RECRUITING

Robotic Mechanical Coring for the Treatment of Moderate to Severe Facial Wrinkles

Conditions

Wrinkle Wrinkles Mechanical Coring Robotic Coring Skin Coring Rhytides

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Clinical Evaluation of the Safety and Efficacy of Aime Robotic Mechanical Coring Device for the Treatment of Moderate to Severe Facial Wrinkles

Quick Facts

Study Start:2022-03-22

Study Completion:2025-08-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05091788

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Matthew Gronski, PhD

CONTACT

888-907-0115

mgronski@venusconcept.com

Principal Investigator

Matthew Gronski, PhD

STUDY_DIRECTOR

Venus Concept

Study Locations (Sites)

DeNova Research

Chicago, Illinois, 60611

United States

Dermatology, Laser & Vein Specialists of the Carolinas, PLLC

Charlotte, North Carolina, 28207

United States

Collaborators and Investigators

Sponsor: Venus Concept

Matthew Gronski, PhD, STUDY_DIRECTOR, Venus Concept

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-22

Study Completion Date2025-08-15

Study Record Updates

Study Start Date2022-03-22

Study Completion Date2025-08-15

Terms related to this study

Keywords Provided by Researchers

Wrinkles
Mechanical Coring
Robotic Coring
Skin Coring
Rhytides

Additional Relevant MeSH Terms

Wrinkle