A Study Of BOTOX For The Treatment Of Glabellar Lines
Status and phase
Completed
Phase 3
Conditions
Glabellar Lines
Treatments
Drug: Botulinum Toxin Type A
Drug: sodium chloride
Details and patient eligibility
About
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.
Sex
All
Ages
18 to 65 years old
Volunteers
No Healthy Volunteers
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 design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
256 participants in 2 patient groups, including a placebo group
A
Experimental group
Description:
Injection
Treatment:
Drug: Botulinum Toxin Type A
B
Placebo Comparator group
Description:
Injection
Treatment:
Drug: sodium chloride
Trial contacts and locations
4
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Data sourced from clinicaltrials.gov
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