Glabellar Frown LinesPhase 2NCT01333397
Safety and Efficacy Study of Dysport RU and Glabellar Lines
A Phase 2 study testing Botulinum toxin type A in people with Glabellar Frown Lines, run by Ipsen at 8 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Glabellar Frown Lines
- What is being tested?
- Botulinum toxin type A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Mar 2011to Sep 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female between 30 - 60 years of age
- Moderate to severe vertical glabellar lines at maximum frown at baseline
Who cannot join
- 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.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
France4 sites
Private practice
Bordeaux
Private practice
Cannes
Private practice
Juan-les-Pins
Private practice
Paris
Germany4 sites
Charité hospital
Berlin
Private clinic
Dresden
Private clinic
Munich
Private clinic
Starnberg
About this study
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
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.
- Conditions
- Glabellar Frown Lines
- Being tested
- Botulinum toxin type A, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type ABiological
Also called AbobotulinumtoxinA (DysportRU®)
I.M. (in the muscle) injection on day 1 (single treatment cycle)
Botulinum toxin type ABiological
Also called AbobotulinumtoxinA (Azzalure®)
I.M. on day 1 (single treatment cycle)
PlaceboDrug
I.M. on day 1 (single treatment cycle)
| Study group | Role | What they receive |
|---|---|---|
| Dysport RU 20 U | Experimental | Not described Receives: Biological: Botulinum toxin type A |
| Dysport RU 50 U | Experimental | Not described Receives: Biological: Botulinum toxin type A |
| Dysport RU 75 U | Experimental | Not described Receives: Biological: Botulinum toxin type A |
| Dysport (Azzalure) 50 U | Active comparator | Not described Receives: Biological: Botulinum toxin type A |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 29
Secondary outcomes (13)
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.
Measured: Day 29
Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment.
Measured: Days 8, 15, 57, 85 and 113
Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment.
Measured: Days 8, 15, 57, 85 and 113
Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown.
Measured: Days 8, 15, 57, 85 and 113
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.
Measured: Days 8, 15, 29, 57, 85 and 113
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.
Measured: Day 113
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
Measured: Days 8, 15, 29, 57, 85 and 113
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.
Measured: Days 8, 15, 29, 57, 85 and 113
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.
Measured: Days 8, 15, 29, 57, 85 and 113
Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U)
Measured: Days 8, 15, 29, 57, 85 and 113
Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U)
Measured: Days 8, 15, 29, 57, 85 and 113
Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U)
Measured: Days 8, 15, 29, 57, 85 and 113
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)
Measured: Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Glabellar Frown LinesStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Study Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333397
- Sponsor's protocol ID
- Y-52-52120-146
- Other IDs
- 2010-019085-82
- Status last verified
- Sep 2022
- First submitted
- 8 Apr 2011
- Last updated
- 27 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01333397
- Acronym / sponsor ID
- Y-52-52120-146
- Conditions
- Glabellar Frown Lines
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 12 Apr 2011 (estimated)
- Results
- Posted 30 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dysport RU 20 U | Experimental | Biological: Botulinum toxin type A |
| Dysport RU 50 U | Experimental | Biological: Botulinum toxin type A |
| Dysport RU 75 U | Experimental | Biological: Botulinum toxin type A |
| Dysport (Azzalure) 50 U | Active comparator | Biological: Botulinum toxin type A |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female between 30 - 60 years of age
- Moderate to severe vertical glabellar lines at maximum frown at baseline
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin type AAlso: AbobotulinumtoxinA (DysportRU®)I.M. (in the muscle) injection on day 1 (single treatment cycle) | Biological | Dysport RU 20 U, Dysport RU 50 U, Dysport RU 75 U |
| Botulinum toxin type AAlso: AbobotulinumtoxinA (Azzalure®)I.M. on day 1 (single treatment cycle) | Biological | Dysport (Azzalure) 50 U |
| PlaceboI.M. on day 1 (single treatment cycle) | Drug | Placebo |
Primary outcome
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.
13 secondary outcomes
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
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
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
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
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
Percentage of Subjects as Responders at Maximum Frown on Day 29 Who Remain Responders
Time frame: Day 113
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
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
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
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Study Director study director
Ipsen
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botulinum toxin type A in people with Glabellar Frown Lines, run by Ipsen at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022.