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OpenTrials
Completed

NCT Number: NCT01333397

Safety and Efficacy Study of Dysport RU and 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.

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Key information

Conditions

Glabellar Frown Lines

Age range

30 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Private practice, Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Botulinum toxin type A

Biological

I.M. (in the muscle) injection on day 1 (single treatment cycle)

Other names: AbobotulinumtoxinA (DysportRU®)

Placebo

Drug

I.M. on day 1 (single treatment cycle)

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. 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

    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.

  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

  3. 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

  4. 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

  5. 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

    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.

  6. Percentage of Subjects as Responders at Maximum Frown on Day 29 Who Remain Responders

    Time frame: Day 113

    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.

  7. 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

    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

  8. 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

    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.

  9. 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

    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.

  10. 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

  11. 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

  12. 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

  13. 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

Other outcomes

  1. Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study

    Time frame: Up to Day 113 (±3 days)

    Treatment Emergent Adverse Event (TEAE)

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 12, 2011
Registry last updated
Sep 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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