Mechanical Coring to Achieve Directional Skin Tightening

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-14

Study Completion Date

2025-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Skin Tightening Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Micro-coring treatment

Group Type EXPERIMENTAL

VENUS AIME (RoboCor)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes