Glabellar LinesPhase 3NCT02450526

Dysport in the Treatment of Glabellar Lines in Chinese Subjects

A Phase 3 study testing Botulinum toxin type A in people with Glabellar Lines, run by Ipsen at 10 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objective of this study is to demonstrate the efficacy of Dysport for the improvement in appearance of moderate to severe glabellar lines and to assess the short term and long term safety of Dysport, used for the improvement in appearance of moderate to severe glabellar lines in Chinese subjects. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Glabellar 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: 520 participants
Where: 10 sitesChina
Study dates: Apr 2015to 6 Sep 2017
Phase: Phase 3
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provision of written informed consent
Male or female Chinese subjects who are between 18 to 65 years of age inclusive.
Have moderate or severe wrinkles of vertical glabellar lines (Grade 2 or 3) at maximum frown at baseline (Day 1), as assessed by the subject using SSA.
Have moderate or severe (Grade 2 or 3) vertical glabellar lines at maximum frown at baseline (Day 1), as assessed by the Investigator using ILA.
Be Botulinum Toxin (BTX) naïve or have received their most recent BTX-A treatment more than 1 year prior to screening.
Have a negative pregnancy test
Have an understanding of the study

Who cannot join

Any prior surgery affecting corrugator supercilii, prior blepharoplasty or brow lift, dermal resurfacing, or any prior cosmetic procedures or scars within 36 months.
Any prior treatment with permanent fillers in the upper face.
Any prior treatment with nonpermanent dermal fillers in the upper face within the past 3 years and/or skin abrasions/resurfacing, photorejuvenation or skin/vascular laser intervention within the past 12 months.
Any planned facial cosmetic surgery or procedures during the study period.
Lack of capacity to frown.
Facial conditions that could affect safety or efficacy results.

Show all 19Show fewer

History of facial nerve palsy.
Marked asymmetry; ptosis; excessive dermatochalasis; deep dermal scarring; thick sebaceous skin; photodamage etc.
Presence of any condition that could affect the safety, conduct or outcome of the study.
Any subjects who have any psychiatric illness or are taking antidepressant, anxiolytic or antipsychotic medication.
Pregnant and/or lactating female subjects.
Female subjects of childbearing potential not willing to use contraceptive measures throughout the course of the study.
History of drug or alcohol abuse.
Treatment with an experimental drug or device within 30 days prior to screening for this study and during the conduct of this study.
Requirement for BTX injection to site(s) for disorders other than glabellar lines.
Known allergy or hypersensitivity to BTX.
Any medical condition or laboratory finding from central laboratory results.
The subject is unable and/or unwilling to comply fully with the protocol and the study.
Mental incapacity, unwillingness or language barriers.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

China10 sites

Peking University First Hospital
Beijing, 100034
Air Force General Hospital, PLA
Beijing, 100142
Peking Union Medical College Hospital
Beijing, 100730
Chinese PLA General Hospital
Beijing, 100853
The Third Xiangya Hospital of Central South University
Changsha, 410013
West China Hospital, Sichuan University
Chengdu, 610041
The Third Affiliated Hospital of Sun Yat-sen University
Guanzhou, 510630
Dermatology Hospital of the Chinese Academy of Medical Sciences
Nanjing, 210042
Tianjin Medical University General Hospital
Tianjing, 300052
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430022

Other trials in China

About this study

Official title: A Phase III, Randomised, Double Blind and Open Label Phase, Multicentre, Active and Placebo Controlled Study to Investigate the Efficacy and Safety of Dysport Including a Comparison to Botox in the Treatment of Moderate to Severe Glabellar Lines, and to Assess the Long Term Efficacy and Safety of Dysport Following Repeated Treatments in This Indication

Read the detailed description

The first treatment cycle will be double blind and subjects will be randomised to receive Dysport, Botox or placebo. After the first treatment cycle, all subjects will receive a maximum of four treatment cycles with Dysport, occurring at intervals of no less than 84 Days (12 weeks) between each treatment cycle, depending upon individual duration of response to Dysport treatment.

Conditions: Glabellar 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 (Dysport®)
Botulinum toxin type ABiological
Also called OnabotulinumtoxinA (Botox®)
PlaceboDrug
50 Units
PlaceboDrug
20 Units

Study groups in NCT02450526
Study group	Role	What they receive
AbobotulinumtoxinA	Experimental	Dysport, 50 Units, divided into five injections into the glabellar area. Administered in double blind fashion at cycle 1 followed by up to 4 cycles Dysport, 50 Units administered with an interval period depending on response, no less than 12 weeks between each treatment cycle. Receives: Biological: Botulinum toxin type A
OnabotulinumtoxinA	Active comparator	Botox will be administered in treatment cycle 1 only. On Day 1, 20 Units, divided into five injections into the glabellar area. Receives: Biological: Botulinum toxin type A
AbobotulinumtoxinA Placebo	Placebo comparator	Dysport placebo will be administered in treatment cycle 1 only. On Day 1, 50 Units, divided into five injections into the glabellar area. Receives: Drug: Placebo
OnabotulinumtoxinA Placebo	Placebo comparator	Botox placebo will be administered in treatment cycle 1 only. On Day 1, 20 Units, divided into five injections into the glabellar area. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Superiority Analysis of The Percentage of Responders Measured by the Investigator's Live Assessment (ILA) at Maximum Frown at Cycle 1, Day 29 (DB Period).
At baseline (Cycle 1, Day 1) and at Cycle 1, Day 29, the Investigator assessed the appearance of the glabellar lines at maximum frown using a validated 4-point Photographic Scale of Glabellar Line Severity. This 4-point scale rated the severity of glabellar lines as Grade 0 (none), Grade 1 (mild), Grade 2 (moderate) and Grade 3 (severe). A responder was defined as having a severity grade of 0 or 1 at Cycle 1, Day 29, and a severity grade of 2 or 3 at maximum frown at baseline.
Superiority analysis of active treatment versus placebo was carried out using a multivariate logistic regression model and adjusted for the stratification factors of gender and baseline severity score of glabellar lines at maximum frown measured by the ILA. The adjusted percentage of responders is presented for Cycle 1, Day 29.
Measured: At Cycle 1, Day 29.
Superiority Analysis of The Percentage of Responders Measured by the SSA at Maximum Frown at Cycle 1, Day 29 (DB Period).
At baseline (Cycle 1, Day 1) and at Cycle 1, Day 29, subjects assessed the appearance of their glabellar lines at maximum frown using a 4-point categorical scale. The 4-point scale represents the severity of glabellar lines as Grade 0 (no wrinkles), Grade 1 (mild wrinkles), Grade 2 (moderate wrinkles) and Grade 3 (severe wrinkles). For the SSA, a responder was defined as having a severity grade of 0 or 1 at maximum frown at Cycle 1, Day 29, and a severity grade of 2 or 3 at maximum frown at baseline.
Superiority analysis of active treatment versus placebo was carried out using a multivariate logistic regression model and adjusted for the stratification factors of gender and baseline severity score of glabellar lines at maximum frown measured by the ILA. The adjusted percentage of responders is presented for Cycle 1, Day 29.
Measured: At Cycle 1, Day 29.
Non-Inferiority Analysis of The Percentage of Responders Measured by the Investigator's Live Assessment (ILA) at Maximum Frown at Cycle 1, Day 29 (DB Period).
At baseline (Cycle 1, Day 1) and at Cycle 1, Day 29, the Investigator assessed the appearance of the glabellar lines at maximum frown using a validated 4-point Photographic Scale of Glabellar Line Severity. This 4-point scale rated the severity of glabellar lines as Grade 0 (none), Grade 1 (mild), Grade 2 (moderate) and Grade 3 (severe). A responder was defined as having a severity grade of 0 or 1 at Cycle 1, Day 29, and a severity grade of 2 or 3 at maximum frown at baseline.
Non Inferiority analysis of Dysport® versus Botox was carried out using a multivariate logistic regression model and adjusted for the stratification factors of gender and baseline severity score of glabellar lines at maximum frown measured by the ILA. The adjusted percentage of responders is presented for Cycle 1, Day 29.
Measured: At Cycle 1, Day 29.

Secondary outcomes (3)

The Percentage of Responders With Respect to Independent Reviewer's Assessment of Photographs of the Subject's Glabellar Lines at Maximum Frown at Cycle 1, Day 29 (DB Period).
Photographs of the glabellar region of subjects were taken at maximum frown at baseline (Cycle 1, Day 1) and at Cycle 1, Day 29. Photographs were assessed by an Independent Experts Committee using a validated 4-point Photographic Scale of Glabellar Line Severity which rated the severity of glabellar lines as Grade 0 (none), Grade 1 (mild), Grade 2 (moderate) and Grade 3 (severe). The median of three readings by three independent reviewers was used in the analysis. A responder was defined as having a severity grade of 0 or 1 at Cycle 1, Day 29, and a severity grade of 2 or 3 at baseline.
Superiority analysis of active treatment to placebo was carried out using a multivariate logistic regression model and adjusted for the stratification factors of gender and baseline severity score of glabellar lines at maximum frown measured by the ILA. The adjusted percentage of responders is presented for Cycle 1, Day 29.
Measured: At Cycle 1, Day 29.
Mean Subject's Global Assessment (SGA) Score at Cycle 1, Day 29 (DB Period).
On Cycle 1, Day 29, subjects were asked to assess the change, since the last treatment administration, in the appearance of their glabellar lines using the following 9-point Global Assessment Scale: +4 =100% improvement; +3 =75% improvement; +2 =50% improvement; +1 =25% improvement; 0 =no change; -1 =25% worsening; -2 =50%worsening; -3 =75% worsening; -4 =100% worsening.
The mean SGA score at Cycle 1, Day 29 is presented.
Measured: At Cycle 1, Day 29.
The Percentage of Responders With Respect to the SGA Score at Cycle 1, Day 29 (DB Period).
On Cycle 1, Day 29, subjects were asked to assess the change, since the last treatment administration, in the appearance of their glabellar lines using the following 9-point Global Assessment Scale: +4 =100% improvement; +3 =75% improvement; +2 =50% improvement; +1 =25% improvement; 0 =no change; -1 =25% worsening; -2 =50% worsening; -3 =75% worsening; -4 =100% worsening. A responder, based on the SGA scale, was defined as having a grade of at least +2 (50% improvement).
Superiority analysis of active treatment versus placebo was carried out using a multivariate logistic regression model and adjusted for the stratification factors of gender and baseline severity score of glabellar lines at maximum frown measured by the ILA. The adjusted percentage of responders is presented for Cycle 1, Day 29.
Measured: At Cycle 1, Day 29.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 20156 Sep 2017

First posted21 May 2015 (estimated)
Study startApr 2015
Primary completionJul 2016
Study completion6 Sep 2017

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 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 520 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02450526
Sponsor's protocol ID: Y-52-52120-158
Status last verified: Jul 2019
First submitted: 19 May 2015
Last updated: 6 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Study to Assess the Safety and Efficacy of Co-Reconstituted TrenibotulinumtoxinE and OnabotulinumtoxinA in Adult Participants With Moderate to Severe Upper Facial Lines
Upper Facial Lines, Glabellar Lines
Active, not recruitingPhase 1
A Study to Evaluate Sequential Administration of Injections of AGN-151586 Followed by BOTOX in Adult Participants for Treatment of Glabellar Lines
Glabellar Lines
RecruitingPhase 3
To Evaluate HU-045 With Moderate to Severe Glabellar Lines
Glabellar Lines
Active, not recruitingPhase 3
A Study to Assess the Effectiveness and Safety of IPN10200 Over Time in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
Moderate to Severe Glabellar Lines
RecruitingPhase 3
Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection to Treat Moderate to Severe Glabellar Lines
Moderate to Severe Glabellar Lines

All Glabellar Lines trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomised, Double Blind and Open Label Phase, Multicentre, Active and Placebo Controlled Study to Investigate the Efficacy and Safety of Dysport Including a Comparison to Botox in the Treatment of Moderate to Severe Glabellar Lines, and to Assess the Long Term Efficacy and Safety of Dysport Following Repeated Treatments in This Indication
ClinicalTrials.gov ID: NCT02450526
Acronym / sponsor ID: Y-52-52120-158
Conditions: Glabellar Lines
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 520 participants (actual)
Lead sponsor: IpsenIndustry (pharma, biotech, devices)
Study start: Apr 2015
Primary completion: Jul 2016 (actual)
Study completion: 6 Sep 2017 (actual)
First posted: 21 May 2015 (estimated)
Results: Posted 6 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
AbobotulinumtoxinA	Experimental	Biological: Botulinum toxin type ADysport, 50 Units, divided into five injections into the glabellar area. Administered in double blind fashion at cycle 1 followed by up to 4 cycles Dysport, 50 Units administered with an interval period depending on response, no less than 12 weeks between each treatment cycle.
OnabotulinumtoxinA	Active comparator	Biological: Botulinum toxin type ABotox will be administered in treatment cycle 1 only. On Day 1, 20 Units, divided into five injections into the glabellar area.
AbobotulinumtoxinA Placebo	Placebo comparator	Drug: PlaceboDysport placebo will be administered in treatment cycle 1 only. On Day 1, 50 Units, divided into five injections into the glabellar area.
OnabotulinumtoxinA Placebo	Placebo comparator	Drug: PlaceboBotox placebo will be administered in treatment cycle 1 only. On Day 1, 20 Units, divided into five injections into the glabellar area.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Provision of written informed consent
Male or female Chinese subjects who are between 18 to 65 years of age inclusive.
Have moderate or severe wrinkles of vertical glabellar lines (Grade 2 or 3) at maximum frown at baseline (Day 1), as assessed by the subject using SSA.
Have moderate or severe (Grade 2 or 3) vertical glabellar lines at maximum frown at baseline (Day 1), as assessed by the Investigator using ILA.
Be Botulinum Toxin (BTX) naïve or have received their most recent BTX-A treatment more than 1 year prior to screening.

Key exclusion criteria (19 listed)

Any prior surgery affecting corrugator supercilii, prior blepharoplasty or brow lift, dermal resurfacing, or any prior cosmetic procedures or scars within 36 months.
Any prior treatment with permanent fillers in the upper face.
Any prior treatment with nonpermanent dermal fillers in the upper face within the past 3 years and/or skin abrasions/resurfacing, photorejuvenation or skin/vascular laser intervention within the past 12 months.
Any planned facial cosmetic surgery or procedures during the study period.
Lack of capacity to frown.

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 (Dysport®)	Biological	AbobotulinumtoxinA
Botulinum toxin type AAlso: OnabotulinumtoxinA (Botox®)	Biological	OnabotulinumtoxinA
Placebo50 Units	Drug	AbobotulinumtoxinA Placebo
Placebo20 Units	Drug	OnabotulinumtoxinA Placebo

Primary outcome

Superiority Analysis of The Percentage of Responders Measured by the Investigator's Live Assessment (ILA) at Maximum Frown at Cycle 1, Day 29 (DB Period).
Time frame: At Cycle 1, Day 29.
At baseline (Cycle 1, Day 1) and at Cycle 1, Day 29, the Investigator assessed the appearance of the glabellar lines at maximum frown using a validated 4-point Photographic Scale of Glabellar Line Severity. This 4-point scale rated the severity of glabellar lines as Grade 0 (none), Grade 1 (mild), Grade 2 (moderate) and Grade 3 (severe). A responder was defined as having a severity grade of 0 or 1 at Cycle 1, Day 29, and a severity grade of 2 or 3 at maximum frown at baseline. Superiority analysis of active treatment versus placebo was carried out using a multivariate logistic regression model and adjusted for the stratification factors of gender and baseline severity score of glabellar lines at maximum frown measured by the ILA. The adjusted percentage of responders is presented for Cycle 1, Day 29.
Superiority Analysis of The Percentage of Responders Measured by the SSA at Maximum Frown at Cycle 1, Day 29 (DB Period).
Time frame: At Cycle 1, Day 29.
At baseline (Cycle 1, Day 1) and at Cycle 1, Day 29, subjects assessed the appearance of their glabellar lines at maximum frown using a 4-point categorical scale. The 4-point scale represents the severity of glabellar lines as Grade 0 (no wrinkles), Grade 1 (mild wrinkles), Grade 2 (moderate wrinkles) and Grade 3 (severe wrinkles). For the SSA, a responder was defined as having a severity grade of 0 or 1 at maximum frown at Cycle 1, Day 29, and a severity grade of 2 or 3 at maximum frown at baseline. Superiority analysis of active treatment versus placebo was carried out using a multivariate logistic regression model and adjusted for the stratification factors of gender and baseline severity score of glabellar lines at maximum frown measured by the ILA. The adjusted percentage of responders is presented for Cycle 1, Day 29.
Non-Inferiority Analysis of The Percentage of Responders Measured by the Investigator's Live Assessment (ILA) at Maximum Frown at Cycle 1, Day 29 (DB Period).
Time frame: At Cycle 1, Day 29.
At baseline (Cycle 1, Day 1) and at Cycle 1, Day 29, the Investigator assessed the appearance of the glabellar lines at maximum frown using a validated 4-point Photographic Scale of Glabellar Line Severity. This 4-point scale rated the severity of glabellar lines as Grade 0 (none), Grade 1 (mild), Grade 2 (moderate) and Grade 3 (severe). A responder was defined as having a severity grade of 0 or 1 at Cycle 1, Day 29, and a severity grade of 2 or 3 at maximum frown at baseline. Non Inferiority analysis of Dysport® versus Botox was carried out using a multivariate logistic regression model and adjusted for the stratification factors of gender and baseline severity score of glabellar lines at maximum frown measured by the ILA. The adjusted percentage of responders is presented for Cycle 1, Day 29.

3 secondary outcomes

The Percentage of Responders With Respect to Independent Reviewer's Assessment of Photographs of the Subject's Glabellar Lines at Maximum Frown at Cycle 1, Day 29 (DB Period).
Time frame: At Cycle 1, Day 29.
Mean Subject's Global Assessment (SGA) Score at Cycle 1, Day 29 (DB Period).
Time frame: At Cycle 1, Day 29.
The Percentage of Responders With Respect to the SGA Score at Cycle 1, Day 29 (DB Period).
Time frame: At Cycle 1, Day 29.

Results and safety

Results posted to the registry on 6 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dysport® 50 Units (U) - DB Period	325	294
Dysport® Placebo - DB Period	66	63
Botox 20 U - DB Period	107	97
Botox Placebo - DB Period	22	20
Dysport® 50 U - OL Period (Cycles 2-5)	0	0

Primary outcome: Superiority Analysis of The Percentage of Responders Measured by the Investigator's Live Assessment (ILA) at Maximum Frown at Cycle 1, Day 29 (DB Period).

Time frame: At Cycle 1, Day 29.. Number (95% Confidence Interval). Unit: adjusted percentage of responders

Measure	Dysport® 50 U - DB Period n = 294	Dysport® Placebo - DB Period n = 60	Botox 20 U - DB Period n = 94	Botox Placebo - DB Period n = 19
Value	95.2 (91.2 to 97.4)	0.9 (0.1 to 7.0)	94.0 (85.2 to 97.7)	4.3 (0.5 to 26.8)

Dysport® 50 U - DB Period vs Dysport® Placebo - DB Period: Treatment difference: 94.3 (95% CI 90.8 to 97.7), p <0.0001, Regression, Logistic

Population analysed: The modified Intent-to-treat (mITT) population was all randomised subjects who received study treatment in at least one injection site regardless of the amount administered and had both the baseline and Cycle 1, Day 29 assessments, for the ILA and subjects' self assessment (SSA) of glabellar lines at maximum frown.

Primary outcome: Superiority Analysis of The Percentage of Responders Measured by the SSA at Maximum Frown at Cycle 1, Day 29 (DB Period).

Time frame: At Cycle 1, Day 29.. Number (95% Confidence Interval). Unit: adjusted percentage of responders

Measure	Dysport® 50 U - DB Period n = 294	Dysport® Placebo - DB Period n = 60	Botox 20 U - DB Period n = 94	Botox Placebo - DB Period n = 19
Value	89.4 (84.4 to 93.0)	1.9 (0.4 to 8.4)	89.3 (79.2 to 94.9)	1.5 (0.1 to 21.0)

Dysport® 50 U - DB Period vs Dysport® Placebo - DB Period: Treatment difference: 87.5 (95% CI 82.5 to 92.4), p <0.0001, Regression, Logistic

Population analysed: The mITT population was all randomised subjects who received study treatment in at least one injection site regardless of the amount administered and had both the baseline and Cycle 1, Day 29 assessments, for the ILA and SSA of glabellar lines at maximum frown.

Primary outcome: Non-Inferiority Analysis of The Percentage of Responders Measured by the Investigator's Live Assessment (ILA) at Maximum Frown at Cycle 1, Day 29 (DB Period).

Time frame: At Cycle 1, Day 29.. Number (95% Confidence Interval). Unit: adjusted percentage of responders

Measure	Dysport® 50 U - DB Period n = 294	Botox 20 U - DB Period n = 94
Value	94.7 (90.8 to 96.9)	97.0 (92.0 to 98.9)

Dysport® 50 U - DB Period vs Botox 20 U - DB Period: Treatment Difference: -2.4 (95% CI -6.7 to 1.9)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment emergent adverse events (TEAEs) were defined as any adverse event with start date on or after the first injection of study treatment or with start date prior to the first injection of study treatment but the intensity increased after the first injection of study treatment. TEAEs were collected until the end of Cycle 5 of the OL period, over a total timeframe of up to approximately 29 months.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dysport® 50 U - DB Period	5 of 326 (1.5%)	83 of 326 (25.5%)	0 of 326
Dysport® Placebo - DB Period	2 of 66 (3%)	9 of 66 (13.6%)	0 of 66
Botox 20 U - DB Period	2 of 107 (1.9%)	23 of 107 (21.5%)	0 of 107
Botox Placebo - DB Period	0 of 21 (0%)	4 of 21 (19%)	0 of 21
Dysport® 50 U - OL Period	28 of 465 (6%)	142 of 465 (30.5%)	0 of 465

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Glabellar Lines

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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, M.D. study director

Ipsen

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Botulinum toxin type A in people with Glabellar Lines, run by Ipsen at 10 sites in China.

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 7 inclusion and 19 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 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 6 Jun 2019). 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?

Superiority Analysis of The Percentage of Responders Measured by the Investigator's Live Assessment (ILA) at Maximum Frown at Cycle 1, Day 29 (DB Period). (time frame: At Cycle 1, Day 29.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02450526.

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 6 Aug 2019.