Overview

Safety and Efficacy Study of Botulinum Toxin for the Treatment of Glabellar Frown Lines

Status:
Completed
Trial end date:
2015-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Q-Med AB
Treatments:
abobotulinumtoxinA
Botulinum Toxins
Botulinum Toxins, Type A
incobotulinumtoxinA
onabotulinumtoxinA
Criteria
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