Safety and Efficacy Study of Dysport RU and Glabellar Lines

Glabellar Frown Lines Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01333397
• Other study ID #: Y-52-52120-146
• Secondary ID: 2010-019085-82
• Status: Completed
• Phase: Phase 2
• Start date: March 2011
• Est. completion date: September 2011

Study information

• Verified date: September 2022
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glabellar Frown Lines

Intervention

Biological:
• 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)

Drug:
• Placebo
I.M. on day 1 (single treatment cycle)

Locations

Country	Name	City	State
France	Private practice	Bordeaux
France	Private practice	Cannes
France	Private practice	Juan Les Pins
France	Private practice	Paris
Germany	Charité hospital	Berlin
Germany	Private clinic	Dresden
Germany	Private clinic	Munich
Germany	Private clinic	Starnberg

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	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	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
Secondary	Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment.		Days 8, 15, 57, 85 and 113
Secondary	Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment.		Days 8, 15, 57, 85 and 113
Secondary	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
Secondary	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
Secondary	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
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	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
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	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
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	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
Secondary	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
Secondary	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
Secondary	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
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)		Day 29