PMID- 33944913
OWN - NLM
STAT- MEDLINE
DCOM- 20211124
LR  - 20231108
IS  - 1527-330X (Electronic)
IS  - 1090-820X (Print)
IS  - 1090-820X (Linking)
VI  - 41
IP  - 12
DP  - 2021 Nov 12
TI  - The Second 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  - 1423-1438
LID - 10.1093/asj/sjaa382 [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 independently assessed by 
      both investigator and patient 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 (IT) of 20 U prabotulinumtoxinA (4 
      U/0.1 mL final vacuum-dried formulation injected into 5 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 outcomes 
      were evaluated throughout the study. RESULTS: The 570 study patients received a 
      median total dose of 60 U, that is, 3 treatments. Sixty-one patients (10.7%) 
      experienced adverse events (AEs) assessed as possibly study drug related; 6.5% 
      experienced study drug-related AEs after the IT. With each RT, progressively 
      lower percentages of patients experienced study drug-related AEs. Eight patients 
      (1.4%) experienced study drug-related AEs of special interest: 5 experienced 
      eyelid ptosis (0.9%), 3 eyebrow ptosis (0.5%), 1 blepharospasm (0.2%), and 1 
      blurred vision (0.2%). Seven patients (1.2%) experienced serious AEs, but none 
      were study drug related. A total of 4060 serum samples were tested for 
      antibotulinum toxin antibodies; no seroconversion was observed. CONCLUSIONS: The 
      safety of RTs of 20 U of prabotulinumtoxinA for moderate to severe glabellar 
      lines was confirmed in this second phase II study based on a broad range of 
      outcomes.
CI  - (c) 2021 The Aesthetic Society.
FAU - Lorenc, Z Paul
AU  - Lorenc ZP
FAU - Adelglass, Jeffrey M
AU  - Adelglass JM
FAU - Avelar, Rui L
AU  - Avelar RL
FAU - Baumann, Leslie
AU  - Baumann L
FAU - Beer, Kenneth R
AU  - Beer KR
FAU - Cohen, Joel L
AU  - Cohen JL
FAU - Cox, Sue Ellen
AU  - Cox SE
FAU - Dayan, Steven H
AU  - Dayan SH
FAU - Dover, Jeffrey S
AU  - Dover JS
FAU - Downie, Jeanine B
AU  - Downie JB
FAU - Draelos, Zoe Diana
AU  - Draelos ZD
FAU - Goldman, Mitchel P
AU  - Goldman MP
FAU - Gross, John E
AU  - Gross JE
FAU - Joseph, John H
AU  - Joseph JH
FAU - Kaufman-Janette, Joely
AU  - Kaufman-Janette J
FAU - Moy, Ronald L
AU  - Moy RL
FAU - Nestor, Mark
AU  - Nestor M
FAU - Schlessinger, Joel
AU  - Schlessinger J
FAU - Smith, Stacy R
AU  - Smith SR
FAU - Weiss, Robert A
AU  - Weiss RA
LA  - eng
GR  - EV-006 study/
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 Jun 30;:. PMID: 34189562
MH  - Adult
MH  - *Blepharoptosis
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 - PMC8598184
EDAT- 2021/05/05 06:00
MHDA- 2021/11/25 06:00
PMCR- 2021/05/03
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- 2021/05/03 00:00 [pmc-release]
AID - 6263929 [pii]
AID - sjaa382 [pii]
AID - 10.1093/asj/sjaa382 [doi]
PST - ppublish
SO  - Aesthet Surg J. 2021 Nov 12;41(12):1423-1438. doi: 10.1093/asj/sjaa382.