Safety and Efficacy Study of Dysport RU and Glabellar Lines

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01333397
First received: April 8, 2011
Last updated: September 29, 2015
Last verified: September 2015

April 8, 2011
September 29, 2015
March 2011
September 2011   (final data collection date for primary outcome measure)
Percentage of Subjects as Responders in the ILA (Using Validated 4-point Photographic Scale) and the SSA of Glabellar Lines at Maximum Frown [ Time Frame: Day 29 ] [ Designated as safety issue: No ]

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.

Investigator's live assessment (using validated 4-point photographic scale) and the subject's self-assessment [ Time Frame: Day 1, 8, 15, 29, 57, 85 and 113 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01333397 on ClinicalTrials.gov Archive Site
  • Percentage of Subjects as Assessed as Responders, by Both Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
    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.
  • Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment. [ Time Frame: Days 8, 15, 57, 85 and 113 ] [ Designated as safety issue: No ]
  • Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment. [ Time Frame: Days 8, 15, 57, 85 and 113 ] [ Designated as safety issue: No ]
  • Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. [ Time Frame: Days 8, 15, 57, 85 and 113 ] [ Designated as safety issue: No ]
  • Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment. [ Time Frame: Days 8, 15, 29, 57, 85 and 113 ] [ Designated as safety issue: No ]
    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.
  • Percentage of Subjects as Responders at Maximum Frown on Day 29 Who Remain Responders [ Time Frame: Day 113 ] [ Designated as safety issue: No ]
    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.
  • 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 [ Time Frame: Days 8, 15, 29, 57, 85 and 113 ] [ Designated as safety issue: No ]
    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
  • 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 [ Time Frame: Days 8, 15, 29, 57, 85 and 113 ] [ Designated as safety issue: No ]
    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.
  • 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 [ Time Frame: Days 8, 15, 29, 57, 85 and 113 ] [ Designated as safety issue: No ]
    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.
  • Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U) [ Time Frame: Days 8, 15, 29, 57, 85 and 113 ] [ Designated as safety issue: No ]
  • Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U) [ Time Frame: Days 8, 15, 29, 57, 85 and 113 ] [ Designated as safety issue: No ]
  • Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U) [ Time Frame: Days 8, 15, 29, 57, 85 and 113 ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
Not Provided
Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study [ Time Frame: Up to Day 113 (±3 days) ] [ Designated as safety issue: Yes ]
Treatment Emergent Adverse Event (TEAE)
Not Provided
 
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Glabellar Frown Lines
  • Drug: Botulinum type A toxin (Dysport RU)
    I.M. (in the muscle) injection on day 1 (single treatment cycle)
  • Drug: Botulinum type A toxin (Azzalure)
    I.M. on day 1 (single treatment cycle)
  • Drug: Placebo
    I.M. on day 1 (single treatment cycle)
  • Experimental: Dysport RU 20 U
    Intervention: Drug: Botulinum type A toxin (Dysport RU)
  • Experimental: Dysport RU 50 U
    Intervention: Drug: Botulinum type A toxin (Dysport RU)
  • Experimental: Dysport RU 75 U
    Intervention: Drug: Botulinum type A toxin (Dysport RU)
  • Active Comparator: Dysport (Azzalure) 50 U
    Intervention: Drug: Botulinum type A toxin (Azzalure)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
176
September 2011
September 2011   (final data collection date for primary outcome measure)

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.
Female
30 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany
 
NCT01333397
Y-52-52120-146, 2010-019085-82
No
Not Provided
Not Provided
Ipsen
Ipsen
Not Provided
Study Director: Ipsen Study Director Ipsen
Ipsen
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP