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Procedure

Robotic Mechanical Coring for Wrinkles

N/A
Recruiting
Research Sponsored by Venus Concept
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female subjects between 22 and 75 years of age.
Male or female subjects between 22 and 75 years of age
Must not have
Non-cancerous lesions (e.g. actinic keratosis, vitiligo, cutaneous papules, nodules, active inflammatory lesions) in the region to be treated
History of bleeding disorder or taking medication that can potentially increase bleeding including anticoagulation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new treatment for cheek wrinkles that uses a device to remove tiny pieces of skin and covers them with special tape to help them heal. It aims to improve skin appearance by making it smoother. Up to 70 people will be treated and monitored over time.

Who is the study for?
This trial is for men and women aged 22-75 with moderate to severe cheek wrinkles, rated at least a 3 on the Lemperle Wrinkle Scale. Participants must have Fitzpatrick skin type I to IV, use reliable birth control if applicable, and commit to the study schedule. Smokers, those with recent aesthetic treatments or certain medical conditions are excluded.
What is being tested?
The Venus Aime procedure is being tested for its safety and effectiveness in reducing facial wrinkles. This involves mechanical coring of the skin followed by closure of cored areas. Up to 70 subjects will receive two treatments in this prospective study across up to four centers.
What are the potential side effects?
Potential side effects may include discomfort at treatment sites, risk of infection, scarring or changes in skin pigmentation. There might also be reactions related to analgesics used during the procedure or materials involved in closing cored holes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 22 and 75 years old.
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I am between 22 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have non-cancerous skin conditions in the area that needs treatment.
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I have a bleeding disorder or take medication that increases bleeding risk.
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I have a scar in the area that needs treatment.
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I haven't had cosmetic skin treatments like fillers or Botox in the last 6 months.
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I have had an active or recurrent herpes infection in the last 6 months.
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I don't have silicone, tattoos, or non-removable body jewelry in the treatment area.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of correct identification of photograph sets from baseline and Day 120
Secondary study objectives
Assess aesthetic improvement using Global Aesthetic Improvement Scale
Assess subject satisfaction post-treatment using Subject Satisfaction Scale
Other study objectives
Assess safety profile by recording adverse events
Assess subject's assessment of discomfort and pain using Visual Analogue Scale

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
All subjects will receive two coring treatments on the cheeks with the robotic coring device.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for wrinkles include laser resurfacing, chemical peels, dermabrasion, and mechanical coring with skin closure. These treatments primarily work by inducing controlled injury to the skin, which stimulates the body's natural healing processes, including collagen production and skin remodeling. For example, mechanical coring removes small cores of skin tissue, prompting the skin to produce new collagen and tighten, thereby reducing the appearance of wrinkles. This is crucial for wrinkle patients as increased collagen leads to improved skin elasticity and a more youthful appearance.
Carbon dioxide laser treatment promotes repair of the three-dimensional network of elastic fibres in rat skin.

Find a Location

Who is running the clinical trial?

Venus ConceptLead Sponsor
34 Previous Clinical Trials
1,254 Total Patients Enrolled
3 Trials studying Wrinkles
50 Patients Enrolled for Wrinkles
Matthew Gronski, PhDStudy DirectorVenus Concept
4 Previous Clinical Trials
203 Total Patients Enrolled

Media Library

Robotic Mechanical Coring (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05091788 — N/A
Wrinkles Research Study Groups: Treatment Arm
Wrinkles Clinical Trial 2023: Robotic Mechanical Coring Highlights & Side Effects. Trial Name: NCT05091788 — N/A
Robotic Mechanical Coring (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05091788 — N/A
Wrinkles Patient Testimony for trial: Trial Name: NCT05091788 — N/A
~16 spots leftby Aug 2025