Skin TighteningNCT04910945
Mechanical Coring to Achieve Directional Skin Tightening
A study testing VENUS AIME (RoboCor) in people with Skin Tightening and Healthy Volunteers, run by Venus Concept at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Tightening, Healthy Volunteers
- What is being tested?
- VENUS AIME (RoboCor)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Feb 2021to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 2 recruiting
- Completed
DeNova Research
Chicago, Illinois, 60611
- Recruiting
Berman Skin Institute
Los Altos, California, 94022
David Berman, M.D., 650-325-6000, david.berman@skinmds.com
Anna Marte, (650) 325-6000, anna.marte@skinmds.com
- Recruiting
Le's Aesthetics
San Jose, California, 95112
Vincent Le, D.O., 408-835-9977, vle02@yahoo.com
Lin Phong, 408-835-9977, infohaircenters@gmail.com
About this study
Official title: Pilot Study for the Clinical Evaluation of Mechanical Coring to Achieve Directional Skin Tightening
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.
Read the 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.
- Conditions
- Skin Tightening, Healthy Volunteers
- Being tested
- VENUS AIME (RoboCor)
- Keywords
- Rhytides, Wrinkles, Loose Skin, Skin Laxity, Mechanical Coring, Robotic Coring, Skin Scarring, Scars, Stretch marks
- Medical subject headings
- Cutis Laxa, Cicatrix, Striae Distensae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VENUS AIME (RoboCor)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.
| Study group | Role | What they receive |
|---|---|---|
| Micro-coring treatment | Experimental | Not described Receives: Device: VENUS AIME (RoboCor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Cores Successfully Removed by Coring Device
Percentage of cores successfully removed by the coring device without manual removal.
Measured: 1 day
Secondary outcomes (1)
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.
Measured: Up to Day 90 (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start14 Feb 2021
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin TighteningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Venus Concept
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew Gronski, PhD, Study director, Venus Concept
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910945
- Sponsor's protocol ID
- AI0620
- Status last verified
- Feb 2024
- First submitted
- 27 May 2021
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for the Clinical Evaluation of Mechanical Coring to Achieve Directional Skin Tightening
- ClinicalTrials.gov ID
- NCT04910945
- Acronym / sponsor ID
- AI0620
- Conditions
- Skin Tightening, Healthy Volunteers
- Keywords
- Rhytides, Wrinkles, Loose Skin, Skin Laxity, Mechanical Coring, Robotic Coring, Skin Scarring, Scars
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Venus ConceptIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2021 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Micro-coring treatment | Experimental | Device: VENUS AIME (RoboCor) |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Micro-coring treatment |
Primary outcome
Percentage of Cores Successfully Removed by Coring Device
Time frame: 1 day
Percentage of cores successfully removed by the coring device without manual removal.
1 secondary outcome
Downtime, as evaluated using the Subject Questionnaire
Time frame: Up to Day 90 (end of study)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Gronski, PhD study director
Venus Concept
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VENUS AIME (RoboCor) in people with Skin Tightening and Healthy Volunteers, run by Venus Concept at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthew Gronski, PhD (888-907-0115, mgronski@venusconcept.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Cores Successfully Removed by Coring Device (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.