Evaluation of Safety and Efficacy of Micro-coring Device for Treatment of Facial Wrinkles and Skin Laxity (AIS)

This is an interventional treatment trial for Wrinkle focused on measuring skin rejuvenation, wrinkle removal, skin laxity reduction Read More

Inclusion Criteria:

• Fitzpatrick Skin Type 1, 2, or 3 as assessed by Investigator

• One or more of the following conditions assessed by Investigator using provided Severity Scales:

  • Nasolabial fold severity at rest ≥2 and ≤4;
  • Marionette line prominence at rest ≥2 and ≤4;
  • Oral commissure drooping at rest ≥2 and ≤4;
  • Jawline sagging at rest ≥2 and ≤4 .
  • Moderate-to-Severe wrinkles at rest at least in one of the following areas - the upper lip, chin and cheeks.

Exclusion Criteria:

• Lesions suspicious for any malignancy or the presence of actinic keratosis, melasma, vitiligo, cutaneous papules/nodules or active inflammatory lesions in the areas to be treated
• History of keloid formation or hypertrophic scarring
• History of trauma or surgery to the treatment areas in the past 6 months
• Scar present in the areas to be treated
• Silicone or synthetic material injections in the areas to be treated
• Injection of FDA-approved dermal fillers in the past two years
• Injection of fat in the past year
• History of treatment with dermabrasion, ablative laser, or radiofrequency in the past year
• History of treatment with non-ablative laser in the past 6 months
• History of treatment with botulinum toxin injections in the areas to be treated within the prior 6 months
• Active smokers (0.5 pack/day) or having quit within 3 months prior to treatment
• Active, chronic, or recurrent infection
• History of compromised immune system or currently being treated with immunosuppressive agents
• History of sensitivity to analgesic agents, Aquaphor®, topical or local anesthetics (e.g., lidocaine, benzocaine, procaine) or chlorhexidine, povidone-iodine or epinephrine
• Excessive sun exposure and use of tanning beds or tanning creams within 30 days prior to treatment
• Treatment with aspirin or other blood thinning agents within 14 days prior to treatment
• History or presence of any clinically significant bleeding disorder
• Co-morbid condition that in the Investigator's opinion could limit ability to participate in the study or to comply with follow-up requirements
• History of drug and/or alcohol abuse
• Any issue that, at the discretion of the Investigator, would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or give informed consent
• Treatment with an investigational device or agent within 30 days before treatment or during the study period