Mechanical Coring to Achieve Directional Skin Tightening

NCT04910945 | Recruiting DMC FDA Device

• 1 other identifier: AI0620
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 3

Brief Summary

The objective of this clinical study is to evaluate the safety and efficacy of mechanical coring for directional skin tightening. This study is a prospective, up to 3 center, multiple skin treatment area study of the safety and efficacy of mechanical coring with directional closure to achieve directional skin tightening.

Conditions

Skin Tightening; Healthy Volunteers

Keywords

Rhytides; Wrinkles; Loose Skin; Skin Laxity; Mechanical Coring; Robotic Coring; Skin Scarring; Scars; Stretch marks

Outcome Measures

Primary Outcomes (1)

• Percentage of Cores Successfully Removed by Coring Device

  Percentage of cores successfully removed by the coring device without manual removal.

  1 day

Secondary Outcomes (1)

• Downtime, as evaluated using the Subject Questionnaire

  Up to Day 90 (end of study)

Other Outcomes (1)

• Treatment pain

  Day 1

Study Arms (1)

Micro-coring treatment

EXPERIMENTAL

Device: VENUS AIME (RoboCor)

Interventions

VENUS AIME (RoboCor) DEVICE

VENUS AIME is a micro-coring device of the skin that can potentially help to reduce visible skin scarring, improve skin laxity and reduce wrinkles.

Micro-coring treatment

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy, male or female subjects between 30 and 70 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.
• Subjects may have any Fitzpatrick skin type, however, no more than 35% of subjects may have Fitzpatrick skin type V or VI.

You may not qualify if:

• Previous aesthetic (device and/or surgical) skin treatment in the treated areas (under arms and/or behind the ear) in the previous 6 months.
• Fat, collagen, silicone, tattoos, body jewelry, that cannot be removed for the duration of treatment, and tegaderm/glue application or any other synthetic material in the treatment area.
• History of keloid formation
• Active smoker or having quit smoking in the last 3 months.
• Active, chronic, or recurrent infection
• Compromised immune and/or healing system (e.g. diabetes)
• Hypersensitivity/allergy to analgesic agents, Betadine, tumescent, Benzoin Tincture, Tegaderm or tensioning tape that will be used in the study.
• Co-morbid condition that could limit the ability to participate in the study or to comply with follow-up requirements.
• Pregnant or breastfeeding
• Any indication that may cause excessive bleeding, e.g., anticoagulants.
• Carcinoma, melanoma, or any other cancerous condition in the last 6 months.
• Allergy to adrenaline, epinephrine, or Tranexamic acid (TXA).
• Currently or in the last 1-month part of another clinical study of an investigational drug and/or experimental medical device
• Any issue that, at the discretion of the investigator would contra-indicate the subject's participation.

Sponsors & Collaborators

• Venus Concept: lead

Study Sites (3)

Berman Skin Institute

Los Altos, California, 94022, United States

RECRUITING

Le's Aesthetics

San Jose, California, 95112, United States

RECRUITING

DeNova Research

Chicago, Illinois, 60611, United States

COMPLETED

MeSH Terms

Conditions

Cutis Laxa; Cicatrix; Striae Distensae

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

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: May 27, 2021
• First Posted: June 2, 2021
• Study Start: February 14, 2021
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: February 14, 2024

Record last verified: 2024-02

Locations

US (3)