Last updated: January 24, 2024
Sponsor: Venus Concept
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
Venus Aime
Clinical Study ID
NCT05091788
AI0321
Ages 22-75 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female subjects between 22 and 75 years of age.
- Able to read, understand and voluntarily provide written Informed Consent.
- Able and willing to comply with the treatment/follow-up schedule and requirements.
- Women of childbearing age are required to be using a reliable method of birth controlat least 3 months prior to study enrollment and for the duration of the study and havea negative Urine Pregnancy test at baseline.
- Fitzpatrick skin type I to IV.
- Cheek areas are at least a score of 3 using the Lemperle Wrinkle Scale as judged bythe Investigator.
Exclusion
Exclusion Criteria:
- Previous aesthetic (device and/or surgical) skin treatment (injection of dermalfillers, fat, or botulinum toxin), in the treated areas in the last 6 months.
- Silicone, Tattoos, body jewelry, that cannot be removed for the duration of treatmentand/or any other synthetic material in the treatment area.
- Any type of scar in the treatment area
- Excessive sun exposure and use of tanning beds or tanning creams within 30 days toprior to treatment.
- History of keloid formation or hypertrophic scarring.
- Active smoker or having quit smoking in the last 3 months.
- Active, chronic, or recurrent infection including Herpes simplex virus (HSV) infectionor history of HSV in the last 6 months.
- Compromised immune and/or healing system (e.g., poorly controlled diabetes, collagenvascular disease or autoimmune diseases such as scleroderma, morphea, etc.).
- Hypersensitivity/allergy to analgesic agents, Betadine, tumescent, Tegaderm ortensioning tape that will be used in the study.
- Co-morbid condition that could limit the ability of the subject to participate in thestudy or to comply with follow-up requirements.
- Pregnant, planning pregnancy during the trial course or breastfeeding.
- History of bleeding disorder or taking medication that can potentially increasebleeding including anticoagulation.
- Carcinoma, melanoma, or any other cutaneous cancerous condition in the last 6 months.
- Non-cancerous lesions (e.g. actinic keratosis, vitiligo, cutaneous papules, nodules,active inflammatory lesions) in the region to be treated.
- Currently or in the last 1-month part of another clinical study of an investigationaldrug and/or experimental medical device.
- Any medical condition that, at the discretion of the investigator, would hamper theimpact or the healing process and contra-indicate the subject's participation.
Study Design
Total Participants: 70
Treatment Group(s): 1
Primary Treatment: Venus Aime
Phase:
Study Start date:
March 22, 2022
Estimated Completion Date:
August 15, 2025
Study Description
Connect with a study center
Dr. Brian Kinney
Beverly Hills, California 90212
United StatesSite Not Available
DeNova Research
Chicago, Illinois 60611
United StatesTerminated
Dermatology, Laser & Vein Specialists of the Carolinas, PLLC
Charlotte, North Carolina 28207
United StatesActive - Recruiting
Menter Dermatology Research Institute
Dallas, Texas 75246
United StatesSite Not Available
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