Status:
COMPLETED
Safety and Efficacy Study of Botulinum Toxin for the Treatment of Glabellar Frown Lines
Lead Sponsor:
Galderma R&D
Conditions:
Glabellar Frown Lines
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
359 Patients enrolled
Trial Details
Trial ID
NCT02236312
Start Date
September 1 2014
End Date
May 1 2015
Last Update
August 26 2022
Active Locations (8)
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1
Private practice
Birmingham, Alabama, United States
2
Private practice
Mobile, Alabama, United States
3
Private practice
San Diego, California, United States
4
Private practice
Englewood, Colorado, United States