PMID- 30893159
OWN - NLM
STAT- MEDLINE
DCOM- 20200113
LR  - 20200113
IS  - 1524-4725 (Electronic)
IS  - 1076-0512 (Linking)
VI  - 45
IP  - 10
DP  - 2019 Oct
TI  - Clinical Assessment of 2 Licensed AbobotulinumtoxinA Injection Volumes for the 
      Treatment of Glabellar Lines.
PG  - 1274-1284
LID - 10.1097/DSS.0000000000001926 [doi]
AB  - BACKGROUND: Two licensed reconstitution volumes may be used to achieve the 
      recommended abobotulinumtoxinA (ABO) dose for glabellar line correction. 
      OBJECTIVE: Comparison of efficacy, safety, and subject satisfaction concerning 
      treatment of moderate to severe glabellar lines with 2 different ABO 
      reconstitution volumes. MATERIALS AND METHODS: Phase IV, prospective, randomized, 
      multicenter, subject- and evaluator-blinded study: 60 subjects received 1 ABO (50 
      units) treatment, administered as a 1.5- or 2.5-mL reconstitution. Primary 
      objective was Day 30 improvements (>/=1-point) in glabellar line severity. Onset of 
      effect, duration, subject satisfaction, and treatment-related adverse events 
      (AEs) were assessed. RESULTS: At Day 30, 90.0% and 86.7% of subjects achieved 
      >/=1-point improvements with 1.5- and 2.5-mL reconstitutions, respectively. Median 
      time to onset of effect was 48 hours after treatment. At 24 hours, 26.7% achieved 
      >/=1-point improvements with the 2.5-mL reconstitution versus 6.7% with the 1.5-mL 
      reconstitution. Maximum response was at Day 14, and >40% maintained efficacy 
      through Day 120 in each group. High subject satisfaction was sustained throughout 
      observation. Most AEs were mild. No serious AEs were reported. CONCLUSION: Both 
      ABO reconstitutions were well tolerated and effective in correcting glabellar 
      lines with no significant differences concerning efficacy or duration of effect. 
      No serious AEs were reported.
FAU - Kaufman, Joely
AU  - Kaufman J
AD  - Skin Associates of South Florida, Skin Research Institute, Coral Gables, Florida.
FAU - Cohen, Joel L
AU  - Cohen JL
AD  - Greenwood Village and Lone Tree, Colorado.
AD  - Department of Dermatology, University of California Irvine, Irvine, California.
FAU - Peredo, Marina I
AU  - Peredo MI
AD  - Skinfluence, New York, New York.
FAU - Jonas, Brandie
AU  - Jonas B
AD  - Galderma Laboratories, L.P., Fort Worth, Texas.
FAU - Down, Rebecca
AU  - Down R
AD  - Zenith Healthcare Communications, Chester, United Kingdom.
FAU - Nogueira, Alessandra
AU  - Nogueira A
AD  - Galderma Laboratories, L.P., Fort Worth, Texas.
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
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 (Acetylcholine Release Inhibitors)
RN  - EC 3.4.24.69 (Botulinum Toxins, Type A)
RN  - EC 3.4.24.69 (abobotulinumtoxinA)
SB  - IM
MH  - Acetylcholine Release Inhibitors/*administration & dosage/adverse effects
MH  - Adolescent
MH  - Adult
MH  - Botulinum Toxins, Type A/*administration & dosage/adverse effects
MH  - Cosmetic Techniques/*adverse effects
MH  - Dose-Response Relationship, Drug
MH  - Facial Muscles/drug effects
MH  - Female
MH  - Forehead
MH  - Headache/chemically induced/epidemiology
MH  - Humans
MH  - Injection Site Reaction/epidemiology
MH  - Injections, Subcutaneous
MH  - Male
MH  - Middle Aged
MH  - *Patient Satisfaction
MH  - Prospective Studies
MH  - Skin Aging/*drug effects
MH  - Time Factors
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2019/03/21 06:00
MHDA- 2020/01/14 06:00
CRDT- 2019/03/21 06:00
PHST- 2019/03/21 06:00 [pubmed]
PHST- 2020/01/14 06:00 [medline]
PHST- 2019/03/21 06:00 [entrez]
AID - 10.1097/DSS.0000000000001926 [doi]
PST - ppublish
SO  - Dermatol Surg. 2019 Oct;45(10):1274-1284. doi: 10.1097/DSS.0000000000001926.