PMID- 33944905
OWN - NLM
STAT- MEDLINE
DCOM- 20211124
LR  - 20211124
IS  - 1527-330X (Electronic)
IS  - 1090-820X (Print)
IS  - 1090-820X (Linking)
VI  - 41
IP  - 12
DP  - 2021 Nov 12
TI  - The First of Two One-Year, Multicenter, Open-Label, Repeat-Dose, Phase II Safety 
      Studies of PrabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar 
      Lines in Adult Patients.
PG  - 1409-1422
LID - 10.1093/asj/sjaa383 [doi]
AB  - BACKGROUND: PrabotulinumtoxinA is a 900-kDa botulinum toxin type A produced by 
      Clostridium botulinum. OBJECTIVES: The authors sought to investigate the safety 
      of prabotulinumtoxinA for treatment of glabellar lines. METHODS: This was a 
      multicenter, open-label, repeat-dose, 1-year phase II safety study. Adults with 
      moderate to severe glabellar lines at maximum frown, as assessed by the 
      investigator on the validated 4-point photonumeric Glabellar Line Scale (0 = no 
      lines, 1 = mild, 2 = moderate, 3 = severe), were enrolled. On day 0, patients 
      received an initial treatment of 20 U prabotulinumtoxinA (4 U/0.1 mL freeze-dried 
      formulation injected into 5 target glabellar sites). On and after day 90, 
      patients received a repeat treatment (RT) if their Glabellar Line Scale score was 
      >/=2 at maximum frown by investigator assessment. Safety was evaluated throughout 
      the study. RESULTS: The 352 study patients received a median total dose of 60 U, 
      that is, 3 treatments per year. Fifty-one patients (14.5%) experienced adverse 
      events (AEs) assessed as possibly study drug related; 11.1% experienced study 
      drug-related AEs after the initial treatment. With each RT, progressively lower 
      percentages of patients experienced study drug-related AEs. Six patients (1.7%) 
      experienced study drug-related AEs of special interest: 3 eyelid ptosis (0.9%), 2 
      speech disorder (0.6%), and 1 blepharospasm (0.3%). Seven patients (2.0%) 
      experienced serious AEs; none were study drug related. Of the 2393 samples 
      tested, 2 patients (0.6%) tested positive for antibotulinum toxin antibodies at a 
      single postbaseline visit. CONCLUSIONS: The safety of RTs of 20 U of 
      prabotulinumtoxinA for moderate to severe glabellar lines was first established 
      in this early phase II study based on a broad range of outcomes.
CI  - (c) 2021 The Aesthetic Society.
FAU - Kaufman-Janette, Joely
AU  - Kaufman-Janette J
FAU - Avelar, Rui L
AU  - Avelar RL
FAU - Biesman, Brian S
AU  - Biesman BS
FAU - Draelos, Zoe Diana
AU  - Draelos ZD
FAU - Gross, John E
AU  - Gross JE
FAU - Jones, Derek H
AU  - Jones DH
FAU - Lupo, Mary P
AU  - Lupo MP
FAU - Maas, Corey S
AU  - Maas CS
FAU - Schlessinger, Joel
AU  - Schlessinger J
FAU - Shamban, Ava Teresa
AU  - Shamban AT
FAU - Sundaram, Hema
AU  - Sundaram H
FAU - Weinkle, Susan H
AU  - Weinkle SH
FAU - Young, Vernon L
AU  - Young VL
LA  - eng
GR  - EV-004 study, Evolus, Inc/
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PL  - England
TA  - Aesthet Surg J
JT  - Aesthetic surgery journal
JID - 9707469
RN  - 0 (Neuromuscular Agents)
RN  - EC 3.4.24.69 (Botulinum Toxins, Type A)
SB  - IM
EIN - Aesthet Surg J. 2021 Jul 26;:. PMID: 34309676
MH  - Adult
MH  - *Botulinum Toxins, Type A/adverse effects
MH  - Double-Blind Method
MH  - Forehead
MH  - Humans
MH  - *Neuromuscular Agents
MH  - *Skin Aging
MH  - Treatment Outcome
PMC - PMC8598194
EDAT- 2021/05/05 06:00
MHDA- 2021/11/25 06:00
PMCR- 2021/05/04
CRDT- 2021/05/04 12:34
PHST- 2021/05/05 06:00 [pubmed]
PHST- 2021/11/25 06:00 [medline]
PHST- 2021/05/04 12:34 [entrez]
PHST- 2021/05/04 00:00 [pmc-release]
AID - 6263932 [pii]
AID - sjaa383 [pii]
AID - 10.1093/asj/sjaa383 [doi]
PST - ppublish
SO  - Aesthet Surg J. 2021 Nov 12;41(12):1409-1422. doi: 10.1093/asj/sjaa383.