Robotic mechanical coring to improve facial wrinkles

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 testing a new robotic treatment to see if it can safely reduce moderate to severe wrinkles on the cheeks for people who want to improve their appearance.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 22 Years to 75 Years
• Sex: All
• Sponsor: Venus Concept (Industry-sponsored)
• Locations: 2 sites (Chicago, Illinois and 1 other locations)
• Trial ID: NCT05091788 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of a robotic mechanical coring technique combined with skin closure to treat moderate to severe wrinkles on the cheeks. It involves a prospective design across up to four centers, enrolling up to 70 subjects who will undergo two treatment sessions. Participants will be monitored for their progress at multiple time points post-treatment to assess improvements in wrinkle appearance. The study aims to provide a novel approach to wrinkle treatment using advanced technology.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22 to 75 with moderate to severe cheek wrinkles and Fitzpatrick skin types I to IV.

Not a fit: Patients with recent aesthetic treatments in the target area or those with certain skin conditions or materials in the treatment area may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly enhance the appearance of facial wrinkles, providing patients with a non-invasive option for skin rejuvenation.

How similar studies have performed: While this approach is innovative, similar studies using mechanical coring techniques have shown promise in improving skin appearance, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. Male or female subjects between 22 and 75 years of age.
2. Able to read, understand and voluntarily provide written Informed Consent.
3. Able and willing to comply with the treatment/follow-up schedule and requirements.
4. 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.
5. Fitzpatrick skin type I to IV.
6. Cheek areas are at least a score of 3 using the Lemperle Wrinkle Scale as judged by the Investigator.

Exclusion Criteria:

1. 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.
2. Silicone, Tattoos, body jewelry, that cannot be removed for the duration of treatment and/or any other synthetic material in the treatment area.
3. Any type of scar in the treatment area
4. Excessive sun exposure and use of tanning beds or tanning creams within 30 days to prior to treatment.
5. History of keloid formation or hypertrophic scarring.
6. Active smoker or having quit smoking in the last 3 months.
7. Active, chronic, or recurrent infection including Herpes simplex virus (HSV) infection or history of HSV in the last 6 months.
8. Compromised immune and/or healing system (e.g., poorly controlled diabetes, collagen vascular disease or autoimmune diseases such as scleroderma, morphea, etc.).
9. Hypersensitivity/allergy to analgesic agents, Betadine, tumescent, Tegaderm or tensioning tape that will be used in the study.
10. Co-morbid condition that could limit the ability of the subject to participate in the study or to comply with follow-up requirements.
11. Pregnant, planning pregnancy during the trial course or breastfeeding.
12. History of bleeding disorder or taking medication that can potentially increase bleeding including anticoagulation.
13. Carcinoma, melanoma, or any other cutaneous cancerous condition in the last 6 months.
14. Non-cancerous lesions (e.g. actinic keratosis, vitiligo, cutaneous papules, nodules, active inflammatory lesions) in the region to be treated.
15. Currently or in the last 1-month part of another clinical study of an investigational drug and/or experimental medical device.
16. 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.

Where this trial is running

Chicago, Illinois and 1 other locations

• DeNova Research — Chicago, Illinois, United States (Terminated)
• Dermatology, Laser & Vein Specialists of the Carolinas, PLLC — Charlotte, North Carolina, United States (Recruiting)

Study contacts

• Study coordinator: Matthew Gronski, PhD

Conditions Wrinkle; Wrinkles; Mechanical Coring; Robotic Coring; Skin Coring; Rhytides