Overview
Study evaluating the efficacy of a micro coring device for the treatment of moderate to severe check wrinkles
Description
Up to 35 subjects who meet the inclusion/exclusion criteria will be treated. All subjects will be monitored for a period of 90 days post treatment.
Study results will be assessed with the following:
- Lemperle Scale
- Investigator GAIS Scale
- Subject Satisfaction Scale
Eligibility
Inclusion Criteria:
- Males and females 40-70 years of age
- Fitzpatrick Skin Type I to IV as judged by the Investigator
- Cheek areas are at least a score of 3 using the Lemperle Wrinkle Assessment Scale as judged by the Investigator
- Able to provide written informed consent, understand and willing to comply with all study related procedures and follow-up visits.
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 injections in the areas to be treated
- Injection of dermal fillers, fat or botulinum toxin, as well as any minimally invasive/invasive medical device for skin treatment, in the study treatment areas, within the past 6 months (i.e., dermabrasion, laser, RF devices)
- 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
- Any issue that, at the discretion of the Investigator, would interfere with assessment of safety or efficacy or compromise the subject's ability to participate in the study
- Treatment with an investigational device or agent within 30 days before treatment or during the study period
