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this study was proposed to provide more scientific and objective data on the clinical and aesthetic effects of these two toxins (Dysport and Xeomin).
Subjects will perform 6 (six) visits during the study:
Screening visit, performed 30 to 1 day before the visit 1, when eligible subjects will be recruited and first evaluations will be performed; visit 1, which is the baseline and when the injections will be performed; visit 2, 30 +/- 3 days after the injections, when evaluations will be performed; visit 3, 90 +/- 3 days after the injections, when evaluations will be performed; 4, 120 +/- 3 days after the injections, when evaluations will be performed; visit 5, 150 +/- 3 days after the injections, when evaluations will be performed.
Assessment of percentage (%) of responders, after 5 months of injection, to the effects of two BT-A preparations, Dysport® and Xeomin®, by measuring frontalis m. wrinkle intensity at maximum contraction, as measured by visual Wrinkles Severity Scale (WSS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dysport and Xeomin | Active Comparator | 30 U of Dysport® was injected on the right side of the forehead and 12 U Xeomin® was injected on the left side of the forehead (dose-equivalence 2.5:1). |
|
| Xeomin and Dysport | Active Comparator | 30 U Dysport® was injected on the left side of the forehead and 12 U Xeomin® was injected on the right side of the forehead (dose-equivalence 2.5:1). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dysport | Drug | Dysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders After 5 Months After the Procedure | Percentage (%) of responders, after 5 months of injection, to the effects of two botulinum toxin type A (BT-A), Dysport® and Xeomin®. Responders were defined as individuals who presented at least 1 score less in the Wrinkles Scale Score (WSS) at maximum contraction compared to the WSS score at baseline. WSS is a validated 4-point scale, at rest and at maximum voluntary contraction of the frontalis muscle, in which 0 means no wrinkles up to 3 which means sever wrinkles. | 5 months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Evoked Compound Muscle Action Potential | To evaluate the duration, magnitude and peak of effects of two BT-A preparations, by measuring of the maximum Evoked Compound Muscle Action Potentials after contraction. | 5 months after the procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Doris Hexsel, MD | Brazilian Center for Dermatologic Studies | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brazilian Center For Studies in Dermatology | Porto Alegre | Rio Grande do Sul | Brazil |
We did not have any drop-out in this study.
All patients included in this study were recruted from two research centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dysport and Xeomin | Dysport® was injected on the one side of the forehead and Xeomin® was injected on the other side of the forehead. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Xeomin and Dysport | Xeomin® was injected on the one side of the forehead and Dysport® was injected on the other side of the forehead. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Percentage of Responders After 5 Months After the Procedure | Percentage (%) of responders, after 5 months of injection, to the effects of two botulinum toxin type A (BT-A), Dysport® and Xeomin®. Responders were defined as individuals who presented at least 1 score less in the Wrinkles Scale Score (WSS) at maximum contraction compared to the WSS score at baseline. WSS is a validated 4-point scale, at rest and at maximum voluntary contraction of the frontalis muscle, in which 0 means no wrinkles up to 3 which means sever wrinkles. | 80 sujbects were included in this study, each patient have received both products in their faces. The randomization was performed to define the side for each product. | Posted | Number | percentage of participants | 5 months after intervention |
|
6 months
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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 | Dysport | Dysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening of Glabellar frown lines | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Worsening of Glabellar frown lines, transitory and related to the study medication. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Doris Hexsel | CBED | 30262633 | cbed@cbed.com.br |
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| ID | Term |
|---|---|
| C542869 | abobotulinumtoxinA |
| D019274 | Botulinum Toxins, Type A |
| C545476 | incobotulinumtoxinA |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
| Xeomin | Drug | Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead |
|
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Evoked Compound Muscle Action Potentials | The Evoked Compound Muscle Action Potentials (CMAP) is the sum of the action potentials of individual muscle fibers obtained by stimulating a motor nerve. It is obtained through a set surface electrode on the point of the motor muscle and a reference electrode placed on an electrically neutral area (usually on a tendon). The amplitude of the CMAP reflects the number of muscle fibers depolarized in response to a stimulus and is measured in millivolts (mV). | Mean | Standard Deviation | mV |
|
| OG001 | Xeomin | Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead. |
|
|
| Secondary | Maximum Evoked Compound Muscle Action Potential | To evaluate the duration, magnitude and peak of effects of two BT-A preparations, by measuring of the maximum Evoked Compound Muscle Action Potentials after contraction. | All subjects have received both treatments. | Posted | Mean | Standard Deviation | mV | 5 months after the procedure. |
|
|
|
| 0 |
| 80 |
| 2 |
| 80 |
| EG001 | Xeomin | Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead. | 0 | 80 | 2 | 80 |
|
| Injection site bleeding | Skin and subcutaneous tissue disorders | Systematic Assessment | Injection site bleeding, not related to the study medication. It was associated to the injection. |
|
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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 |