PMID- 20969657 OWN - NLM STAT- MEDLINE DCOM- 20101130 LR - 20101025 IS - 1524-4725 (Electronic) IS - 1076-0512 (Linking) VI - 36 Suppl 3 DP - 2010 Nov TI - Improvement in nasolabial folds with a hyaluronic acid filler using a cohesive polydensified matrix technology: results from an 18-month open-label extension trial. PG - 1800-8 LID - 10.1111/j.1524-4725.2010.01735.x [doi] AB - BACKGROUND: Repeat treatments of nonpermanent dermal fillers are used in the long-term treatment of wrinkles and folds and to volumize. OBJECTIVE To determine the safety and effectiveness of a nonanimal-sourced hyaluronic acid (HA) (which uses a cohesive polydensified matrix (CPM) technology [CPMHA]) for the treatment of nasolabial folds (NLFs) during an 18-month open-label extension trial. METHODS AND MATERIALS: Ninety-five of 118 subjects continued with this optional open-label extension of a split-face, double-blind trial. All subjects received CPMHA in both NLFs at 24 weeks after treatment in this study and were assessed at weeks 32, 48, 72, and 96. Touch-ups were allowed for optimal correction. Safety was assessed according to reported adverse events (AEs) and serum antibody measurement. RESULTS: At all four post-week 24 time points, the severity of the NLFs showed a decrease from baseline on the Wrinkle Severity Rating Scale. The effects persisted in the majority ( approximately 80%) of subjects without repeat treatment for at least one interval of 48 weeks. The study filler was well tolerated, with only one related AE (injection site bruising) reported. Little potential for immunogenic reactions was identified. CONCLUSION: This CPMHA is a well-tolerated and effective treatment for at least 48 weeks in the majority of subjects for the correction of moderate to severe NLFs with repeat injections given over an 18-month period. CI - (c) 2010 by the American Society for Dermatologic Surgery, Inc. FAU - Narins, Rhoda S AU - Narins RS AD - Dermatology Surgery and Laser Center, White Plains, New York 10604, USA. rsnmd@worldnet.att.net FAU - Coleman, William P 3rd AU - Coleman WP 3rd FAU - Donofrio, Lisa M AU - Donofrio LM FAU - Jones, Derek H AU - Jones DH FAU - Maas, Corey AU - Maas C FAU - Monheit, Gary AU - Monheit G FAU - Kaur, Mandeep AU - Kaur M FAU - Grundy, Starr L AU - Grundy SL FAU - Pappert, Eric J AU - Pappert EJ FAU - Hardas, Bhushan AU - Hardas B LA - eng PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - Dermatol Surg JT - Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.] JID - 9504371 RN - 0 (Viscosupplements) RN - 9004-61-9 (Hyaluronic Acid) SB - IM MH - Adult MH - Aged MH - *Cosmetic Techniques MH - Double-Blind Method MH - Face MH - Female MH - Follow-Up Studies MH - Humans MH - Hyaluronic Acid/*administration & dosage MH - Injections, Intradermal/methods MH - Male MH - Middle Aged MH - Patient Satisfaction MH - Rhytidoplasty/*methods MH - *Skin Aging MH - Time Factors MH - Treatment Outcome MH - Viscosupplements/*administration & dosage EDAT- 2010/11/05 06:00 MHDA- 2010/12/14 06:00 CRDT- 2010/10/26 06:00 PHST- 2010/10/26 06:00 [entrez] PHST- 2010/11/05 06:00 [pubmed] PHST- 2010/12/14 06:00 [medline] AID - 10.1111/j.1524-4725.2010.01735.x [doi] PST - ppublish SO - Dermatol Surg. 2010 Nov;36 Suppl 3:1800-8. doi: 10.1111/j.1524-4725.2010.01735.x.