PMID- 33065955
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20201019
IS  - 1524-4725 (Electronic)
IS  - 1076-0512 (Linking)
VI  - 43 Suppl 3
DP  - 2017 Dec
TI  - Safety of IncobotulinumtoxinA in the Treatment of Facial Lines: Results From a 
      Pooled Analysis of Randomized, Prospective, Controlled Clinical Studies.
PG  - S293-S303
LID - 10.1097/DSS.0000000000001409 [doi]
AB  - BACKGROUND: The safety and efficacy of incobotulinumtoxinA in aesthetics has been 
      established in multiple studies. Although individual studies have been reported, 
      a combined assessment of incobotulinumtoxinA safety across studies is not 
      available. OBJECTIVE: To assess the frequency of adverse events (AEs) across 
      prospective incobotulinumtoxinA studies in aesthetics. MATERIALS AND METHODS: 
      Safety data were assessed from 9 placebo-controlled or active-controlled 
      single-dose studies on glabellar frown lines (GFL), crow's feet (CF), and upper 
      facial lines (UFL). Analyses by treatment cycle included 4 repeat-dose studies on 
      GFL and UFL. RESULTS: One thousand three hundred seventy-seven subjects received 
      incobotulinumtoxinA (GFL, n = 1,189; CF, n = 83; UFL, n = 105) in single-dose 
      studies (placebo-controlled studies: incobotulinumtoxinA, n = 866; placebo, n = 
      395). Over 1,000 subjects received incobotulinumtoxinA in repeat-dose studies 
      (GFL, n = 880; UFL, n = 290). In placebo-controlled single-dose studies, 
      incidences of treatment-related AEs ranged from 5.4% (GFL) to 22.9% (UFL). The 
      most frequent treatment-related AE in single-dose studies was headache (GFL, 
      4.8%; UFL, 11.4%). In repeat-dose studies, incidence of AEs was highest during 
      cycle 1 (GFL, 8.9%; UFL, 17.2%) and decreased across treatment cycles. No serious 
      treatment-related AEs were observed. CONCLUSION: Results confirm the favorable 
      safety and tolerability of incobotulinumtoxinA. The frequency of 
      treatment-related AEs was low and may decrease with subsequent treatments.
FAU - Coleman, William P 3rd
AU  - Coleman WP 3rd
AD  - *Coleman Cosmetic Dermatologic Surgery Center, Metairie, Louisiana; daggerRosenpark 
      Klinik, Darmstadt, Germany; double daggerMerz Pharmaceuticals GmbH, Frankfurt am Main, 
      Germany;  section signMerz North America, Inc., Raleigh, North Carolina.
FAU - Sattler, Gerhard
AU  - Sattler G
FAU - Weissenberger, Petra
AU  - Weissenberger P
FAU - Hast, Michael A
AU  - Hast MA
FAU - Hanschmann, Angelika
AU  - Hanschmann A
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Dermatol Surg
JT  - Dermatologic surgery : official publication for American Society for Dermatologic 
      Surgery [et al.]
JID - 9504371
SB  - IM
EDAT- 2017/12/01 00:00
MHDA- 2017/12/01 00:01
CRDT- 2020/10/17 01:02
PHST- 2020/10/17 01:02 [entrez]
PHST- 2017/12/01 00:00 [pubmed]
PHST- 2017/12/01 00:01 [medline]
AID - 00042728-201712003-00007 [pii]
AID - 10.1097/DSS.0000000000001409 [doi]
PST - ppublish
SO  - Dermatol Surg. 2017 Dec;43 Suppl 3:S293-S303. doi: 10.1097/DSS.0000000000001409.