Last updated: 11/03/2018 09:37:37
A Study Of BOTOX For The Treatment Of Glabellar Lines
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of BOTOX? (Botulinum Toxin Type A) in Subjects with Glabellar Lines
Trial description: This is a Multicenter, double-blind, randomized, placebo-controlled, parallel-group comparative study to confirm the efficacy and safety of BOTOX 20 units single injection for the Chinese patients with glabellar lines. The subjects will receive a single intramuscular treatment consisting of 5 injections of either BOTOX? 20U or placebo.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Number of Participants With a Facial Wrinkle Scale Assessment of None or Mild at Maximum Frown
Timeframe: at Day 7, 30, 60, 90 and 120
Secondary outcomes:
Number of participants with a Facial Wrinkle Scale Assessment of None or Mild at rest
Timeframe: Day 7, 30, 60, 90, 120 after injection
Number of participants with at least Moderate (+2) Improvement in Global Assessment of change in appearance of glabellar line severity
Timeframe: At day 7, 30, 60, 90,120
Participants perception of age
Timeframe: At Day 7,30, 60,90,120
Number of participants with Adverse events (AE) and serious adverse event (SAE)
Timeframe: Upto 10 months
Number of participants with shift in Systolic and diastolic blood pressure, and Heart rate from baseline to Day 30
Timeframe: Baseline ( Day 0) and Day 30
Number of participants with abnormal hematology parameters
Timeframe: Up to day 30
Number of participants with clinical chemistry parameters
Timeframe: Up to day 30
Number of participants with abnormal urinalysis data- Glucose, protein, RBC, WBC and urobilinogen
Timeframe: Day 30
Interventions:
Drug: Botulinum Toxin Type A
Drug: sodium chloride
Enrollment:
247
Observational study model:
Not applicable
Primary completion date:
2007-05-09
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Glabellar lines
Product
OnabotulinumtoxinA
Collaborators
Not applicable
Study date(s)
November 2006 to September 2007
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
- Male and female adult with Glabellar lines of at least moderate severity at maximum frown by investigator’s assessment.
- Patients with systemic nerve conduction junction disorder or patients with infection or other skin disease/surgery at injection sites will not be eligible.
- Patient with severe complications related to heart, kidney, liver disease or respiratory system will not be eligible.
Inclusion and exclusion criteria
Inclusion criteria:
- Male and female adult with Glabellar lines of at least moderate severity at maximum frown by investigator’s assessment.
Exclusion criteria:
- Patients with systemic nerve conduction junction disorder or patients with infection or other skin disease/surgery at injection sites will not be eligible.
- Patient with severe complications related to heart, kidney, liver disease or respiratory system will not be eligible.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-05-09
Actual study completion date
2007-05-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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