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
2 other identifiers
interventional
176
2 countries
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2011
Shorter than P25 for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 8, 2011
CompletedFirst Posted
Study publicly available on registry
April 12, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedResults Posted
Study results publicly available
October 30, 2015
CompletedSeptember 27, 2022
September 1, 2022
6 months
April 8, 2011
August 11, 2015
September 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Subjects as Responders in the ILA (Using Validated 4-point Photographic Scale) and the SSA of Glabellar Lines at Maximum Frown
Investigator's live assessment (ILA), subject's self assessment (SSA), Next Generation (NG) 4-point photographic scale: Investigator's live assessment: None - 0; Mild - 1; Moderate - 2; Severe - 3; 4-point photographic scale: Subject's Self assessment: No wrinkles - 0; Mild wrinkles - 1; Moderate wrinkles - 2; Severe wrinkles - 3; A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on Day 29 and a severity grade of moderate or severe at maximum frown at Visit 2.
Day 29
Secondary Outcomes (13)
Percentage of Subjects as Assessed as Responders, by Both Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown.
Day 29
Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment.
Days 8, 15, 57, 85 and 113
Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment.
Days 8, 15, 57, 85 and 113
Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown.
Days 8, 15, 57, 85 and 113
Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment.
Days 8, 15, 29, 57, 85 and 113
- +8 more secondary outcomes
Other Outcomes (1)
Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study
Up to Day 113 (±3 days)
Study Arms (5)
Dysport RU 20 U
EXPERIMENTALDysport RU 50 U
EXPERIMENTALDysport RU 75 U
EXPERIMENTALDysport (Azzalure) 50 U
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
I.M. (in the muscle) injection on day 1 (single treatment cycle)
Eligibility Criteria
You may qualify if:
- Female between 30 - 60 years of age
- Moderate to severe vertical glabellar lines at maximum frown at baseline
You may not qualify if:
- Silicone injections into the upper face
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (8)
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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Ipsen
Study Officials
- STUDY DIRECTOR
Ipsen Study Director
Ipsen
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2011
First Posted
April 12, 2011
Study Start
March 1, 2011
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
September 27, 2022
Results First Posted
October 30, 2015
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
- Access Criteria
- Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.