PMID- 17241416
OWN - NLM
STAT- MEDLINE
DCOM- 20070223
LR  - 20220311
IS  - 1076-0512 (Print)
IS  - 1076-0512 (Linking)
VI  - 33
IP  - 1 Spec No.
DP  - 2007 Jan
TI  - Dose-finding, safety, and tolerability study of botulinum toxin type B for the 
      treatment of hyperfunctional glabellar lines.
PG  - S60-8
AB  - BACKGROUND: Previous open-label studies have demonstrated that botulinum toxin 
      type B (BTX-B, Myobloc, Solstice Neurosciences) in doses of up to 3,000 U is safe 
      and effective in the treatment of glabellar wrinkles. OBJECTIVE: This 
      double-blind, randomized, placebo-controlled, sequential-dose-escalation study 
      evaluated the safety and tolerability of seven BTX-B doses ranging from 250 to 
      3,000 U in the treatment of subjects with hyperfunctional glabellar lines. 
      METHODS: Participants received a single intramuscular treatment of either BTX-B 
      or placebo at five facial sites with a 12-week follow-up period. Primary efficacy 
      outcome measure was the Investigator Global Scale score of subject's glabellar 
      lines at rest and at full frown. Safety was evaluated primarily on the occurrence 
      of adverse events (AEs). RESULTS: The investigator scores demonstrated a 
      statistically significant increasing dose-response trend in the percentage of 
      subjects with no lines or mild lines at rest from Weeks 1 to 12 (p=.0420) and at 
      full frown from Weeks 1 to 8 (p<.0001). Fifty-one subjects (36.7%) experienced 
      AEs; the most common AE was headache not otherwise specified, experienced by 19 
      subjects (13.7%). CONCLUSIONS: BTX-B at doses up to 3,000 U was safe and well 
      tolerated in the treatment of hyperfunctional glabellar lines. Treatment with 
      BTX-B reduced hyperfunctional glabellar lines in subjects, and the duration of 
      action appeared to be related to the dose administered. Further studies using 
      higher doses of BTX-B for treatment of glabellar wrinkles are planned.
FAU - Carruthers, Alastair
AU  - Carruthers A
AD  - University of British Columbia, Vancouver, British Columbia, Canada. 
      alastair@carruthers.net
FAU - Carruthers, Jean
AU  - Carruthers J
FAU - Flynn, Timothy Corcoran
AU  - Flynn TC
FAU - Leong, Michael S
AU  - Leong MS
LA  - eng
PT  - Clinical Conference
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  - 0Y70779M1F (rimabotulinumtoxinB)
RN  - EC 3.4.24.69 (Botulinum Toxins)
RN  - EC 3.4.24.69 (Botulinum Toxins, Type A)
SB  - IM
MH  - Adult
MH  - Botulinum Toxins/*administration & dosage/adverse effects
MH  - Botulinum Toxins, Type A
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Tolerance
MH  - Female
MH  - Humans
MH  - Injections, Intramuscular
MH  - Male
MH  - Middle Aged
MH  - Patient Satisfaction
MH  - Skin Aging/*drug effects
MH  - Treatment Outcome
EDAT- 2007/01/24 09:00
MHDA- 2007/02/24 09:00
CRDT- 2007/01/24 09:00
PHST- 2007/01/24 09:00 [pubmed]
PHST- 2007/02/24 09:00 [medline]
PHST- 2007/01/24 09:00 [entrez]
AID - DSU32333 [pii]
AID - 10.1111/j.1524-4725.2006.32333.x [doi]
PST - ppublish
SO  - Dermatol Surg. 2007 Jan;33(1 Spec No.):S60-8. doi: 
      10.1111/j.1524-4725.2006.32333.x.