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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IncobotulinumtoxinA | Experimental | 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points |
|
| OnabotulinumtoxinA | Active Comparator | 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IncobotulinumtoxinA | Drug | 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 Month from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 months from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea SchlÓ§be, MD | Merz North America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merz Investigative Site #001099 | Los Angeles | California | 90069 | United States | ||
| Merz Investigative Site #001300 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26509943 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | IncobotulinumtoxinA | 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points. IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection |
| FG001 | OnabotulinumtoxinA | 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points. OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The safety evaluation set (SES) was used and is defined as the subset of all enrolled subjects who receive the study medication. Subjects in the SES were summarized according to the treatment they received and not by the treatment to which they were randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | IncobotulinumtoxinA | 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points. IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection |
| BG001 | OnabotulinumtoxinA |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All efficacy analyses were performed on the per protocol set (PPS) defined as the subset of subjects in the FAS for whom no major protocol deviations were identified. | Posted | Number | percentage of participants | 1 Month from baseline |
|
Adverse events were collected during the entire study period (4 months). Adverse events were not followed-up after the final study visit/safety visit, which was scheduled for 4 months post-treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IncobotulinumtoxinA | 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points. IncobotulinumtoxinA: 20U/injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Human ehrlichiosis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Widmann | Merz North America, Inc. | 919-582-8238 | Michelle.Widmann@merz.com |
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| ID | Term |
|---|---|
| C545476 | incobotulinumtoxinA |
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| OnabotulinumtoxinA | Drug | 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection |
|
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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." | 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." | 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." | 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." | 4 months from baseline |
| Subject Perception of Treatment Onset | Assessment of subject perception of date of treatment onset using a take-home diary | 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 | Open-ended time frame for the 4 month study duration. Data for onset and peak effect is recorded in the subject diary. |
| Sacramento |
| California |
| 95819 |
| United States |
| Merz Investigative Site #001299 | Santa Monica | California | 90404 | United States |
| Merz Investigative Site #001298 | Washington D.C. | District of Columbia | 20005 | United States |
| Merz Investigative Site #001170 | Washington D.C. | District of Columbia | 20037 | United States |
| Merz Investigative Site #001101 | Coral Gables | Florida | 33146 | United States |
| Merz Investigative Site #001105 | Metairie | Louisiana | 70006 | United States |
| Merz Investigative Site #001098 | Chestnut Hill | Massachusetts | 02467 | United States |
| Merz Investigative Site #001297 | New York | New York | 10065 | United States |
| Merz Investigative Site #001097 | Nashville | Tennessee | 37215 | United States |
20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points. OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | OnabotulinumtoxinA | 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points. OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection |
|
|
|
| Secondary | 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. | All efficacy analyses were performed on the per protocol set (PPS) defined as the subset of subjects in the FAS for whom no major protocol deviations were identified. | Posted | Number | percentage of participants | 2 months from baseline |
|
|
|
|
| Secondary | 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. | All efficacy analyses were performed on the per protocol set (PPS) defined as the subset of subjects in the FAS for whom no major protocol deviations were identified. | Posted | Number | percentage of participants | 3 months from baseline |
|
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| Secondary | 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. | All efficacy analyses were performed on the per protocol set (PPS) defined as the subset of subjects in the FAS for whom no major protocol deviations were identified. | Posted | Number | percentage of participants | 4 months from baseline |
|
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| Secondary | 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. | All efficacy analyses were performed on the per protocol set (PPS) defined as the subset of subjects in the FAS for whom no major protocol deviations were identified. | Posted | Number | percentage of participants | 1 month from baseline |
|
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|
|
| Secondary | 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. | All efficacy analyses were performed on the per protocol set (PPS) defined as the subset of subjects in the FAS for whom no major protocol deviations were identified. | Posted | Number | percentage of participants | 2 months from baseline |
|
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| Secondary | 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. | All efficacy analyses were performed on the per protocol set (PPS) defined as the subset of subjects in the FAS for whom no major protocol deviations were identified. | Posted | Number | percentage of participants | 3 months from baseline |
|
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| Secondary | 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. | All efficacy analyses were performed on the per protocol set (PPS) defined as the subset of subjects in the FAS for whom no major protocol deviations were identified. | Posted | Number | percentage of participants | 4 months from baseline |
|
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| Secondary | 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." | This endpoint was analyzed using observed cases in the per protocol set (PPS), defined as the subset of subjects in the FAS from whom no major protocol deviations were identified. | Posted | Number | participants | 1 month from baseline |
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| Secondary | 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." | This endpoint was analyzed using observed cases in the per protocol set (PPS), defined as the subset of subjects in the FAS from whom no major protocol deviations were identified. | Posted | Number | participants | 2 months from baseline |
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| Secondary | 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." | This endpoint was analyzed using observed cases in the per protocol set (PPS), defined as the subset of subjects in the FAS from whom no major protocol deviations were identified. | Posted | Number | participants | 3 months from baseline |
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| Secondary | 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." | This endpoint was analyzed using observed cases in the per protocol set (PPS), defined as the subset of subjects in the FAS from whom no major protocol deviations were identified. | Posted | Number | participants | 4 months from baseline |
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| Secondary | Subject Perception of Treatment Onset | Assessment of subject perception of date of treatment onset using a take-home diary | This endpoint was analyzed using observed cases in the per protocol set (PPS), defined as the subset of subjects in the FAS from whom no major protocol deviations were identified. | Posted | Median | Full Range | days | Open-ended time frame for the 4 month study duration. Data for onset and peak effect is recorded in the subject diary. |
|
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| Secondary | Subject Perception of Treatment Peak Effect | Assessment of subject perception of date of treatment peak effect using a take-home diary | This endpoint was analyzed using observed cases in the per protocol set (PPS), defined as the subset of subjects in the FAS from whom no major protocol deviations were identified. | Posted | Number | participants | Open-ended time frame for the 4 month study duration. Data for onset and peak effect is recorded in the subject diary. |
|
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| 1 |
| 122 |
| 9 |
| 122 |
| EG001 | OnabotulinumtoxinA | 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points. OnabotulinumtoxinA: 20U/injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection | 1 | 128 | 8 | 128 |
| Atypical pneumonia | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Facial Asymmetry | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
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| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| Missing |
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| Missing |
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| Missing |
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| Missing |
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| Missing |
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