Clinical trial NCT05091788: Robotic Mechanical Coring for the Treatment of Moderate to Severe Facial Wrinkles
Official title: Clinical Evaluation of the Safety and Efficacy of Aime Robotic Mechanical Coring Device for the Treatment of Moderate to Severe Facial Wrinkles
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Wrinkle
Keywords: Wrinkles
Mechanical Coring
Robotic Coring
Skin Coring
Rhytides
Lead sponsor: Venus Concept
Sponsor class: INDUSTRY
First posted: 2021-10-25
Enrollment: 70
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

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.

Primary outcomes:
measure: Proportion of correct identification of photograph sets from baseline and Day 120
timeFrame: 4 Months
Secondary outcomes:
measure: Assess aesthetic improvement using Global Aesthetic Improvement Scale
timeFrame: 4 Months
measure: Assess subject satisfaction post-treatment using Subject Satisfaction Scale
timeFrame: 4 Months
Other outcomes:
measure: Assess subject's assessment of discomfort and pain using Visual Analogue Scale
timeFrame: 1 day
measure: Assess safety profile by recording adverse events
timeFrame: 4 Months
Locations:
city: Chicago
country: United States
facility: DeNova Research
state: Illinois
city: Charlotte
country: United States
facility: Dermatology, Laser & Vein Specialists of the Carolinas, PLLC
state: North Carolina
Study officials:
affiliation: Venus Concept
name: Matthew Gronski, PhD
role: STUDY_DIRECTOR
References: