
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).
| Participants | Renuvion APR System Treatment |
|---|---|
| Grade 0 | 15 |
| Grade I | 0 |
| Grade II | 0 |
| Grade III | 0 |
| Grade IV | 0 |
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).
| Participants | Renuvion APR System Treatment |
|---|---|
| Grade 0 | 13 |
| Grade I | 2 |
| Grade II | 0 |
| Grade III | 0 |
| Grade IV | 0 |
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).
| Participants | Renuvion APR System Treatment |
|---|---|
| Grade 0 | 15 |
| Grade I | 0 |
| Grade II | 0 |
| Grade III | 0 |
| Grade IV | 0 |
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).
| Participants | Renuvion APR System Treatment |
|---|---|
| Grade 0 | 15 |
| Grade I | 0 |
| Grade II | 0 |
| Grade III | 0 |
| Grade IV | 0 |
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.
| Participants | Renuvion APR System Treatment |
|---|---|
| Very Much Improved | 14 |
| Much Improved | 1 |
| Improved | 0 |
| No Change | 0 |
| Worse | 0 |
| Much Worse | 0 |
| Very Much Worse | 0 |
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.
| Participants | Renuvion APR System Treatment |
|---|---|
| Very Much Improved | 10 |
| Much Improved | 5 |
| Improved | 0 |
| No Change | 0 |
| Worse | 0 |
| Much Worse | 0 |
| Very Much Worse | 0 |
The investigator will grade the overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, and very much worse.
| Participants | Renuvion APR System Treatment |
|---|---|
| Very Much Improved | 15 |
| Much Improved | 0 |
| Improved | 0 |
| No Change | 0 |
| Worse | 0 |
| Much Worse | 0 |
| Very Much Worse | 0 |
The investigator will grade the overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, and very much worse.
| Participants | Renuvion APR System Treatment |
|---|---|
| Very Much Improved | 14 |
| Much Improved | 1 |
| Improved | 0 |
| No Change | 0 |
| Worse | 0 |
| Much Worse | 0 |
| Very Much Worse | 0 |
At Day 180 Follow-Up visit, the study subjects will be asked to complete a subject satisfaction survey referring to the assessment of baseline photos, current photos, and a hand mirror. Yes/No - did you notice any improvement in your lower eyelid area? If yes, checkbox - improvement in wrinkles, less sagging skin, smother skin texture, other. How would you characterize your satisfaction with the treatment - very satisfied, satisfied, slightly satisfied, neither satisfied or dissatisfied, slightly dissatisfied, dissatisfied, very dissatisfied. Yes/No - would you recommend this treatment to your friends and family members.
| Participants | Renuvion APR System Treatment |
|---|---|
| Improvement Noticed — Yes | 15 |
| Improvement Noticed — No | 0 |
| Improvement in Wrinkles — Yes | 7 |
| Improvement in Wrinkles — No | 8 |
| Less Sagging Skin — Yes | 12 |
| Less Sagging Skin — No | 3 |
| Smoother Skin Texture — Yes | 11 |
| Smoother Skin Texture — No | 4 |
| Level of Satisfaction (Very Satisfied, Satisfied, Slightly Satisfied) — Yes | 15 |
| Level of Satisfaction (Very Satisfied, Satisfied, Slightly Satisfied) — No | 0 |
| Yes, would recommend to friends & family — Yes | 15 |
| Yes, would recommend to friends & family — No | 0 |
Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"
| Participants | Renuvion APR System Treatment |
|---|---|
| 0 | 16 |
| 1 | 0 |
| 2 | 0 |
| 3 | 0 |
| 4 | 0 |
| 5 | 0 |
| 6 | 0 |
| 7 | 0 |
| 8 | 0 |
| 9 | 0 |
| 10 | 0 |
Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"
| Participants | Renuvion APR System Treatment |
|---|---|
| 0 | 16 |
| 1 | 0 |
| 2 | 0 |
| 3 | 0 |
| 4 | 0 |
| 5 | 0 |
| 6 | 0 |
| 7 | 0 |
| 8 | 0 |
| 9 | 0 |
| 10 | 0 |
Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"
| Participants | Renuvion APR System Treatment |
|---|---|
| 0 | 16 |
| 1 | 0 |
| 2 | 0 |
| 3 | 0 |
| 4 | 0 |
| 5 | 0 |
| 6 | 0 |
| 7 | 0 |
| 8 | 0 |
| 9 | 0 |
| 10 | 0 |
Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"
| Participants | Renuvion APR System Treatment |
|---|---|
| 0 | 16 |
| 1 | 0 |
| 2 | 0 |
| 3 | 0 |
| 4 | 0 |
| 5 | 0 |
| 6 | 0 |
| 7 | 0 |
| 8 | 0 |
| 9 | 0 |
| 10 | 0 |
Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"
| Participants | Renuvion APR System Treatment |
|---|---|
| 0 | 15 |
| 1 | 0 |
| 2 | 0 |
| 3 | 0 |
| 4 | 0 |
| 5 | 0 |
| 6 | 0 |
| 7 | 0 |
| 8 | 0 |
| 9 | 0 |
| 10 | 0 |
Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"
| Participants | Renuvion APR System Treatment |
|---|---|
| 0 | 15 |
| 1 | 0 |
| 2 | 0 |
| 3 | 0 |
| 4 | 0 |
| 5 | 0 |
| 6 | 0 |
| 7 | 0 |
| 8 | 0 |
| 9 | 0 |
| 10 | 0 |
Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain"
| Participants | Renuvion APR System Treatment |
|---|---|
| 0 | 15 |
| 1 | 0 |
| 2 | 0 |
| 3 | 0 |
| 4 | 0 |
| 5 | 0 |
| 6 | 0 |
| 7 | 0 |
| 8 | 0 |
| 9 | 0 |
| 10 | 0 |
Collected over Through Day 180 follow-up visit.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Renuvion APR System Treatment | 0/16 (0%) | 0/16 (0%) | 14/16 (87.5%) |
| Event | Renuvion APR System Treatment |
|---|---|
| Bruise (ETE)Skin and subcutaneous tissue disorders | 14/16 |
| Edema (ETE)Skin and subcutaneous tissue disorders | 13/16 |
| Contact DermatitisSkin and subcutaneous tissue disorders | 1/16 |
| Age, Continuous(Years) | Renuvion APR System Treatment |
|---|---|
| Mean | 48.1 ± 9.3 |
| Sex: Female, Male(Participants) | Renuvion APR System Treatment |
|---|---|
| Female | 13 |
| Male | 3 |
| Race (NIH/OMB)(Participants) | Renuvion APR System Treatment |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 16 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Renuvion APR System Treatment |
|---|---|
| Greece | 16 |
| NRS for Pain(Participants) | Renuvion APR System Treatment |
|---|---|
| 0 | 16 |
| 1 | 0 |
| 2 | 0 |
| 3 | 0 |
| 4 | 0 |
| 5 | 0 |
| 6 | 0 |
| 7 | 0 |
| 8 | 0 |
| 9 | 0 |
| 10 | 0 |
| Snap-Back Test Grade(Participants) | Renuvion APR System Treatment |
|---|---|
| Grade 0 | 0 |
| Grade I | 9 |
| Grade II | 3 |
| Grade III | 4 |
| Grade IV | 0 |
| Medial Canthal Laxity Test Grade(Participants) | Renuvion APR System Treatment |
|---|---|
| Grade 0 | 1 |
| Grade I | 14 |
| Grade II | 1 |
| Grade III | 0 |
| Grace IV | 0 |
| Lateral Canthal Laxity Test Grade(Participants) | Renuvion APR System Treatment |
|---|---|
| Grade 0 | 1 |
| Grade I | 14 |
| Grade II | 1 |
| Grade III | 0 |
| Grade IV | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Oct 2022 to primary completion in Mar 2024, 16 months.
Results were first posted in Mar 2025, 1 year after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Cutis Laxa
Apyx Medical