PMID- 26863598
OWN - NLM
STAT- MEDLINE
DCOM- 20160708
LR  - 20220408
IS  - 1524-4725 (Electronic)
IS  - 1076-0512 (Linking)
VI  - 42
IP  - 3
DP  - 2016 Mar
TI  - Efficacy and Safety of OnabotulinumtoxinA Treatment of Forehead Lines: A 
      Multicenter, Randomized, Dose-Ranging Controlled Trial.
PG  - 410-9
LID - 10.1097/DSS.0000000000000626 [doi]
AB  - BACKGROUND: Various onabotulinumtoxinA doses are effective in treating forehead 
      lines (FHL), with a trend toward lower doses. OBJECTIVE: To evaluate efficacy and 
      safety of onabotulinumtoxinA dose-ranging treatment of FHL when the frontalis 
      area and glabellar complex are treated together. MATERIALS AND METHODS: Adults 
      with moderate-to-severe FHL received onabotulinumtoxinA 40 U (FHL, 20 U; 
      glabellar lines [GL], 20 U), 30 U (FHL, 10 U; GL, 20 U), or placebo. Response was 
      assessed at weeks 1, 2, day 30, and monthly to day 180. Coprimary efficacy end 
      points were investigator- and subject-assessed Facial Wrinkle Scale scores of 
      none or mild (day 30). Patient-reported outcomes, onset/duration of effect, and 
      adverse events (AEs) were evaluated. RESULTS: Responder rates 
      (investigator/subject, respectively) were 40-U group, 91.2%/89.5%; 30-U group, 
      86.4%/81.4%; placebo, 1.7%/5.1%. OnabotulinumtoxinA resulted in significantly 
      greater responder rates than placebo (p < .001). Adverse events were mild to 
      moderate and similar between groups (most common AEs: nasopharyngitis [4.6%] and 
      headache [4.0%]). CONCLUSION: Treatment of FHL with onabotulinumtoxinA 40 and 30 
      U (in frontalis and glabellar complex muscles) was tolerable, effective, and 
      sustained. Both doses significantly reduced FHL severity; however, the 40-U dose 
      demonstrated a trend toward greater sustained benefit and longer duration of 
      effect versus the 30-U dose, with similar AE rates.
FAU - Solish, Nowell
AU  - Solish N
AD  - *Department of Dermatology, University of Toronto, Toronto, Ontario, Canada; 
      daggerDepartment of Dermatology and Skin Science, University of British Columbia, 
      Vancouver, British Columbia, Canada, and Pacific Dermaesthetics, Vancouver, 
      British Columbia, Canada; double daggerDermetics, Burlington, Ontario, Canada, and Department 
      of Dermatology, McMaster University, Hamilton, Ontario, Canada;  section signAllergan plc, 
      Irvine, California;  ||Allergan plc, Markham, Ontario, Canada.
FAU - Rivers, Jason K
AU  - Rivers JK
FAU - Humphrey, Shannon
AU  - Humphrey S
FAU - Muhn, Channy
AU  - Muhn C
FAU - Somogyi, Chris
AU  - Somogyi C
FAU - Lei, Xiaofang
AU  - Lei X
FAU - Bhogal, Meetu
AU  - Bhogal M
FAU - Caulkins, Carrie
AU  - Caulkins C
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
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 (Acetylcholine Release Inhibitors)
RN  - EC 3.4.24.69 (Botulinum Toxins, Type A)
SB  - IM
MH  - Acetylcholine Release Inhibitors/*administration & dosage/adverse effects
MH  - Adult
MH  - Botulinum Toxins, Type A/*administration & dosage/adverse effects
MH  - Double-Blind Method
MH  - Female
MH  - Forehead
MH  - Headache/chemically induced
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Nasopharyngitis/chemically induced
MH  - Patient Satisfaction
MH  - Plasma Skin Regeneration/methods
MH  - Self Concept
MH  - Skin Aging/*drug effects
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 2016/02/11 06:00
MHDA- 2016/07/09 06:00
CRDT- 2016/02/11 06:00
PHST- 2016/02/11 06:00 [entrez]
PHST- 2016/02/11 06:00 [pubmed]
PHST- 2016/07/09 06:00 [medline]
AID - 10.1097/DSS.0000000000000626 [doi]
PST - ppublish
SO  - Dermatol Surg. 2016 Mar;42(3):410-9. doi: 10.1097/DSS.0000000000000626.