Glabellar Frown Lines
Conditions
Brief summary
The primary objective of the study is to evaluate the efficacy in wrinkle reduction of a single treatment of three different doses of botulinum toxin compared to placebo, in the treatment of moderate to very severe glabellar frown lines.
Interventions
DRUGBotulinum Toxin Type A
DRUGPlacebo
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Moderate to Very Severe glabellar lines at maximum frown as assessed by the subject and the Investigator and at least Mild glabellar lines at rest
Exclusion criteria
* Any previous treatment with any botulinum toxin * Rhytids of the glabellar region that cannot be smoothed out by manually spreading the skin apart * Any previous insertion of any permanent or semi-permanent material, hyaluronic acid or collagen fillers to the glabellar region * Any history of facial surgery above the lower orbital rim * Any planned facial surgery or aesthetic procedure during the study period * Ablative skin resurfacing or chemical peels above the lower orbital rim in the previous 12 months or during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of glabellar frown line severity on Day 14 following treatment with botulinum toxin | 14 Days | Reduction in glabellar frown line severity is derived separately for the Investigator and the subject assessment, using a validated photo scale, at maximum frown on Day 14. |
Countries
United States
Outcome results
None listed