Micro-Coring® for the Treatment of Skin Laxity of the Knees

Inclusion criteria

• Male or female age 22 to 70
• With lax skin over one or both knees, physician discretion
• Able to provide written informed consent, understand and willing to comply with all study related procedures and follow-up visits
• Fitzpatrick Skin Type I to VI as evaluated by the Investigator

Exclusion criteria

• Pregnant women or nursing mothers
• Body mass index > 30 · Patients with dermatosis, open wounds, sores, or irritated skin in the treatment area
• Patients with allergy to stainless steel or to topical, oral, or injected medications or preparations that may be used during the procedure, such as petrolatum, lidocaine, bupivacaine, chlorhexidine, or povidone-iodine
• Patients with a history or presence of any clinically significant bleeding disorder
• Patients with dermatological or autoimmune conditions that may affect the treatment outcome; these may include, but are not limited to: actinic keratosis, raised nevi, rosacea, melasma, active acne, cutaneous papules/nodules, active inflammatory lesions, dermatitis, psoriasis, cellulitis, urticarial folliculitis, acute inflammatory phase of scleroderma, rheumatoid arthritis, eczema, psoriasis, allergic dermatitis, collagen disorders, or lupus
• Patients with systemic infections or acute local skin infections (as Hepatitis disorders type A, B, C, D, E or F or HIV infection)
• Patients who are on a high dose of anti-coagulants or blood-thinning substances, e.g., aspirin > 150 mg/day, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin, heparin, acetylsalicylic acid during the previous fourteen (14) days
• Patients who are on courses of chemotherapy, high-dose corticosteroid use, or radiation in the treatment area
• Patients with have undergone surgery of the treatment area within last twelve (12) months, or have any scars less than twelve (12) months old in the treatment area
• Patients who have undergone injections of dermal fillers, fat, or botulinum toxin, as well as any minimally invasive/invasive skin treatment in the treatment area during the previous six (6) months
• During the study time frame, unwilling to refrain from receiving these following aesthetic treatments within the same body region: toxin, filler, any skin resurfacing (laser, RF, ultrasound, microneedling, etc.);
• Are currently enrolled in, or have overlapping participation in, another clinical trial outside of Cytrellis that includes treatment to the study area.
• Unwilling to have photography taken for the study purpose
• Any physical or psychological factors, in the judgment of the study investigator, may prevent subject from adhering to the study requirement correctly.
• History of keloid formation or hypertrophic scarring
• Excessive sun exposure and use of tanning beds or tanning creams within 30 days prior to treatment and for the duration of the study