Robotic Mechanical Coring for the Treatment of Moderate to Severe Facial Wrinkles

Clinical Evaluation of the Safety and Efficacy of Aime Robotic Mechanical Coring Device for the Treatment of Moderate to Severe Facial Wrinkles

This study is a prospective, up to 4 center study of the safety and efficacy of mechanical coring with skin closure of cored holes, intended for the improvement in the appearance of wrinkles of the cheeks in up to 70 subjects after two treatments.

Study Overview

• Status: Recruiting
• Conditions: Wrinkle
• Intervention / Treatment: Device: Venus Aime

Detailed Description

Prospective, up to 4 center study of the safety and efficacy of mechanical coring with Tegaderm tape skin closure of cored holes to achieve improvement in the appearance of wrinkles of the cheeks. The study will evaluate the progress of up to 70 subjects after two treatments on the cheeks. Up to 70 subjects who meet inclusion/exclusion criteria will be treated. All subjects will be monitored for a period 7, 37, 60 and 120 days post treatment.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthew Gronski, PhD; Phone Number: 888-907-0115; Email: mgronski@venusconcept.com

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Terminated
      • DeNova Research
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Recruiting
      • Dermatology, Laser & Vein Specialists of the Carolinas, PLLC
      • Contact: Razia Ludin; Phone Number: 704-973-3687; Email: raziaL@carolinaskin.com
      • Principal Investigator: Gilly Munavalli, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male or female subjects between 22 and 75 years of age.
2. Able to read, understand and voluntarily provide written Informed Consent.
3. Able and willing to comply with the treatment/follow-up schedule and requirements.
4. Women of childbearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study and have a negative Urine Pregnancy test at baseline.
5. Fitzpatrick skin type I to IV.
6. Cheek areas are at least a score of 3 using the Lemperle Wrinkle Scale as judged by the Investigator.

Exclusion Criteria:

1. Previous aesthetic (device and/or surgical) skin treatment (injection of dermal fillers, fat, or botulinum toxin), in the treated areas in the last 6 months.
2. Silicone, Tattoos, body jewelry, that cannot be removed for the duration of treatment and/or any other synthetic material in the treatment area.
3. Any type of scar in the treatment area
4. Excessive sun exposure and use of tanning beds or tanning creams within 30 days to prior to treatment.
5. History of keloid formation or hypertrophic scarring.
6. Active smoker or having quit smoking in the last 3 months.
7. Active, chronic, or recurrent infection including Herpes simplex virus (HSV) infection or history of HSV in the last 6 months.
8. Compromised immune and/or healing system (e.g., poorly controlled diabetes, collagen vascular disease or autoimmune diseases such as scleroderma, morphea, etc.).
9. Hypersensitivity/allergy to analgesic agents, Betadine, tumescent, Tegaderm or tensioning tape that will be used in the study.
10. Co-morbid condition that could limit the ability of the subject to participate in the study or to comply with follow-up requirements.
11. Pregnant, planning pregnancy during the trial course or breastfeeding.
12. History of bleeding disorder or taking medication that can potentially increase bleeding including anticoagulation.
13. Carcinoma, melanoma, or any other cutaneous cancerous condition in the last 6 months.
14. Non-cancerous lesions (e.g. actinic keratosis, vitiligo, cutaneous papules, nodules, active inflammatory lesions) in the region to be treated.
15. Currently or in the last 1-month part of another clinical study of an investigational drug and/or experimental medical device.
16. Any medical condition that, at the discretion of the investigator, would hamper the impact or the healing process and contra-indicate the subject's participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; All subjects will receive two coring treatments on the cheeks with the robotic coring device.	Device: Venus Aime; Venus Aime is a micro-coring device of the skin that can potentially help reduce moderate to severe facial wrinkles.; Other Names: Aime

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of correct identification of photograph sets from baseline and Day 120	Proportion of correct identification of photograph sets from baseline and Day 120 as assessed by independent blinded evaluators. This proportion of correct identification should be greater than completely random theoretical percentage of 0.5. Statistical significance (p<0.05) should be shown using one-sided binomial test comparing to 0.5.	4 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess aesthetic improvement using Global Aesthetic Improvement Scale	Overall aesthetic improvement as assessed using the Global Aesthetic Improvement Scale (GAIS) by the Investigator at Day 120 compared to baseline Very much improved (Optimal cosmetic result) = 5, Much Improved (Marked improvement from initial condition, but not completely optimal)=4, Improved (Obvious improvement in appearance from initial condition, but re-treatment is indicated)=3, No Change (The appearance is essentially the same as original condition)=2, Worse (The appearance is worse than the original condition)	4 Months
Assess subject satisfaction post-treatment using Subject Satisfaction Scale	Subject satisfaction as assessed using the Subject Satisfaction Scale (SSS) completed by subjects on Day 120. Satisfaction with the aesthetic appearance of the treatment area. Very Satisfied=4, Satisfied=3, Having No Opinion=2, Unsatisfied=1, Very Unsatisfied=0	4 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess subject's assessment of discomfort and pain using Visual Analogue Scale	Subjects' assessment of discomfort and pain after treatments as measured using the VAS Pain Scale immediately after treatment	1 day
Assess safety profile by recording adverse events	Subjects experiencing a treatment-related adverse event (AE) in the first 120 days post treatment.	4 Months

Collaborators and Investigators

• Sponsor: Venus Concept
• Investigators: Study Director: Matthew Gronski, PhD, Venus Concept

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2022
• Primary Completion (Estimated): August 15, 2025
• Study Completion (Estimated): August 15, 2025

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: October 12, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Actual): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Wrinkles; Rhytides; Mechanical Coring; Robotic Coring; Skin Coring
• Other Study ID Numbers: AI0321

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No