Mechanical Coring to Achieve Directional Skin Tightening

Sponsor

Venus Concept (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04910945

Collaborator

(none)

Enrollment

Locations

27.5

Anticipated Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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 three center, multiple skin treatment area study of the safety and efficacy of mechanical coring with directional closure to achieve directional skin tightening. The study will evaluate the progress of up to 40 subjects after one treatment at up to 6 treatment areas on the body (two on each underarm and one periauricular). Subjects will be followed at 2, 7, 14, 28, 60 and 90 days after treatment.

Condition or Disease	Intervention/Treatment	Phase
Skin Tightening Healthy Volunteers	Device: VENUS AIME (RoboCor)	N/A

Detailed Description

Prospective, up to three center, multiple skin treatment area study of the safety and efficacy of mechanical coring with directional closure to achieve directional skin tightening. The study will evaluate the progress of up to 40 subjects after one treatment at up to 6 treatment areas on the body (two on each underarm and one periauricular). Subjects will be followed at 2, 7, 14, 28, 60 and 90 days after treatment. Analysis will be performed on all subjects.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 14, 2021

Anticipated Primary Completion Date :

May 31, 2022

Anticipated Study Completion Date :

May 31, 2023

Outcome Measures

Primary Outcome Measures

Percentage of Skin Tightening [3 Months]
Percentage of directional skin tightening achieved at each of the skin treatment sites by day 7, 14, 28, 60 and 90 based on the change in the area defined by tattoo marks.

Secondary Outcome Measures

Percentage of Cores Successfully Removed by Coring Device [1 day]
Percentage of cores successfully removed by the coring device without manual removal.

Other Outcome Measures

Visual Analog Scale (VAS) Pain Scale [1 day]
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.
Treatment Related Adverse Event (AE) [3 Month]
Subjects experiencing a treatment-related adverse event (AE) in the first 90 days post-treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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 25% of subjects may have Fitzpatrick skin type V or VI.

Exclusion Criteria:

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.
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.