PMID- 22621180 OWN - NLM STAT- MEDLINE DCOM- 20121119 LR - 20181201 IS - 1524-4725 (Electronic) IS - 1076-0512 (Linking) VI - 38 IP - 9 DP - 2012 Sep TI - OnabotulinumtoxinA dose-ranging study for hyperdynamic perioral lines. PG - 1497-505 LID - 10.1111/j.1524-4725.2012.02456.x [doi] AB - BACKGROUND: Few dosing data on onabotulinumtoxinA to treat hyperdynamic perioral lines (POLs) are available. Studying onabotulinumtoxinA in controlled settings is beneficial to treating a hyperfunctional orbicularis oris. OBJECTIVE: To compare the dose-response relationship of two doses of onabotulinumtoxinA in hyperdynamic POLs. METHODS: Female subjects (N = 60) received injections of onabotulinumtoxinA at four sites totaling 7.5 U or 12.0 U. Subjects returned at weeks 2, 4, 8, 12, 16, and 20. POL severity and total lip satisfaction (TLS) were assessed at all visits. RESULTS: Investigator-assessed POL severity was reduced through week 20 for 12.0 U (p < .01). POL reduction for 7.5 U persisted until week 16 (p < .05). Responder rates did not differ until week 12 (12.0 U, 77%; 7.5 U, 36%; p = .003). Subject-assessed TLS was improved (p < .05) at all time points for both groups except at week 20 (12.0 U; p = .06). Most adverse events (AEs) were mild to moderate in severity and typical for onabotulinumtoxinA treatment in the lips, and the incidence was dose-dependent. CONCLUSION: OnabotulinumtoxinA provides significant reductions in POL severity and high levels of subject satisfaction. Lack of dose response and fewer AEs suggest that treatment of hyperdynamic POLs with 7.5 U appears adequate for up to 16 weeks. CI - (c) 2012 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc. FAU - Cohen, Joel L AU - Cohen JL AD - AboutSkin Dermatology and DermSurgery, Englewood, CO 80113, USA. jcohenderm@yahoo.com FAU - Dayan, Steven H AU - Dayan SH FAU - Cox, Sue Ellen AU - Cox SE FAU - Yalamanchili, Ramana AU - Yalamanchili R FAU - Tardie, Greg AU - Tardie G LA - eng PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20120523 PL - United States TA - Dermatol Surg JT - Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.] JID - 9504371 RN - 0 (Neuromuscular Agents) RN - EC 3.4.24.69 (Botulinum Toxins, Type A) SB - IM MH - Adult MH - Botulinum Toxins, Type A/*administration & dosage/adverse effects MH - Chi-Square Distribution MH - Dose-Response Relationship, Drug MH - Double-Blind Method MH - Female MH - Humans MH - Intention to Treat Analysis MH - Lip MH - Middle Aged MH - Neuromuscular Agents/*administration & dosage/adverse effects MH - Patient Satisfaction MH - Photography MH - Skin Aging/*drug effects MH - Statistics, Nonparametric MH - Time Factors EDAT- 2012/05/25 06:00 MHDA- 2012/12/10 06:00 CRDT- 2012/05/25 06:00 PHST- 2012/05/25 06:00 [entrez] PHST- 2012/05/25 06:00 [pubmed] PHST- 2012/12/10 06:00 [medline] AID - 10.1111/j.1524-4725.2012.02456.x [doi] PST - ppublish SO - Dermatol Surg. 2012 Sep;38(9):1497-505. doi: 10.1111/j.1524-4725.2012.02456.x. Epub 2012 May 23.