WrinkleNCT05091788
Robotic Mechanical Coring for the Treatment of Moderate to Severe Facial Wrinkles
A study testing Venus Aime in people with Wrinkle, run by Venus Concept at 2 sites in United States.
Trial summary
This study is a prospective, up to 4 center study of the safety and efficacy of mechanical coring with skin closure of cored holes, intended for the improvement in the appearance of wrinkles of the cheeks in up to 70 subjects after two treatments. Read more about this study
- Who is it for?
- Ages 22 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkle
- What is being tested?
- Venus Aime
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Mar 2022to 15 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 22 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects between 22 and 75 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.
- Fitzpatrick skin type I to IV.
- Cheek areas are at least a score of 3 using the Lemperle Wrinkle Scale as judged by the Investigator.
Who cannot join
- Previous aesthetic (device and/or surgical) skin treatment (injection of dermal fillers, fat, or botulinum toxin), in the treated areas in the last 6 months.
- Silicone, Tattoos, body jewelry, that cannot be removed for the duration of treatment and/or any other synthetic material in the treatment area.
- Any type of scar in the treatment area
- Excessive sun exposure and use of tanning beds or tanning creams within 30 days to prior to treatment.
- History of keloid formation or hypertrophic scarring.
- Active smoker or having quit smoking in the last 3 months.
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- Active, chronic, or recurrent infection including Herpes simplex virus (HSV) infection or history of HSV in the last 6 months.
- Compromised immune and/or healing system (e.g., poorly controlled diabetes, collagen vascular disease or autoimmune diseases such as scleroderma, morphea, etc.).
- Hypersensitivity/allergy to analgesic agents, Betadine, tumescent, Tegaderm or tensioning tape that will be used in the study.
- Co-morbid condition that could limit the ability of the subject to participate in the study or to comply with follow-up requirements.
- Pregnant, planning pregnancy during the trial course or breastfeeding.
- History of bleeding disorder or taking medication that can potentially increase bleeding including anticoagulation.
- Carcinoma, melanoma, or any other cutaneous cancerous condition in the last 6 months.
- Non-cancerous lesions (e.g. actinic keratosis, vitiligo, cutaneous papules, nodules, active inflammatory lesions) in the region to be treated.
- Currently or in the last 1-month part of another clinical study of an investigational drug and/or experimental medical device.
- Any medical condition that, at the discretion of the investigator, would hamper the impact or the healing process and contra-indicate the subject's participation.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 1 recruiting
- Recruiting
Dermatology, Laser & Vein Specialists of the Carolinas, PLLC
Charlotte, North Carolina, 28207
Razia Ludin, 704-973-3687, razial@carolinaskin.com
Gilly Munavalli, MD
- Terminated
DeNova Research
Chicago, Illinois, 60611
About this study
Official title: Clinical Evaluation of the Safety and Efficacy of Aime Robotic Mechanical Coring Device for the Treatment of Moderate to Severe Facial Wrinkles
This study is a prospective, up to 4 center study of the safety and efficacy of mechanical coring with skin closure of cored holes, intended for the improvement in the appearance of wrinkles of the cheeks in up to 70 subjects after two treatments.
Read the detailed description
Prospective, up to 4 center study of the safety and efficacy of mechanical coring with Tegaderm tape skin closure of cored holes to achieve improvement in the appearance of wrinkles of the cheeks. The study will evaluate the progress of up to 70 subjects after two treatments on the cheeks. Up to 70 subjects who meet inclusion/exclusion criteria will be treated. All subjects will be monitored for a period 7, 37, 60 and 120 days post treatment.
- Conditions
- Wrinkle
- Being tested
- Venus Aime
- Keywords
- Wrinkles, Mechanical Coring, Robotic Coring, Skin Coring, Rhytides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venus AimeDevice
Also called Aime
Venus Aime is a micro-coring device of the skin that can potentially help reduce moderate to severe facial wrinkles.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | All subjects will receive two coring treatments on the cheeks with the robotic coring device. Receives: Device: Venus Aime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of correct identification of photograph sets from baseline and Day 120
Proportion of correct identification of photograph sets from baseline and Day 120 as assessed by independent blinded evaluators. This proportion of correct identification should be greater than completely random theoretical percentage of 0.5. Statistical significance (p<0.05) should be shown using one-sided binomial test comparing to 0.5.
Measured: 4 Months
Secondary outcomes (2)
Assess aesthetic improvement using Global Aesthetic Improvement Scale
Overall aesthetic improvement as assessed using the Global Aesthetic Improvement Scale (GAIS) by the Investigator at Day 120 compared to baseline
Very much improved (Optimal cosmetic result) = 5, Much Improved (Marked improvement from initial condition, but not completely optimal)=4, Improved (Obvious improvement in appearance from initial condition, but re-treatment is indicated)=3, No Change (The appearance is essentially the same as original condition)=2, Worse (The appearance is worse than the original condition)
Measured: 4 Months
Assess subject satisfaction post-treatment using Subject Satisfaction Scale
Subject satisfaction as assessed using the Subject Satisfaction Scale (SSS) completed by subjects on Day 120. Satisfaction with the aesthetic appearance of the treatment area.
Very Satisfied=4, Satisfied=3, Having No Opinion=2, Unsatisfied=1, Very Unsatisfied=0
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start22 Mar 2022
- Primary completion15 Aug 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinkleStudies 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
- NCT05091788
- Sponsor's protocol ID
- AI0321
- Status last verified
- Jan 2024
- First submitted
- 12 Oct 2021
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Safety and Efficacy of Aime Robotic Mechanical Coring Device for the Treatment of Moderate to Severe Facial Wrinkles
- ClinicalTrials.gov ID
- NCT05091788
- Acronym / sponsor ID
- AI0321
- Conditions
- Wrinkle
- Keywords
- Wrinkles, Mechanical Coring, Robotic Coring, Skin Coring, Rhytides
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Venus ConceptIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 15 Aug 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 25 Oct 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.
This study is a prospective, up to 4 center study of the safety and efficacy of mechanical coring with skin closure of cored holes, intended for the improvement in the appearance of wrinkles of the cheeks in up to 70 subjects after two treatments.
Detailed description
Prospective, up to 4 center study of the safety and efficacy of mechanical coring with Tegaderm tape skin closure of cored holes to achieve improvement in the appearance of wrinkles of the cheeks. The study will evaluate the progress of up to 70 subjects after two treatments on the cheeks. Up to 70 subjects who meet inclusion/exclusion criteria will be treated. All subjects will be monitored for a period 7, 37, 60 and 120 days post treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: Venus AimeAll subjects will receive two coring treatments on the cheeks with the robotic coring device. |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects between 22 and 75 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.
- Fitzpatrick skin type I to IV.
Key exclusion criteria (16 listed)
- Previous aesthetic (device and/or surgical) skin treatment (injection of dermal fillers, fat, or botulinum toxin), in the treated areas in the last 6 months.
- Silicone, Tattoos, body jewelry, that cannot be removed for the duration of treatment and/or any other synthetic material in the treatment area.
- Any type of scar in the treatment area
- Excessive sun exposure and use of tanning beds or tanning creams within 30 days to prior to treatment.
- History of keloid formation or hypertrophic scarring.
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 AimeAlso: AimeVenus Aime is a micro-coring device of the skin that can potentially help reduce moderate to severe facial wrinkles. | Device | Treatment Arm |
Primary outcome
Proportion of correct identification of photograph sets from baseline and Day 120
Time frame: 4 Months
Proportion of correct identification of photograph sets from baseline and Day 120 as assessed by independent blinded evaluators. This proportion of correct identification should be greater than completely random theoretical percentage of 0.5. Statistical significance (p<0.05) should be shown using one-sided binomial test comparing to 0.5.
2 secondary outcomes
Assess aesthetic improvement using Global Aesthetic Improvement Scale
Time frame: 4 Months
Assess subject satisfaction post-treatment using Subject Satisfaction Scale
Time frame: 4 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Individual participant dataSharing planned: No
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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
2 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 in people with Wrinkle, run by Venus Concept at 2 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 6 inclusion and 16 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 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Proportion of correct identification of photograph sets from baseline and Day 120 (time frame: 4 Months). 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 26 Jan 2024.