Phase 2
N=176
Safety and Efficacy Study of Dysport RU and Glabellar Lines
Glabellar Frown Lines
Bottom Line
View on ClinicalTrials.gov: NCT01333397 ↗Enrolled (actual)
176
Serious AEs
0.6%
Results posted
Oct 2015
Primary outcome: Primary: Percentage of Subjects as Responders in the ILA (Using Validated 4-point Photographic Scale) and the SSA of Glabellar Lines at Maximum Frown — 0; 88.9; 91.4; 87.9 percentage of subjects — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Botulinum toxin type A (Biological); Placebo (Drug)
- Age
- Adult · 30+ yrs
- Sex
- Female
- Sponsor
- Ipsen
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects as Responders in the ILA (Using Validated 4-point Photographic Scale) and the SSA of Glabellar Lines at Maximum Frown |
0; 88.9; 91.4; 87.9; 2.9; 91.7 | <0.0001 sig |
| SECONDARY Percentage of Subjects as Assessed as Responders, by Both Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. |
0; 86.1; 85.7; 81.8; 77.1 | — |
| SECONDARY Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment. |
0; 77.8; 80.0; 82.9; 3.0; 80.6 | — |
| SECONDARY Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment. |
2.9; 66.7; 65.7; 74.3; 3.0; 80.6 | — |
| SECONDARY Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown. |
0; 61.1; 62.9; 74.3; 51.4; 0 | — |
| SECONDARY Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment. |
11.1; 70.6; 76.9; 71.4; 11.1; 70.6 | — |
| SECONDARY Percentage of Subjects as Responders at Maximum Frown on Day 29 Who Remain Responders |
0; 25.0; 46.9; 65.5; 40.7; 0 | — |
| 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 |
0; 30.6; 45.7; 45.7; 31.4; 0 | — |
| 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 |
5.6; 5.9; 23.1; 21.4; 10.5; 5.6 | — |
| 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 |
0; 25.0; 42.9; 40.0; 34.3; 0 | — |
| SECONDARY Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U) |
77.8; 80.0; 82.9; 57.1; 80.6; 94.3 | — |
| SECONDARY Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U) |
66.7; 65.7; 74.3; 57.1; 80.6; 82.9 | — |
| SECONDARY Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U) |
70.6; 76.9; 71.4; 63.2; 70.6; 92.3 | — |
| 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) |
0; 77.1; 2.9; 82.9 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01333397). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.