Treatment of Perioral Wrinkles Using Topical Poly-L-lactic Acid and Microneedling Device

Inclusion Criteria:

• Males and non-pregnant, non-lactating females 40-70 years of age

• Fitzpatrick Skin Type I-IV

• Wrinkle severity graded by the investigator (1-3 on Lemperle scale)

• Able to provide written informed consent, understand and be willing to comply withall study related procedures and follow-up visits

• Signed informed consent obtained before any study-specific procedure is performed.

Exclusion Criteria:

• Lesions suspicious for any malignancy, actinic keratosis, melasma, vitiligo,cutaneous papules/nodules or active inflammatory lesions in the area to be treated

• Tenderness in the treatment rea

• History of keloid formation or hypertrophic scarring

• History of trauma or surgery to the treatment area

• Scar present in the areas to be treated

• Silicone or synthetic material injections in the areas to be treated

• Injection of fat, collagen, hyaluronic acid or other dermal fillers in the areas tobe treated within the previous 12 months

• History of treatment with dermabrasion or laser in the areas to be treated withinthe previous 12 months

• History of treatment with botulinum toxin injections in the areas to be treatedwithin the prior 6 months

• Active smokers (0.5 pack/day) or having quit within 3 months prior treatment

• Active, chronic, or recurrent infection

• History of compromised immune system or currently being treated withimmunosuppressive agents

• History of sensitivity to analgesic agents, Aquaphor, topical or local anesthetics

• Excessive sun exposure and use of tanning beds or tanning creams within 30 daysprior to treatment

• Treatment with fish oil within 14 days prior to treatment

• Treatment with aspirin or other blood thinning agents within 14 days prior totreatment

• History or presence of any clinically significant bleeding disorder

• Co-morbid condition that in the Investigator's opinion could limit ability toparticipate 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 withassessment of safety or efficacy or compromise the subject's ability to safelyundergo study procedures or give informed consent

• Treatment with an investigational device or agent within 30 days before treatment orduring the study period