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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
Results First Received: August 11, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Glabellar Frown Lines
Interventions: Drug: Botulinum type A toxin (Dysport RU)
Drug: Botulinum type A toxin (Azzalure)
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study was performed as a multicentre study at eight investigational sites in France and Germany. Date of first enrolment: 30-Mar-2011 and Date of last completed: 27-Sep-2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 178 patients were screened. 2 patient did not meet the entry criteria. 176 patients were randomized.Patients were randomized into 5 groups.

Reporting Groups
  Description
Placebo Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
Dysport NG 20 U

Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)

Ready to Use (RU)

Dysport NG 50 U Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
Dysport NG 75 U Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
Dysport 50 U Botulinum type A toxin (Azzalure), Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)

Participant Flow:   Overall Study
    Placebo   Dysport NG 20 U   Dysport NG 50 U   Dysport NG 75 U   Dysport 50 U
STARTED   35   36   35   35   35 
COMPLETED   34   36   35   34   35 
NOT COMPLETED   1   0   0   1   0 
Lost to Follow-up                1                0                0                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
Dysport NG 20 U Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
Dysport NG 50 U Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
Dysport NG 75 U Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
Dysport 50 U Botulinum type A toxin (Azzalure), Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
Total Total of all reporting groups

Baseline Measures
   Placebo   Dysport NG 20 U   Dysport NG 50 U   Dysport NG 75 U   Dysport 50 U   Total 
Overall Participants Analyzed 
[Units: Participants]
 35   36   35   35   35   176 
Age 
[Units: Years]
Mean (Standard Deviation)
 46.8  (6.4)   46.7  (8.4)   48.1  (6.9)   47.9  (6.0)   47.0  (6.6)   47.3  (6.9) 
Gender, Customized 
[Units: Participants]
           
Female   35   36   35   35   35   176 
Race/Ethnicity, Customized 
[Units: Participants]
           
Hispanic or Latino   0   2   0   2   1   5 
Not Hispanic or Latino   35   34   35   33   34   171 
Race/Ethnicity, Customized 
[Units: Participants]
           
White   35   36   35   35   35   176 


  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   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 ]

3.  Secondary:   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 ]

4.  Secondary:   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 ]

5.  Secondary:   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 ]

6.  Secondary:   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 ]

7.  Secondary:   Percentage of Subjects as Responders at Maximum Frown on Day 29 Who Remain Responders   [ Time Frame: Day 113 ]

8.  Secondary:   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 ]

9.  Secondary:   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 ]

10.  Secondary:   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 ]

11.  Secondary:   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 ]

12.  Secondary:   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 ]

13.  Secondary:   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 ]

14.  Secondary:   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 ]

15.  Other Pre-specified:   Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study   [ Time Frame: Up to Day 113 (±3 days) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Ipsen
phone: clinical.trials@ipsen.com
e-mail: clinical.trials@ipsen.com



Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01333397     History of Changes
Other Study ID Numbers: Y-52-52120-146
2010-019085-82 ( EudraCT Number )
Study First Received: April 8, 2011
Results First Received: August 11, 2015
Last Updated: September 29, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices