BACKGROUND: Characteristics of the aging face include soft tissue atrophy, loss of skin elasticity resulting in excess facial skin, and gravitational descent or ptosis of facial soft tissues. Poly-L-lactic acid (PLLA) is a synthetic biodegradable polymer that provides soft tissue augmentation through stimulation of an inflammatory tissue response with subsequent collagen deposition. OBJECTIVE: The authors discuss the special considerations inherent in facial aging, describe the mechanism of action and indications for a new PLLA filler under consideration for Food and Drug Administration (FDA) approval (Sculptra Aesthetic, sanofi-aventis US, Bridgewater, New Jersey), and detail the results of a two-year off-label pilot study with the product. METHODS: The senior author (LAC) treated 106 patients with PLLA in an off-label indication, as part of a pilot study while Sculptra Aesthetic was being evaluated for FDA approval for cosmetic indications. All patients were followed up for two years to help develop a protocol for injection technique. RESULTS: The age range of patients in this series was 40 to 78 years. Three patients were male and 103 were female. Patients received an average injection of 1.6 vials per session, over an average of 2.3 sessions, to achieve volume restoration in the tear trough, midface, malar region, nasolabial folds, prejowl area, mandibular border, and mandibular angle. The authors we achieved 100% follow-up with 99.1% patient satisfaction. The rate of nodule formation was 4.7% at a minimum follow-up of two years. CONCLUSIONS: Because of its unique mechanism of action, PLLA for nonsurgical facial rejuvenation requires meticulous injection technique with special considerations for optimizing outcomes and minimizing adverse events.
BACKGROUND: Characteristics of the aging face include soft tissue atrophy, loss of skin elasticity resulting in excess facial skin, and gravitational descent or ptosis of facial soft tissues. Poly-L-lactic acid (PLLA) is a synthetic biodegradable polymer that provides soft tissue augmentation through stimulation of an inflammatory tissue response with subsequent collagen deposition. OBJECTIVE: The authors discuss the special considerations inherent in facial aging, describe the mechanism of action and indications for a new PLLA filler under consideration for Food and Drug Administration (FDA) approval (Sculptra Aesthetic, sanofi-aventis US, Bridgewater, New Jersey), and detail the results of a two-year off-label pilot study with the product. METHODS: The senior author (LAC) treated 106 patients with PLLA in an off-label indication, as part of a pilot study while Sculptra Aesthetic was being evaluated for FDA approval for cosmetic indications. All patients were followed up for two years to help develop a protocol for injection technique. RESULTS: The age range of patients in this series was 40 to 78 years. Three patients were male and 103 were female. Patients received an average injection of 1.6 vials per session, over an average of 2.3 sessions, to achieve volume restoration in the tear trough, midface, malar region, nasolabial folds, prejowl area, mandibular border, and mandibular angle. The authors we achieved 100% follow-up with 99.1% patient satisfaction. The rate of nodule formation was 4.7% at a minimum follow-up of two years. CONCLUSIONS: Because of its unique mechanism of action, PLLA for nonsurgical facial rejuvenation requires meticulous injection technique with special considerations for optimizing outcomes and minimizing adverse events.
Authors: Martin Parizek; Nikola Slepickova Kasalkova; Lucie Bacakova; Zdenek Svindrych; Petr Slepicka; Marketa Bacakova; Vera Lisa; Vaclav Svorcik Journal: Biomed Res Int Date: 2013-03-24 Impact factor: 3.411