Mechanical Coring to Achieve Directional Skin Tightening

Last updated: February 13, 2024
Sponsor: Venus Concept
Overall Status: Active - Recruiting

Phase

N/A

Condition

Healthy Volunteers

Treatment

VENUS AIME (RoboCor)

Clinical Study ID

NCT04910945
AI0620
  • Ages 30-70
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 controlat least 3 months prior to study enrollment and for the duration of the study and havea negative Urine Pregnancy test at baseline.
  5. Subjects may have any Fitzpatrick skin type, however, no more than 35% of subjects mayhave Fitzpatrick skin type V or VI.

Exclusion

Exclusion Criteria:

  1. Previous aesthetic (device and/or surgical) skin treatment in the treated areas (underarms and/or behind the ear) in the previous 6 months.
  2. Fat, collagen, silicone, tattoos, body jewelry, that cannot be removed for theduration of treatment, and tegaderm/glue application or any other synthetic materialin 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 tocomply 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 investigationaldrug and/or experimental medical device
  14. Any issue that, at the discretion of the investigator would contra-indicate thesubject's participation.

Study Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: VENUS AIME (RoboCor)
Phase:
Study Start date:
February 14, 2021
Estimated Completion Date:
August 31, 2025

Study 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.

Connect with a study center

  • Berman Skin Institute

    Los Altos, California 94022
    United States

    Active - Recruiting

  • Le's Aesthetics

    San Jose, California 95112
    United States

    Active - Recruiting

  • DeNova Research

    Chicago, Illinois 60611
    United States

    Completed

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