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

NCT05091788 | Unknown FDA Device

• 1 other identifier: AI0321
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Wrinkle

Keywords

Wrinkles; Mechanical Coring; Robotic Coring; Skin Coring; Rhytides

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Assess aesthetic improvement using Global Aesthetic Improvement Scale

  4 Months

• Assess subject satisfaction post-treatment using Subject Satisfaction Scale

  4 Months

Other Outcomes (2)

• Assess subject's assessment of discomfort and pain using Visual Analogue Scale

  1 day

• Assess safety profile by recording adverse events

  4 Months

Study Arms (1)

Treatment Arm

EXPERIMENTAL

All subjects will receive two coring treatments on the cheeks with the robotic coring device.

Device: Venus Aime

Interventions

Venus Aime DEVICE

Venus Aime is a micro-coring device of the skin that can potentially help reduce moderate to severe facial wrinkles.

Also known as: Aime

Treatment Arm

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects between 22 and 75 years of age.
• Able to read, understand and voluntarily provide written Informed Consent.
• Able and willing to comply with the treatment/follow-up schedule and requirements.
• 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.
• Fitzpatrick skin type I to IV.
• Cheek areas are at least a score of 3 using the Lemperle Wrinkle Scale as judged by the Investigator.

You may not qualify if:

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

Sponsors & Collaborators

• Venus Concept: lead

Study Sites (2)

DeNova Research

Chicago, Illinois, 60611, United States

TERMINATED

Dermatology, Laser & Vein Specialists of the Carolinas, PLLC

Charlotte, North Carolina, 28207, United States

RECRUITING

Study Officials

• Matthew Gronski, PhD

  Venus Concept

  STUDY DIRECTOR

Central Study Contacts

Matthew Gronski, PhD

CONTACT

888-907-0115; mgronski@venusconcept.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 25, 2021
• Study Start: March 22, 2022
• Primary Completion: August 15, 2025
• Study Completion: August 15, 2025
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)