Mechanical Coring to Achieve Directional Skin Tightening

February 13, 2024 updated by: Venus Concept

Pilot Study for the Clinical Evaluation of Mechanical Coring to Achieve Directional Skin Tightening

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will evaluate the progress of up to 70 subjects after one treatment at up to 6 treatment areas on the body chosen from 2 on the neck (each treatment area approximately 1x3 cm), 2 on each underarm, 1 on each cheek, 2 on the abdomen, one on each thigh and 2 on the forehead area above the eyebrows (all approximately 6x4 cm). Subjects will be followed at 2, 5, 14, 28, 60, and 90 days after treatment.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Altos, California, United States, 94022
        • Recruiting
        • Berman Skin Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Berman, M.D.
      • San Jose, California, United States, 95112
        • Recruiting
        • Le's Aesthetics
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vincent Le
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Completed
        • DeNova Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Previous aesthetic (device and/or surgical) skin treatment in the treated areas (under arms and/or behind the ear) in the previous 6 months.
  2. 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.
  3. History of keloid formation
  4. Active smoker or having quit smoking in the last 3 months.
  5. Active, chronic, or recurrent infection
  6. Compromised immune and/or healing system (e.g. diabetes)
  7. Hypersensitivity/allergy to analgesic agents, Betadine, tumescent, Benzoin Tincture, Tegaderm or tensioning tape that will be used in the study.
  8. Co-morbid condition that could limit the ability to participate in the study or to comply with follow-up requirements.
  9. Pregnant or breastfeeding
  10. Any indication that may cause excessive bleeding, e.g., anticoagulants.
  11. Carcinoma, melanoma, or any other cancerous condition in the last 6 months.
  12. Allergy to adrenaline, epinephrine, or Tranexamic acid (TXA).
  13. Currently or in the last 1-month part of another clinical study of an investigational drug and/or experimental medical device
  14. Any issue that, at the discretion of the investigator would contra-indicate the subject's participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Micro-coring treatment
Device: VENUS AIME (RoboCor)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Cores Successfully Removed by Coring Device
Time Frame: 1 day
Percentage of cores successfully removed by the coring device without manual removal.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Downtime, as evaluated using the Subject Questionnaire
Time Frame: Up to Day 90 (end of study)
Made of 8 questions asking if subject felt self-conscious, covered up the treatment area, avoided people, unable to perform normal activities, felt pain, discomfort or itchiness. For each, the subject may answer 1) Not at all, 2) Some of the time, or 3) Most of the time. A lower score indicates a better result.
Up to Day 90 (end of study)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment pain
Time Frame: Day 1
Subject's assessment of discomfort and pain after treatments as measured by a VAS Pain Scale on 10 cm line. 0 cm being no pain/no discomfort and 10 cm being excruciating and unbearable pain.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Venus Concept

Investigators

  • Study Director: Matthew Gronski, PhD, Venus Concept

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2021

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

May 27, 2021

First Submitted That Met QC Criteria

May 27, 2021

First Posted (Actual)

June 2, 2021

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AI0620

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Volunteers

Clinical Trials on VENUS AIME (RoboCor)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe