Safety and Efficacy Study of Dysport RU and Glabellar Lines
NCT ID: NCT01333397
Last Updated: 2022-09-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
176 participants
INTERVENTIONAL
2011-03-31
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Dysport RU 20 U
Botulinum toxin type A
I.M. (in the muscle) injection on day 1 (single treatment cycle)
Dysport RU 50 U
Botulinum toxin type A
I.M. (in the muscle) injection on day 1 (single treatment cycle)
Dysport RU 75 U
Botulinum toxin type A
I.M. (in the muscle) injection on day 1 (single treatment cycle)
Dysport (Azzalure) 50 U
Botulinum toxin type A
I.M. on day 1 (single treatment cycle)
Placebo
Placebo
I.M. on day 1 (single treatment cycle)
Interventions
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Botulinum toxin type A
I.M. (in the muscle) injection on day 1 (single treatment cycle)
Botulinum toxin type A
I.M. on day 1 (single treatment cycle)
Placebo
I.M. on day 1 (single treatment cycle)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Moderate to severe vertical glabellar lines at maximum frown at baseline
Exclusion Criteria
* Any prior treatment with fillers (e.g. collagen-type implants) skin abrasions or photorejuvenation within the previous 12 months
* Any planned facial cosmetic surgery during the study period
* A history of ablative skin resurfacing of the area to be treated during the study.
30 Years
60 Years
FEMALE
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Study Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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Private practice
Bordeaux, , France
Private practice
Cannes, , France
Private practice
Juan-les-Pins, , France
Private practice
Paris, , France
Charité hospital
Berlin, , Germany
Private clinic
Dresden, , Germany
Private clinic
Munich, , Germany
Private clinic
Starnberg, , Germany
Countries
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Other Identifiers
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2010-019085-82
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Y-52-52120-146
Identifier Type: -
Identifier Source: org_study_id
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