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

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.

Study Overview

• Status: Completed
• Conditions: Glabellar Frown Lines
• Intervention / Treatment: Biological: Botulinum toxin type A; Biological: Botulinum toxin type A; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 176
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • Private Practice
  • Cannes, France
    • Private Practice
  • Juan Les Pins, France
    • Private Practice
  • Paris, France
    • Private Practice
• Germany
  • Berlin, Germany
    • Charité Hospital
  • Dresden, Germany
    • Private Clinic
  • Munich, Germany
    • Private Clinic
  • Starnberg, Germany
    • Private Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female between 30 - 60 years of age
• Moderate to severe vertical glabellar lines at maximum frown at baseline

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; I.M. on day 1 (single treatment cycle)
Experimental: Dysport RU 20 U	Biological: Botulinum toxin type A; I.M. (in the muscle) injection on day 1 (single treatment cycle); Other Names: AbobotulinumtoxinA (DysportRU®); Biological: Botulinum toxin type A; I.M. on day 1 (single treatment cycle); Other Names: AbobotulinumtoxinA (Azzalure®)
Experimental: Dysport RU 50 U	Biological: Botulinum toxin type A; I.M. (in the muscle) injection on day 1 (single treatment cycle); Other Names: AbobotulinumtoxinA (DysportRU®); Biological: Botulinum toxin type A; I.M. on day 1 (single treatment cycle); Other Names: AbobotulinumtoxinA (Azzalure®)
Experimental: Dysport RU 75 U	Biological: Botulinum toxin type A; I.M. (in the muscle) injection on day 1 (single treatment cycle); Other Names: AbobotulinumtoxinA (DysportRU®); Biological: Botulinum toxin type A; I.M. on day 1 (single treatment cycle); Other Names: AbobotulinumtoxinA (Azzalure®)
Active Comparator: Dysport (Azzalure) 50 U	Biological: Botulinum toxin type A; I.M. (in the muscle) injection on day 1 (single treatment cycle); Other Names: AbobotulinumtoxinA (DysportRU®); Biological: Botulinum toxin type A; I.M. on day 1 (single treatment cycle); Other Names: AbobotulinumtoxinA (Azzalure®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects as Assessed as Responders, by Both Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown.	A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on the visit day and a severity grade of moderate or severe at maximum frown at Visit 2.	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.	A responder at rest was defined as a subject having a severity grade of none or mild at rest on the visit day and a severity grade of moderate or severe at rest at Visit 2.	Days 8, 15, 29, 57, 85 and 113
Percentage of Subjects as Responders at Maximum Frown on Day 29 Who Remain Responders	A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on the visit day and a severity grade of moderate or severe at maximum frown at Visit 2.	Day 113
Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Investigator's Live Assessment	A reduction of two or more grades in the severity of glabellar lines at maximum frown was a change from Visit 2 severity of glabellar lines from severe to mild/none or from Visit 2 severity of moderate to none after treatment as measured by the Investigator's live assessment	Days 8, 15, 29, 57, 85 and 113
Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Rest as Measured by the Investigator's Live Assessment	A reduction of two or more grades in the severity of glabellar lines at rest was a change from Visit 2 severity of glabellar lines from severe to mild or from Visit 2 severity of moderate to none after treatment as measured by the Investigator's live assessment.	Days 8, 15, 29, 57, 85 and 113
Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Subject's Self-assessment	A reduction of two or more grades in the severity of glabellar lines at maximum frown was a change from Visit 2 severity of glabellar lines from severe to mild/no wrinkles or from Visit 2 severity of moderate to no wrinkles after treatment as measured by the subjects self assessment.	Days 8, 15, 29, 57, 85 and 113
Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U)		Days 8, 15, 29, 57, 85 and 113
Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U)		Days 8, 15, 29, 57, 85 and 113
Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U)		Days 8, 15, 29, 57, 85 and 113
Percentage of Subjects as Responders at Day 29 by the Investigator's Live Assessment and by Subject's Self Assessment of Glabellar Lines at Maximum Frown (Assay Sensitivity)		Day 29

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study	Treatment Emergent Adverse Event (TEAE)	Up to Day 113 (±3 days)

Collaborators and Investigators

• Sponsor: Ipsen

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: April 8, 2011
• First Submitted That Met QC Criteria: April 8, 2011
• First Posted (Estimate): April 12, 2011

Study Record Updates

• Last Update Posted (Actual): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 15, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: Y-52-52120-146; 2010-019085-82 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing Access Criteria: Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).