PMID- 25828037 OWN - NLM STAT- MEDLINE DCOM- 20150605 LR - 20150401 IS - 1524-4725 (Electronic) IS - 1076-0512 (Linking) VI - 41 Suppl 1 DP - 2015 Apr TI - A randomized, evaluator-blinded, controlled study of effectiveness and safety of small particle hyaluronic acid plus lidocaine for lip augmentation and perioral rhytides. PG - S127-36 LID - 10.1097/DSS.0000000000000199 [doi] AB - OBJECTIVE: To compare the safety and effectiveness of small particle hyaluronic acid plus lidocaine (SPHAL) versus no treatment for lip augmentation and perioral rhytides. METHODS AND MATERIALS: Adults scoring 1 (very thin) to 2 (thin) on the Medicis Lip Fullness Scale (MLFS) for upper and lower lips were randomized (3:1) to SPHAL or no treatment. Treatment success was an MLFS increase >/=1 point at Week 8. Secondary end points (MLFS score, independent photographic review, Global Aesthetic Improvement Scale, Wrinkle Assessment Scale for Upper Lip Lines) and safety were assessed throughout. RESULTS: Statistically significantly more patients were treatment successes with SPHAL (upper lip [80.2% vs 11.9%], lower lip [84.2% vs 18.4%], and upper and lower lips combined [76.1% vs 11.6%]), compared with no treatment (p <.001, all outcomes). Patients treated for both lip augmentation and perioral rhytides were rated as having an aesthetically meaningful improvement in perioral rhytides (p <.001). Most common treatment-emergent adverse events (AEs) included lip bruising, swelling, and pain and were mostly mild and transient in nature, without anticipated device AEs. CONCLUSION: Small particle hyaluronic acid plus lidocaine was effective and well tolerated and significantly more effective when both lips and perioral rhytides were treated, with improvement evident up to 6 months after treatment. FAU - Beer, Kenneth AU - Beer K AD - *Department of Dermatology, University of Pennsylvania, Philadelphia, Pennsylvania; daggerDepartment of Dermatology, University of California, San Francisco, California; double daggerDepartment of Dermatology, Yale University School of Medicine, New Haven, Connecticut; section signDepartment of Dermatology, Geffen School of Medicine, University of California Los Angeles, Los Angeles, California; ||Valeant Aesthetics, a Division of Valeant Pharmaceuticals North America LLC, Bridgewater, New Jersey; paragraph signInergy Limited, Lindfield, United Kingdom. FAU - Glogau, Richard G AU - Glogau RG FAU - Dover, Jeffrey S AU - Dover JS FAU - Shamban, Ava AU - Shamban A FAU - Handiwala, Lata AU - Handiwala L FAU - Olin, Jason T AU - Olin JT FAU - Bulley, Brian AU - Bulley B LA - eng PT - Journal Article PT - Randomized Controlled Trial PL - United States TA - Dermatol Surg JT - Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.] JID - 9504371 RN - 0 (Anesthetics, Local) RN - 0 (Gels) RN - 9004-61-9 (Hyaluronic Acid) RN - 98PI200987 (Lidocaine) SB - IM MH - Adolescent MH - Aged MH - Anesthetics, Local/*administration & dosage/adverse effects MH - Contusions/chemically induced MH - *Cosmetic Techniques MH - Edema/chemically induced MH - Female MH - Gels MH - Humans MH - Hyaluronic Acid/*administration & dosage/adverse effects MH - Injections, Intradermal MH - Lidocaine/*administration & dosage/adverse effects MH - *Lip MH - Male MH - Middle Aged MH - Pain/chemically induced MH - Particle Size MH - Rejuvenation MH - *Skin Aging MH - Young Adult EDAT- 2015/04/02 06:00 MHDA- 2015/06/06 06:00 CRDT- 2015/04/02 06:00 PHST- 2015/04/02 06:00 [entrez] PHST- 2015/04/02 06:00 [pubmed] PHST- 2015/06/06 06:00 [medline] AID - 00042728-201504001-00003 [pii] AID - 10.1097/DSS.0000000000000199 [doi] PST - ppublish SO - Dermatol Surg. 2015 Apr;41 Suppl 1:S127-36. doi: 10.1097/DSS.0000000000000199.