Mechanical Coring to Achieve Directional Skin Tightening

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04910945
• Other study ID #: AI0620
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2021
• Est. completion date: August 31, 2025

Study information

• Verified date: February 2024
• Source: Venus Concept
• Contact: Matthew Gronski, PhD
• Phone: 888-907-0115
• Email: mgronski[@]venusconcept.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers
• Skin Tightening

Intervention

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.

Locations

Country	Name	City	State
United States	DeNova Research	Chicago	Illinois
United States	Berman Skin Institute	Los Altos	California
United States	Le's Aesthetics	San Jose	California

Sponsors (1)

Lead Sponsor	Collaborator
Venus Concept

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment pain	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
Primary	Percentage of Cores Successfully Removed by Coring Device	Percentage of cores successfully removed by the coring device without manual removal.	1 day
Secondary	Downtime, as evaluated using the Subject Questionnaire	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)