dermal microcoring device (Ellacor)

Indications

• reportedly effective for treatment of facial wrinkles

* for use by medical professionals for the treatment of moderate & severe wrinkles in the mid & lower face in adults >=22 years of age with Fitzpatrick skin types 1-4

Contraindications

• skin neoplasms, keloids or predisposition to keloids, solar keratosis, warts, or birthmarks), area within the bony orbital rim, mucous membranes, areas where silicone or synthetic material is implanted

• pregnant or nursing mothers
• open wounds, sores, or irritated skin in the treatment area
• allergy to stainless steel or allergy to topical, oral, or injected medications or preparations that may be used during the procedure, including petrolatum, lidocaine, bupivacaine, chlorhexidine, or povidone-iodine
• history or presence of any clinically significant bleeding disorder
• dermatological or autoimmune conditions that may affect the treatment outcome
  • actinic keratosis, raised nevi, rosacea, melasma, active acne, cutaneous papules, skin nodules, active inflammatory lesions, dermatitis, psoriasis, cellulitis, urticarial folliculitis, acute inflammatory phase of scleroderma, rheumatoid arthritis, eczema, psoriasis, allergic dermatitis, collagen disorders, lupus
• systemic infections or acute local skin infections such as viral hepatitis or HIV infection
• high dose of anticoagulants or antiplatelet agents within 14) days
• chemotherapy, high-dose corticosteroid use, or radiation in the treatment area
• plastic surgery of the face within the last 12 months
• facial surgical scars <12 months old
• injections of dermal fillers, fat, or botulinum toxin within 6 months
• scars < 6 months old in the treatment area

Precautions

• history of hyperpigmentation
• recent exposure to sun or tanning beds with red, peeling, or swollen skin
• active, chronic, or recurrent infection including bacterial infections or fungal infections
• history of active herpes simplex infection in the treatment area
• use of topical or oral medications that may change skin integrity or prolong healing
• over the counter & herbal supplements that may increase the risk of bleeding or prolong healing
  • gingko biloba, garlic, ginseng, dong quai, fever few, fish oil
• recent trauma or surgery to the treatment area

Adverse effects

• erythema, edema, bruising, burning, dryness, roughness, tightness/pulling of skin, crusting, pain/discomfort, tenderness, tingling, bleeding, numbness, skin peeling, circular marks on skin.

• less common: itching, hyperpigmentation, hypopigmentation, hematoma, infection, scarring, skin irregularities, skin necrosis, uneven appearance of the treated regions, anesthesia-related complications

Procedure

• Ellacor uses hollow needles to remove micro-cores of skin, resulting in an improved appearance of moderate & severe wrinkles in the mid & lower face
• the internal diameter of each needle is < 0.5 mm (below threshold for scarring)
• device precisely moves needles across treatment area, removing microcores of skin
• a 10 mm2 area can be treated in < 3 seconds
• a procedure is generally completed in < 30 minutes

More general terms

• device (medical device)