Status:
RECRUITING
Mechanical Coring to Achieve Directional Skin Tightening
Lead Sponsor:
Venus Concept
Conditions:
Skin Tightening
Healthy Volunteers
Eligibility:
All Genders
30-70 years
Phase:
NA
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 a...
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 und...
Eligibility Criteria
Inclusion
- 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 35% of subjects may have Fitzpatrick skin type V or VI.
Exclusion
- 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, Betadine, tumescent, Benzoin Tincture, Tegaderm or tensioning tape that will be used in the study.
- 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.
Key Trial Info
Start Date :
February 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04910945
Start Date
February 14 2021
End Date
August 31 2025
Last Update
February 14 2024
Active Locations (3)
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1
Berman Skin Institute
Los Altos, California, United States, 94022
2
Le's Aesthetics
San Jose, California, United States, 95112
3
DeNova Research
Chicago, Illinois, United States, 60611