What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for wrinkles, such as laser resurfacing, radiofrequency treatments, and injectable fillers, can have several side effects. Laser resurfacing may cause thermal injury, leading to redness, swelling, and a prolonged recovery period. Radiofrequency treatments can result in minor and temporary side effects like a slight burning sensation and mild erythema, which typically resolve within an hour. Injectable fillers might cause localized reactions such as redness, swelling, and bruising at the injection site. More invasive procedures like mechanical coring with skin closure may also carry risks of infection, scarring, and prolonged healing times.

What prior FDA approvals exist?

The FDA has approved several treatments for wrinkles that focus on stimulating collagen production and skin tightening. Injectable fillers such as hyaluronic acid (e.g., Juvéderm, Restylane) and poly-L-lactic acid (e.g., Sculptra) are commonly used to fill in wrinkles and stimulate collagen production. Laser treatments, including nonablative lasers like fractional lasers, have also been approved for skin resurfacing and wrinkle reduction by promoting collagen remodeling. These treatments share similarities with the mechanical coring with skin closure method, as they aim to enhance skin texture and elasticity through collagen stimulation.

What other types of research exist?

Promising novel alternatives to Mechanical Coring with Skin Closure for wrinkles include: 1) Microneedling, which uses fine needles to create micro-injuries that stimulate collagen production. 2) Fractional Laser Resurfacing, which targets small areas of the skin to promote collagen remodeling. 3) Radiofrequency Microneedling, combining microneedling with radiofrequency energy to enhance skin tightening and collagen production. 4) Injectable Fillers, such as hyaluronic acid, which can provide immediate volume and stimulate collagen over time. 5) Platelet-Rich Plasma (PRP) Therapy, which uses the patient's own blood components to promote healing and collagen production.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

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.

0 / 8Eligibility criteria met

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.