Glabellar LinesPhase 3NCT00512135

Safety and Efficacy of NT 201 (IncobotulinumtoxinA [Xeomin]) in the Treatment of Glabellar Frown Lines

A Phase 3 study testing IncobotulinumtoxinA (Xeomin) (20 units) in people with Glabellar Lines, run by Merz Pharmaceuticals GmbH at 25 sites in 3 countries.

Completed

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

Official record

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Trial summary

The study objective was to investigate the safety and efficacy of incobotulinumtoxinA (Xeomin) during repeat dose treatment of glabellar frown lines. 801 participants with moderate to severe glabellar frown lines at maximum frown who completed participation in one of the studies in this program, i.e. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glabellar Lines
What is being tested?: IncobotulinumtoxinA (Xeomin) (20 units)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 801 participants
Where: 25 sitesin 3 countries
Study dates: 18 Jun 2007to 28 Dec 2009
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants with 'moderate' or 'severe' glabellar frown lines at maximum frown at the beginning of each treatment cycle (as assessed by the investigator according to FWS) , stable medical condition; Completion of one former study in the Merz NT 201 glabellar program

Who cannot join

Participants with preexisting neuromuscular diseases (e.g. myasthenia gravis, Lambert-Eaton syndrome) putting the participant at risk, History of Facial Nerve Palsy, Previous treatment with Botulinum Toxin in the glabellar area during the last 12 months, Previous treatment with biodegradable fillers or other procedures (e.g. chemical peeling, photo rejuvenation) in the glabellar area during the last 12 months, Previous insertion of permanent material in the glabellar area; Planned treatment with Botulinum toxin of any serotype in any body region during the study period, Any other planned facial aesthetic procedure in the glabellar area during the trial period; Any surgery in the glabellar area including surgical removal of the corrugator, procerus or depressor supercili muscles or a combination of these or scars in the glabellar area, Inability to substantially lessen glabellar frown lines even by physically spreading apart, Marked facial asymmetry or ptosis of eyelid and/or eyebrow; Any infection in the area of the injection sites.

Trial locations and contacts

25 sites in 3 countries.

Country

City, postcode or hospital

25 sites in 3 countries

United States13 sites

Centre for Cosmetic Enhancement
Aventura, Florida, 33180
Laser &Skin Surgery Center of Indiana
Carmel, Indiana, 46032
Skin Care Physisians of Chestnut Hill
Chestnut Hill, Massachusetts, 02467
Brandt
Coral Gables, Florida, 33146
About Skin Dermatology
Englewood, Colorado, 80113
Advanced Dermatology Research Institute
Lincolnshire, Illinois, 60069
Skin Care Centre
Los Angeles, California, 90069
Coleman
Metairie, Louisiana, 70006
Image Dermatology P.C.
Montclair, New Jersey, 07042
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Schlessinger
Omaha, Nebraska, 68144
Flynn Consulting PLLC
Raleigh, North Carolina, 27608
Narins
White Plains, New York, 10604

Other trials in United States

Germany10 sites

Charité Berlin - Klinik für Dermatologie
Berlin, 10117
Rosenparkklinik
Darmstadt, 64297
Krankenhaus Dresden Friedrichstadt
Dresden, 01067
Johann-Wolfgang-Goethe- Universitätsklinikum Frankfurt
Frankfurt am Main, 60590
Universität Hamburg
Hamburg, 20146
SCIderm GmbH
Hamburg, 20354
Uniklinik Saarland
Homburg / Saar, 66421
Dr. Michael Sebastian
Mahlow, 15831
Dr. Hans-Ulrich Voigt
München, 80333
Dr. Thomas Dirschka
Wuppertal, 42275

Other trials in Germany

Canada2 sites

Solish
Toronto, Ontario, M5R3N8
Carruthers Dermatology Centre Inc.
Vancouver, British Columbia, V5Z4E1

Other trials in Canada

About this study

Official title: A Prospective, Open-label, Multicenter, Repeat-dose Trial to Investigate the Safety and Efficacy of NT 201, Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines

Read the detailed description

This was a prospective, multicenter, open-label, non-control group design Phase 3 clinical study. Approximately 880 participants who were to complete former studies in this program (370 participants from studies MRZ 60201-0520/1 (8) and MRZ 60201-0527/1 (8) as well as approximately 510 participants from studies MRZ 60201-0724/1 (10) and MRZ 60201-0741/1) (11) were expected to enroll in this study in 26 centers in the United States, Canada and Germany. Participants with moderate to severe glabellar frown lines at maximum frown who completed participation in one of these four "feeder" studies in the frown line program were eligible to participate in this repeated dose study. Each participant received a dose of 20 units incobotulinumtoxinA (Xeomin) intramuscular injection on Visit 1 (Day 0 of Cycle 1). Re-injections with 20 U NT 201 could be performed on Day 0 of a subsequent cycle for up to 8 cycles (one cycle >= 85 days). Intervals between treatments were at least three months or 12 weeks, i.e., >= 85 days. For a new treatment cycle to start, the participant had to request a re-injection. The investigator then had to assess if the glabellar frown lines had relapsed to 'moderate' or 'severe'. In this case, a new injection could be administered. The treatment duration per participant was 24 months and up to eight cycles for participants enrolled from studies MRZ 60201-0520/1 and MRZ 60201-0527/1 and 6 months and up to two cycles for participants enrolled from studies MRZ 60201-0724/1 and MRZ 60201-0741/1, respectively. Participants enrolled from studies MRZ 60201-0520/1 and MRZ 60201-0527/1 participated at least one year in the study whereas participants enrolled from studies MRZ 60201-0724/1 and MRZ 60201-0741/1 participated for six months and up to two cycles.

Conditions: Glabellar Lines
Being tested: IncobotulinumtoxinA (Xeomin) (20 units)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IncobotulinumtoxinA (Xeomin) (20 units)Drug
Also called IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins (20 units)
Injection of a total of 20 Units incobotulinumtoxinA (Xeomin) on day one of each of up to eight cycles, reconstituted in a total injection volume of 0.5 mL administered in five equal parts of 0.1 mL to five predefined points of the glabellar area.

Study groups in NCT00512135
Study group	Role	What they receive
IncobotulinumtoxinA (Xeomin) (20 units)	Experimental	IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin type A free from complexing proteins) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% sodium chloride (NaCl), 20 units, total volume 0.5 mL, mode of administration: intramuscular injection Receives: Drug: IncobotulinumtoxinA (Xeomin) (20 units)

What is being measured

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

Incidence of Adverse Events (AEs)
Measured: Baseline up to Month 30
Incidence of Adverse Events of Special Interest (AESI)
Measured: Baseline up to Month 30
Percentage of Responders at Maximum Frown as Assessed by the Investigator According to Facial Wrinkle Scale (FWS)
FWS was used to assess the severity of glabellar frown lines at maximum frown by the investigator. The 4-point scale depicted as: 0 = none, 1 = mild, 2 = moderate and 3 = severe. Responders on the FWS were defined as participants with glabellar line severity of none (0) or mild (1).
Measured: At evaluation visit (30 days after injection) and at last control visit (85 days after last injection) in each treatment cycle from Cycle 1 to Cycle 8 (each cycle length >=85 days)
Percentage of Responders at Rest as Assessed by the Investigator According to FWS
FWS was used to assess the severity of glabellar frown lines at rest by the investigator. The 4-point scale depicted as: 0 = none, 1 = mild, 2 = moderate and 3 = severe. Responders on the FWS were defined as participants with glabellar line severity of none (0) or mild (1). Responders on the FWS were defined as participants with glabellar line severity of none (0) or mild (1).
Measured: At evaluation visit (30 days after injection) and at last control visit (85 days after last injection) in each treatment cycle from Cycle 1 to Cycle 8 (each cycle length >=85 days)
Percentage of Responders at Maximum Frown by Participant's Assessment on the 4-point Scale
Participant's assessment of the glabellar frown lines at maximum frown on the 4-point scale was done by asking participant the following question in local language: "How would you judge the potency of frown muscle action by comparison to sample photos at this visit?" The possible rating responses were: 0 = no muscle action at all, 1 = some even slight muscle action possible, 2 = moderately strong muscle action possible, 3 = strong muscle action possible which may cause local pallor. Responders were participants with at least 1-point improvement compared to Day 0 whereas improvement was expressed by lowering of the numerical score.
Measured: At evaluation visit (30 days after injection) and at last control visit (85 days after last injection) in each treatment cycle from Cycle 1 to Cycle 8 (each cycle length >=85 days)
Percentage of Responders at Rest by Participant's Assessment on the 4-point Scale
Participant's assessment of the glabellar frown lines at rest on the 4-point scale was done by asking participant the following question in local language: "How would you judge the degree of your glabellar lines by comparison to sample photos at this visit?" The possible rating responses were: 0 = no visible vertical line(s) at all, 1 = slightly visible vertical line(s), 2 = moderate vertical line(s) with depression, and 3 = deep vertical line(s) and depression which cannot be effaced by spreading. Responders were participants with at least 1-point improvement compared to Day 0 whereas improvement was expressed by lowering of the numerical score.
Measured: At evaluation visit (30 days after injection) and at last control visit (85 days after last injection) in each treatment cycle from Cycle 1 to Cycle 8 (each cycle length >=85 days)
Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown
Number of participants are reported categorized in grades based on the assessment of the glabellar frown lines at maximum frown on the 6-point Likert scale. Participant's assessment of the glabellar frown lines at maximum frown on the 6-point Likert type scale was done by asking participant the following question in local language: "How would you judge the potency of frown muscle action at this visit?" The possible rating responses were given on a categorical scale of 6 grades between the grades 0 = none at all and 5 = very deep, with higher score reflecting higher potency.
Measured: At evaluation visit (30 days after injection); and at last control visit (85 days after last injection) in each treatment cycle from Cycle 1 to Cycle 8 (each cycle length >=85 days)
Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest
Number of participants are reported categorized in grades based on the assessment of the glabellar frown lines at rest on the 6-point Likert scale. Participant's assessment of the glabellar frown lines at rest on the 6-point Likert type scale was done by asking participant the following question in local language: "How would you judge the degree of your glabellar lines at this visit?" The possible rating responses were given on a categorical scale of 6 grades between the grades 0 = none at all and 5 = very deep, with higher scores reflecting higher degree of glabellar lines.
Measured: At evaluation visit (30 days after injection); and at last control visit (85 days after last injection) in each treatment cycle from Cycle 1 to Cycle 8 (each cycle length >=85 days)
Time to Onset of Treatment Effect
Onset of treatment effect was analyzed using number of participants with corresponding onset of treatment effect, stratified by cycles.
Measured: From injection visit up to date of onset of treatment effect in each treatment cycle from Cycle 1 to Cycle 8 (each cycle length >=85 days)

Timeline

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

18 Jun 200728 Dec 2009

First posted7 Aug 2007 (estimated)
Study start18 Jun 2007
Primary completion28 Dec 2009
Study completion28 Dec 2009

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Glabellar LinesStudies of the same condition, open and under way.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 801 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00512135
Sponsor's protocol ID: MRZ 60201-0609/1
Other IDs: 2006-005342-36
Status last verified: Mar 2021
First submitted: 6 Aug 2007
Last updated: 2 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Rzany B, Flynn TC, Schlobe A, Heinz M, Harrington L. Long-term results for incobotulinumtoxinA in the treatment of glabellar frown lines. Dermatol Surg. 2013 Jan;39(1 Pt 1):95-103. doi: 10.1111/dsu.12008. Epub 2012 Nov 27.
PubMed 23190342

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

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All Glabellar Lines trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Open-label, Multicenter, Repeat-dose Trial to Investigate the Safety and Efficacy of NT 201, Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines
ClinicalTrials.gov ID: NCT00512135
Acronym / sponsor ID: MRZ 60201-0609/1
Conditions: Glabellar Lines
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 801 participants (actual)
Lead sponsor: Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
Study start: 18 Jun 2007 (actual)
Primary completion: 28 Dec 2009 (actual)
Study completion: 28 Dec 2009 (actual)
First posted: 7 Aug 2007 (estimated)
Results: Posted 2 Apr 2021

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
IncobotulinumtoxinA (Xeomin) (20 units)	Experimental	Drug: IncobotulinumtoxinA (Xeomin) (20 units)IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin type A free from complexing proteins) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% sodium chloride (NaCl), 20 units, total volume 0.5 mL, mode of administration: intramuscular injection

Who may qualify

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

Key inclusion criteria (1 listed)

Participants with 'moderate' or 'severe' glabellar frown lines at maximum frown at the beginning of each treatment cycle (as assessed by the investigator according to FWS) , stable medical condition; Completion of one former study in the Merz NT 201 glabellar program

Key exclusion criteria (1 listed)

Participants with preexisting neuromuscular diseases (e.g. myasthenia gravis, Lambert-Eaton syndrome) putting the participant at risk, History of Facial Nerve Palsy, Previous treatment with Botulinum Toxin in the glabellar area during the last 12 months, Previous treatment with biodegradable fillers or other procedures (e.g. chemical peeling, photo rejuvenation) in the glabellar area during the last 12 months, Previous insertion of permanent material in the glabellar area; Planned treatment with Botulinum toxin of any serotype in any body region during the study period, Any other planned facial aesthetic procedure in the glabellar area during the trial period; Any surgery in the glabellar area including surgical removal of the corrugator, procerus or depressor supercili muscles or a combination of these or scars in the glabellar area, Inability to substantially lessen glabellar frown lines even by physically spreading apart, Marked facial asymmetry or ptosis of eyelid and/or eyebrow; Any infection in the area of the injection sites.

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
IncobotulinumtoxinA (Xeomin) (20 units)Also: IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins (20 units)Injection of a total of 20 Units incobotulinumtoxinA (Xeomin) on day one of each of up to eight cycles, reconstituted in a total injection volume of 0.5 mL administered in five equal parts of 0.1 mL to five predefined points of the glabellar area.	Drug	IncobotulinumtoxinA (Xeomin) (20 units)

Primary outcome

Incidence of Adverse Events (AEs)
Time frame: Baseline up to Month 30
Incidence of Adverse Events of Special Interest (AESI)
Time frame: Baseline up to Month 30
Percentage of Responders at Maximum Frown as Assessed by the Investigator According to Facial Wrinkle Scale (FWS)
Time frame: At evaluation visit (30 days after injection) and at last control visit (85 days after last injection) in each treatment cycle from Cycle 1 to Cycle 8 (each cycle length >=85 days)
FWS was used to assess the severity of glabellar frown lines at maximum frown by the investigator. The 4-point scale depicted as: 0 = none, 1 = mild, 2 = moderate and 3 = severe. Responders on the FWS were defined as participants with glabellar line severity of none (0) or mild (1).
Percentage of Responders at Rest as Assessed by the Investigator According to FWS
Time frame: At evaluation visit (30 days after injection) and at last control visit (85 days after last injection) in each treatment cycle from Cycle 1 to Cycle 8 (each cycle length >=85 days)
FWS was used to assess the severity of glabellar frown lines at rest by the investigator. The 4-point scale depicted as: 0 = none, 1 = mild, 2 = moderate and 3 = severe. Responders on the FWS were defined as participants with glabellar line severity of none (0) or mild (1). Responders on the FWS were defined as participants with glabellar line severity of none (0) or mild (1).
Percentage of Responders at Maximum Frown by Participant's Assessment on the 4-point Scale
Time frame: At evaluation visit (30 days after injection) and at last control visit (85 days after last injection) in each treatment cycle from Cycle 1 to Cycle 8 (each cycle length >=85 days)
Participant's assessment of the glabellar frown lines at maximum frown on the 4-point scale was done by asking participant the following question in local language: "How would you judge the potency of frown muscle action by comparison to sample photos at this visit?" The possible rating responses were: 0 = no muscle action at all, 1 = some even slight muscle action possible, 2 = moderately strong muscle action possible, 3 = strong muscle action possible which may cause local pallor. Responders were participants with at least 1-point improvement compared to Day 0 whereas improvement was expressed by lowering of the numerical score.
Percentage of Responders at Rest by Participant's Assessment on the 4-point Scale
Time frame: At evaluation visit (30 days after injection) and at last control visit (85 days after last injection) in each treatment cycle from Cycle 1 to Cycle 8 (each cycle length >=85 days)
Participant's assessment of the glabellar frown lines at rest on the 4-point scale was done by asking participant the following question in local language: "How would you judge the degree of your glabellar lines by comparison to sample photos at this visit?" The possible rating responses were: 0 = no visible vertical line(s) at all, 1 = slightly visible vertical line(s), 2 = moderate vertical line(s) with depression, and 3 = deep vertical line(s) and depression which cannot be effaced by spreading. Responders were participants with at least 1-point improvement compared to Day 0 whereas improvement was expressed by lowering of the numerical score.
Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Maximum Frown
Time frame: At evaluation visit (30 days after injection); and at last control visit (85 days after last injection) in each treatment cycle from Cycle 1 to Cycle 8 (each cycle length >=85 days)
Number of participants are reported categorized in grades based on the assessment of the glabellar frown lines at maximum frown on the 6-point Likert scale. Participant's assessment of the glabellar frown lines at maximum frown on the 6-point Likert type scale was done by asking participant the following question in local language: "How would you judge the potency of frown muscle action at this visit?" The possible rating responses were given on a categorical scale of 6 grades between the grades 0 = none at all and 5 = very deep, with higher score reflecting higher potency.
Degree of Glabellar Lines as Assessed by the Participant on the 6-point Likert Type Scale at Rest
Time frame: At evaluation visit (30 days after injection); and at last control visit (85 days after last injection) in each treatment cycle from Cycle 1 to Cycle 8 (each cycle length >=85 days)
Number of participants are reported categorized in grades based on the assessment of the glabellar frown lines at rest on the 6-point Likert scale. Participant's assessment of the glabellar frown lines at rest on the 6-point Likert type scale was done by asking participant the following question in local language: "How would you judge the degree of your glabellar lines at this visit?" The possible rating responses were given on a categorical scale of 6 grades between the grades 0 = none at all and 5 = very deep, with higher scores reflecting higher degree of glabellar lines.
Time to Onset of Treatment Effect
Time frame: From injection visit up to date of onset of treatment effect in each treatment cycle from Cycle 1 to Cycle 8 (each cycle length >=85 days)
Onset of treatment effect was analyzed using number of participants with corresponding onset of treatment effect, stratified by cycles.

Results and safety

Results posted to the registry on 2 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IncobotulinumtoxinA 20 U	801	717

Primary outcome: Incidence of Adverse Events (AEs)

Time frame: Baseline up to Month 30. Count of participants. Unit: Participants

Measure	IncobotulinumtoxinA 20 U n = 796
Value	374

Population analysed: The FAS consisted of all participants who were successfully screened for the study (signed the ICF) and received at least one injection of the study drug.

Primary outcome: Incidence of Adverse Events of Special Interest (AESI)

Time frame: Baseline up to Month 30. Count of participants. Unit: Participants

Measure	IncobotulinumtoxinA 20 U n = 796
Value	9

Population analysed: The FAS consisted of all participants who were successfully screened for the study (signed the ICF) and received at least one injection of the study drug.

Primary outcome: Percentage of Responders at Maximum Frown as Assessed by the Investigator According to Facial Wrinkle Scale (FWS)

Time frame: At evaluation visit (30 days after injection) and at last control visit (85 days after last injection) in each treatment cycle from Cycle 1 to Cycle 8 (each cycle length >=85 days). Number (95% Confidence Interval). Unit: percentage of participants

Measure	IncobotulinumtoxinA 20 U n = 796
Cycle 1: Evaluation Visit	79.1 (76.2 to 81.8)
Cycle 2: Evaluation Visit	79.8 (76.7 to 82.6)
Cycle 3: Evaluation Visit	80.1 (75.4 to 84.1)
Cycle 4: Evaluation Visit	80.3 (75.5 to 84.3)
Cycle 5: Evaluation Visit	81.4 (76.6 to 85.5)
Cycle 6: Evaluation Visit	81.2 (76.0 to 85.5)
Cycle 7: Evaluation Visit	82.7 (76.7 to 87.4)
Cycle 8: Evaluation Visit	89.6 (77.8 to 95.5)

Population analysed: The FAS consisted of all participants who were successfully screened for the study (signed the ICF) and received at least one injection of the study drug. Here number analyzed "n" were the participants who were evaluable for this outcome measure at given time points.

Primary outcome: Percentage of Responders at Rest as Assessed by the Investigator According to FWS

Measure	IncobotulinumtoxinA 20 U n = 796
Cycle 1: Evaluation Visit	78.9 (75.9 to 81.6)
Cycle 2: Evaluation Visit	79.7 (76.5 to 82.5)
Cycle 3: Evaluation Visit	80.7 (76.1 to 84.7)
Cycle 4: Evaluation Visit	80.6 (75.8 to 84.6)
Cycle 5: Evaluation Visit	79.4 (74.4 to 83.6)
Cycle 6: Evaluation Visit	77.0 (71.5 to 81.7)
Cycle 7: Evaluation Visit	81.2 (75.0 to 86.1)
Cycle 8: Evaluation Visit	87.5 (75.3 to 94.1)

Adverse events

Time frame: Baseline up to Month 30. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IncobotulinumtoxinA 20 U	29 of 796 (3.6%)	169 of 796 (21.2%)	0 of 796

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23190342Rzany B, Flynn TC, Schlobe A, Heinz M, Harrington L. Long-term results for incobotulinumtoxinA in the treatment of glabellar frown lines. Dermatol Surg. 2013 Jan;39(1 Pt 1):95-103. doi: 10.1111/dsu.12008. Epub 2012 Nov 27.

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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.

Berthold Rzany, Prof. Dr. med Sc.M. principal investigator

Division of Evidence Based Medicine dEBM, Department of Dermatology, Venerology and Allergology , Charité - University Medicine, Berlin, Germany

Timothy Corcoran Flynn, MD principal investigator

25 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IncobotulinumtoxinA (Xeomin) (20 units) in people with Glabellar Lines, run by Merz Pharmaceuticals GmbH at 25 sites in 3 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 1 inclusion and 1 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 2 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States, Germany, Canada. 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. 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 2 Apr 2021). 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?

Incidence of Adverse Events (AEs) (time frame: Baseline up to Month 30). The study lists 9 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 NCT00512135, which also lists 1 linked publication.

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 2 Apr 2021.