Trials / Completed
CompletedNCT01333397
Safety and Efficacy Study of Dysport RU and Glabellar Lines
A Phase II, Double Blind, Randomised, Placebo and Active Comparator Controlled Study to Assess the Safety and Efficacy of Three Doses of Dysport RU (20 U, 50 U, and 75 U) Administered as a Single Treatment Cycle to Improve the Appearance of Moderate to Severe Glabellar Lines
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 176 (actual)
- Sponsor
- Ipsen · Industry
- Sex
- Female
- Age
- 30 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective is to assess the dose response versus placebo of a single treatment of Dysport RU (Dysport RU, Ready to Use, for injection), for the improvement in appearance of moderate to severe glabellar lines at maximum frown.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Botulinum toxin type A | I.M. (in the muscle) injection on day 1 (single treatment cycle) |
| BIOLOGICAL | Botulinum toxin type A | I.M. on day 1 (single treatment cycle) |
| DRUG | Placebo | I.M. on day 1 (single treatment cycle) |
Timeline
- Start date
- 2011-03-01
- Primary completion
- 2011-09-01
- Completion
- 2011-09-01
- First posted
- 2011-04-12
- Last updated
- 2022-09-27
- Results posted
- 2015-10-30
Locations
8 sites across 2 countries: France, Germany
Source: ClinicalTrials.gov record NCT01333397. Inclusion in this directory is not an endorsement.