Clinical trial NCT04910945: Mechanical Coring to Achieve Directional Skin Tightening
Official title: Pilot Study for the Clinical Evaluation of Mechanical Coring to Achieve Directional Skin Tightening
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Skin Tightening
Healthy Volunteers
Keywords: Rhytides
Wrinkles
Loose Skin
Skin Laxity
Mechanical Coring
Robotic Coring
Skin Scarring
Scars
Stretch marks
Lead sponsor: Venus Concept
Sponsor class: INDUSTRY
First posted: 2021-06-02
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 3 center, multiple skin treatment area study of the safety and efficacy of mechanical coring with directional closure to achieve directional skin tightening.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Cores Successfully Removed by Coring Device
timeFrame: 1 day
Secondary outcomes:
measure: Downtime, as evaluated using the Subject Questionnaire
timeFrame: Up to Day 90 (end of study)
Other outcomes:
measure: Treatment pain
timeFrame: Day 1
Locations:
city: Los Altos
country: United States
facility: Berman Skin Institute
state: California
city: San Jose
country: United States
facility: Le's Aesthetics
state: California
city: Chicago
country: United States
facility: DeNova Research
state: Illinois
Study officials:
affiliation: Venus Concept
name: Matthew Gronski, PhD
role: STUDY_DIRECTOR
References: