Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study I



Status:Active, not recruiting
Healthy:No
Age Range:18 - 75
Updated:2/3/2017
Start Date:February 2016
End Date:March 2018

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Randomized Double Blind Phase 3 Study to Assess the Efficacy and Safety of BoNT/A-DP in the Treatment of Glabellar Lines in Comparison With Placebo, Followed by an Open Label Extension Study

The aim of this study is to assess the efficacy and safety of BoNT/A-DP in the treatment of
glabellar lines in comparison with placebo, including efficacy after repeat treatments and
long term safety.


Inclusion Criteria:

- Aged ≥ 18 years or older at time of screening

- Has moderate to severe glabellar frown lines at maximum frown (severity score of 2 or
3 on FWS) as determined by in-clinic assessments by both the investigator and the
subject(where: 0= 'none', 1= 'mild', 2= 'moderate', 3= 'severe').

- 18 years of age

Exclusion Criteria:

- Any medical condition that may place the subject at increased risk due to exposure to
botulinum toxin, including diagnosed myasthenia gravis, Eaton Lambert syndrome,
amyotrophic lateral sclerosis, profound atrophy or weakness in the target muscles, or
any other condition (at the investigator's discretion) that might interfere with
neuromuscular function or contraindicate botulinum toxin therapy.

- Previous treatment with any serotype of botulinum toxin for any indication within the
12 months prior to screening, or any planned treatment with botulinum toxin of any
serotype for any reason during the trial (other than the investigational treatment).

- Active skin disease/infection or irritation at the treatment area

- Pregnant, breastfeeding or planning to become pregnant during the trial.
We found this trial at
1
site
Nashville, Tennessee 37215
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mi
from
Nashville, TN
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