PMID- 32773447
OWN - NLM
STAT- MEDLINE
DCOM- 20210416
LR  - 20230814
IS  - 1524-4725 (Electronic)
IS  - 1076-0512 (Print)
IS  - 1076-0512 (Linking)
VI  - 47
IP  - 1
DP  - 2021 Jan 1
TI  - A Large, Open-Label, Phase 3 Safety Study of DaxibotulinumtoxinA for Injection in 
      Glabellar Lines: A Focus on Safety From the SAKURA 3 Study.
PG  - 42-46
LID - 10.1097/DSS.0000000000002463 [doi]
AB  - BACKGROUND: SAKURA 3 was a Phase 3, open-label, repeat-dose safety study of 
      DaxibotulinumtoxinA for Injection (DAXI); a component of the largest Phase 3 
      clinical development program of an aesthetic neuromodulator in glabellar lines. 
      OBJECTIVE: To evaluate the use of DAXI (40U) up to 3 treatments for moderate or 
      severe glabellar lines. METHODS: Eligible subjects rolled over from the 
      placebo-controlled trials (n = 477) or were de novo (n = 2,214) and received 1 to 
      3 treatments over a maximum of 84 weeks. Safety and efficacy were evaluated at 
      least every 4 weeks up to Week 36 (Treatments 1 and 2) and Week 12 (Treatment 3). 
      Select subjects could be retreated after Week 12 if glabellar lines returned to 
      baseline. RESULTS: Safety results are reported for 2,691 subjects, of which 882 
      received a second treatment and 568 a third. Treatment-related adverse events 
      (AEs) occurred in 17.8% of subjects, which were generally mild and resolved. No 
      serious AEs were treatment-related. Eyelid ptosis occurred in 0.9% of treatments. 
      Adverse events were consistent across treatments and no new safety signals were 
      observed. CONCLUSION: The safety of DAXI in this large open-label safety study 
      confirms the findings from the pivotal Phase 3 trials, providing reassurance in 
      its overall safety profile.
CI  - Copyright (c) 2020 The Author(s). Published by Wolters Kluwer Health, Inc. on 
      behalf of the American Society for Dermatologic Surgery, Inc.
FAU - Green, Jeremy B
AU  - Green JB
AD  - Skin Associates of South Florida, Coral Gables, Florida.
FAU - Mariwalla, Kavita
AU  - Mariwalla K
AD  - Mariwalla Dermatology, West Islip, New York.
FAU - Coleman, Kyle
AU  - Coleman K
AD  - Etre Cosmetic Dermatology and Laser Center, New Orleans, Louisiana.
FAU - Ablon, Glynis
AU  - Ablon G
AD  - Ablon Skin Institute & Research Center, Manhattan Beach, California.
FAU - Weinkle, Susan H
AU  - Weinkle SH
AD  - University of South Florida, Tampa and Private Practice, Bradenton, Florida.
FAU - Gallagher, Conor J
AU  - Gallagher CJ
AD  - Revance Therapeutics, Inc., Newark, California.
FAU - Vitarella, Domenico
AU  - Vitarella D
AD  - Revance Therapeutics, Inc., Newark, California.
FAU - Rubio, Roman G
AU  - Rubio RG
AD  - Revance Therapeutics, Inc., Newark, California.
LA  - eng
SI  - ClinicalTrials.gov/NCT03004248
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
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
CIN - Dermatol Surg. 2021 Jan 1;47(1):47. PMID: 32796331
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Botulinum Toxins, Type A/adverse effects/*therapeutic use
MH  - Female
MH  - *Forehead
MH  - Humans
MH  - Injections
MH  - Male
MH  - Middle Aged
MH  - Neuromuscular Agents/adverse effects/*therapeutic use
MH  - Skin Aging/*drug effects
PMC - PMC7752221
COIS- J.B. Green, K. Mariwalla, K. Coleman, and G. Ablon have served as clinical trial 
      investigators for Revance Therapeutics, Inc. S.H. Weinkle has served as a 
      clinical trial investigator and consultant for Revance Therapeutics, Inc. D. 
      Vitarella, C.J. Gallagher, and R.G. Rubio are employees of, and hold stock/stock 
      options in Revance Therapeutics, Inc.
EDAT- 2020/08/11 06:00
MHDA- 2021/04/17 06:00
PMCR- 2020/12/21
CRDT- 2020/08/11 06:00
PHST- 2020/08/11 06:00 [pubmed]
PHST- 2021/04/17 06:00 [medline]
PHST- 2020/08/11 06:00 [entrez]
PHST- 2020/12/21 00:00 [pmc-release]
AID - 00042728-202101000-00012 [pii]
AID - ds-00114-2020 [pii]
AID - 10.1097/DSS.0000000000002463 [doi]
PST - ppublish
SO  - Dermatol Surg. 2021 Jan 1;47(1):42-46. doi: 10.1097/DSS.0000000000002463.