Glabellar Frown LinesPhase 4NCT02096081
The Treatment of Glabellar Frown Lines
A Phase 4 study testing IncobotulinumtoxinA and OnabotulinumtoxinA in people with Glabellar Frown Lines, run by Merz North America, Inc. at 10 sites in United States.
Trial summary
The purpose of this study is to show that two FDA-approved botulinum toxin drugs called Xeomin® and Botox® can reduce the severity of vertical lines (wrinkles) that appear between the eyebrows (glabellar frown lines). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Glabellar Frown Lines
- What is being tested?
- IncobotulinumtoxinA and OnabotulinumtoxinA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 10 sitesUnited States
- Study dates
- Feb 2014to Nov 2014
- Phase
- Phase 4
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Outpatient females 18 to 50 years of age
- Moderate to severe glabellar frown lines
Who cannot join
- Glabellar Frown Lines at rest rating 3 on the 4-point Facial Wrinkle Scale
- Previous treatment with botulinum toxin
- Previous treatment with biodegradable fillers in glabellar area within last 12 months
- Any severe or uncontrolled systemic disease, malignant tumor, or medical history of HIV infection
- Known hypersensitivity to incobotulinumtoxinA or onabotulinumtoxinA or to any of their excipients
- Intake of any of the forbidden concomitant medication or other agents that might interfere with neuromuscular function or might interfere with the action of botulinum toxin type within 14 days prior to injection
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Merz Investigative Site #001098
Chestnut Hill, Massachusetts, 02467
Merz Investigative Site #001101
Coral Gables, Florida, 33146
Merz Investigative Site #001099
Los Angeles, California, 90069
Merz Investigative Site #001105
Metairie, Louisiana, 70006
Merz Investigative Site #001097
Nashville, Tennessee, 37215
Merz Investigative Site #001297
New York, New York, 10065
Merz Investigative Site #001300
Sacramento, California, 95819
Merz Investigative Site #001299
Santa Monica, California, 90404
Merz Investigative Site #001298
Washington D.C., District of Columbia, 20005
Merz Investigative Site #001170
Washington D.C., District of Columbia, 20037
About this study
The purpose of this study is to show that two FDA-approved botulinum toxin drugs called Xeomin® and Botox® can reduce the severity of vertical lines (wrinkles) that appear between the eyebrows (glabellar frown lines).
Read the detailed description
This is a prospective, multicenter, randomized, double-blind, parallel group clinical study to investigate the equivalence of incobotulinumtoxinA (Xeomin®) to onabotulinumtoxinA (Botox®) in the treatment of glabellar frown lines.
- Conditions
- Glabellar Frown Lines
- Being tested
- IncobotulinumtoxinA, OnabotulinumtoxinA
- Keywords
- Glabellar Frown Lines, Frown Lines, Facial Wrinkles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IncobotulinumtoxinADrug
Also called Xeomin®, NT201, Botulinum toxin type A [150 kDa], free from complexing proteins
20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection
OnabotulinumtoxinADrug
Also called Botox®
20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| IncobotulinumtoxinA | Experimental | 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points Receives: Drug: IncobotulinumtoxinA |
| OnabotulinumtoxinA | Active comparator | 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points Receives: Drug: OnabotulinumtoxinA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy, Measured as the Percentage of Participants Who Responded to Treatment
Response defined as ≥ 1 point improvement from baseline (prior to treatment) on the Facial Wrinkle Scale at maximum frown as rated by an independent masked panel of physicians specifically qualified to assess study photographs using subject photographs at 1 month from treatment.
Measured: 1 Month from baseline
Secondary outcomes (13)
Response at Maximum Frown Rated by Independent Rater
Response defined as ≥ 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by an independent masked panel of physicians specifically qualified to assess study photographs using subject photographs at 2 months from baseline.
Measured: 2 months from baseline
Response at Maximum Frown Rated by Independent Rater
Response defined as ≥ 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by an independent masked panel of physicians specifically qualified to assess study photographs using subject photographs at 3 months from baseline.
Measured: 3 months from baseline
Response at Maximum Frown Rated by Independent Rater
Response defined as ≥ 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by an independent masked panel of physicians specifically qualified to assess study photographs using subject photographs at 4 months from baseline.
Measured: 4 months from baseline
Response at Maximum Frown Rated by Treating Physician
Response defined as ≥ 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by the treating physicians using subject photographs at 1 month from treatment.
Measured: 1 month from baseline
Response at Maximum Frown Rated by Treating Physician
Response defined as ≥ 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by the treating physicians using subject photographs at 2 months from treatment.
Measured: 2 months from baseline
Response at Maximum Frown Rated by Treating Physician
Response defined as ≥ 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by the treating physicians using subject photographs at 3 months from treatment.
Measured: 3 months from baseline
Response at Maximum Frown Rated by Treating Physician
Response defined as ≥ 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by the treating physicians using subject photographs at 4 months from treatment.
Measured: 4 months from baseline
Subject Satisfaction
Assessment of subject treatment satisfaction by subject questionnaire and diary at 1 month from treatment. Extremely satisfied, satisfied, and slightly satisfied were categorized as "Satisfaction" and extremely dissatisfied, dissatisfied, and slightly dissatisfied were categorized as "Dissatisfaction." Subjects with missing data were categorized as "Missing."
Measured: 1 month from baseline
Subject Satisfaction
Assessment of subject treatment satisfaction by subject questionnaire and diary at 2 months from treatment. Extremely satisfied, satisfied, and slightly satisfied were categorized as "Satisfaction" and extremely dissatisfied, dissatisfied, and slightly dissatisfied were categorized as "Dissatisfaction." Subjects with missing data were categorized as "Missing."
Measured: 2 months from baseline
Subject Satisfaction
Assessment of subject treatment satisfaction by subject questionnaire and diary at 3 months from treatment. Extremely satisfied, satisfied, and slightly satisfied were categorized as "Satisfaction" and extremely dissatisfied, dissatisfied, and slightly dissatisfied were categorized as "Dissatisfaction." Subjects with missing data were categorized as "Missing."
Measured: 3 months from baseline
Subject Satisfaction
Assessment of subject treatment satisfaction by subject questionnaire and diary at 4 months from treatment. Extremely satisfied, satisfied, and slightly satisfied were categorized as "Satisfaction" and extremely dissatisfied, dissatisfied, and slightly dissatisfied were categorized as "Dissatisfaction." Subjects with missing data were categorized as "Missing."
Measured: 4 months from baseline
Subject Perception of Treatment Onset
Assessment of subject perception of date of treatment onset using a take-home diary
Measured: Open-ended time frame for the 4 month study duration. Data for onset and peak effect is recorded in the subject diary.
Subject Perception of Treatment Peak Effect
Assessment of subject perception of date of treatment peak effect using a take-home diary
Measured: Open-ended time frame for the 4 month study duration. Data for onset and peak effect is recorded in the subject diary.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2014
- Study completionNov 2014
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 Frown 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrea Schlӧbe, MD, Study director, Merz North America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096081
- Sponsor's protocol ID
- MUS 60201_4096_1
- Status last verified
- Sep 2017
- First submitted
- 20 Mar 2014
- Last updated
- 19 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kane MA, Gold MH, Coleman WP 3rd, Jones DH, Tanghetti EA, Alster TS, Rohrer TE, Burgess CM, Shamban AT, Finn E. A Randomized, Double-Blind Trial to Investigate the Equivalence of IncobotulinumtoxinA and OnabotulinumtoxinA for Glabellar Frown Lines. Dermatol Surg. 2015 Nov;41(11):1310-9. doi: 10.1097/DSS.0000000000000531.
PubMed 26509943
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment of Glabellar Frown Lines
- ClinicalTrials.gov ID
- NCT02096081
- Acronym / sponsor ID
- MUS 60201_4096_1
- Conditions
- Glabellar Frown Lines
- Keywords
- Glabellar Frown Lines, Frown Lines, Facial Wrinkles
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Posted 16 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to show that two FDA-approved botulinum toxin drugs called Xeomin® and Botox® can reduce the severity of vertical lines (wrinkles) that appear between the eyebrows (glabellar frown lines).
Detailed description
This is a prospective, multicenter, randomized, double-blind, parallel group clinical study to investigate the equivalence of incobotulinumtoxinA (Xeomin®) to onabotulinumtoxinA (Botox®) in the treatment of glabellar frown lines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IncobotulinumtoxinA | Experimental | Drug: IncobotulinumtoxinA20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points |
| OnabotulinumtoxinA | Active comparator | Drug: OnabotulinumtoxinA20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Outpatient females 18 to 50 years of age
- Moderate to severe glabellar frown lines
Key exclusion criteria (6 listed)
- Glabellar Frown Lines at rest rating 3 on the 4-point Facial Wrinkle Scale
- Previous treatment with botulinum toxin
- Previous treatment with biodegradable fillers in glabellar area within last 12 months
- Any severe or uncontrolled systemic disease, malignant tumor, or medical history of HIV infection
- Known hypersensitivity to incobotulinumtoxinA or onabotulinumtoxinA or to any of their excipients
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 |
|---|---|---|
| IncobotulinumtoxinAAlso: Xeomin®, NT201, Botulinum toxin type A [150 kDa], free from complexing proteins20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection | Drug | IncobotulinumtoxinA |
| OnabotulinumtoxinAAlso: Botox®20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection | Drug | OnabotulinumtoxinA |
Primary outcome
Efficacy, Measured as the Percentage of Participants Who Responded to Treatment
Time frame: 1 Month from baseline
Response defined as ≥ 1 point improvement from baseline (prior to treatment) on the Facial Wrinkle Scale at maximum frown as rated by an independent masked panel of physicians specifically qualified to assess study photographs using subject photographs at 1 month from treatment.
13 secondary outcomes
Response at Maximum Frown Rated by Independent Rater
Time frame: 2 months from baseline
Response at Maximum Frown Rated by Independent Rater
Time frame: 3 months from baseline
Response at Maximum Frown Rated by Independent Rater
Time frame: 4 months from baseline
Response at Maximum Frown Rated by Treating Physician
Time frame: 1 month from baseline
Response at Maximum Frown Rated by Treating Physician
Time frame: 2 months from baseline
Response at Maximum Frown Rated by Treating Physician
Time frame: 3 months from baseline
Response at Maximum Frown Rated by Treating Physician
Time frame: 4 months from baseline
Subject Satisfaction
Time frame: 1 month from baseline
Subject Satisfaction
Time frame: 2 months from baseline
Subject Satisfaction
Time frame: 3 months from baseline
Subject Satisfaction
Time frame: 4 months from baseline
Subject Perception of Treatment Onset
Time frame: Open-ended time frame for the 4 month study duration. Data for onset and peak effect is recorded in the subject diary.
Subject Perception of Treatment Peak Effect
Time frame: Open-ended time frame for the 4 month study duration. Data for onset and peak effect is recorded in the subject diary.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26509943Kane MA, Gold MH, Coleman WP 3rd, Jones DH, Tanghetti EA, Alster TS, Rohrer TE, Burgess CM, Shamban AT, Finn E. A Randomized, Double-Blind Trial to Investigate the Equivalence of IncobotulinumtoxinA and OnabotulinumtoxinA for Glabellar Frown Lines. Dermatol Surg. 2015 Nov;41(11):1310-9. doi: 10.1097/DSS.0000000000000531.
- Individual participant dataSharing planned: No
Related trials for Glabellar Frown Lines
RecruitingPhase 4
Head-to-Head Comparison of All Botulinum Neurotoxin Type A Products for Glabellar Rhytides
Wrinkle, Glabellar Frown Lines
Active, not recruitingEarly Phase 1
A Pilot Study Testing Onabotulinum Toxin A Versus Incobotulinum Toxin A Injections for Facial Wrinkles
Wrinkles
Active, not recruitingPhase 1
Depth of Botulinum Neurotoxin Injection for Treatment of Glabellar Lines
Glabellar Frown Lines
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.
Andrea Schlӧbe, MD study director
Merz North America, Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IncobotulinumtoxinA and OnabotulinumtoxinA in people with Glabellar Frown Lines, run by Merz North America, Inc. at 10 sites in United States.
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 6 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 19 Oct 2017. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 16 Mar 2017). 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?
Efficacy, Measured as the Percentage of Participants Who Responded to Treatment (time frame: 1 Month from baseline). 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 NCT02096081, 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 19 Oct 2017.