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The purpose of this study is to assess the fields of anhydrotic effect (FAE) of abobotulinumtoxinA and onabotulinumtoxinA at the same labeled unit dose (1:1 units), comparing both sweat gland and muscle activity.
This is a prospective, single-center, randomized, double-blind study. All participants were recruited from a research center in Porto Alegre, Brazil, and provided written informed consent. The purpose of this study is to assess the fields of anhydrotic effect (FAE) of abobotulinumtoxinA and onabotulinumtoxinA at the same labeled unit dose (1:1 units), comparing both sweat gland and muscle activities. Nineteen patients were enrolled and evaluations were performed at baseline and 28 days after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| abobotulinumtoxin A | Active Comparator | Patients were randomized to the side of the forehead (left or right) in which the products were administered. All the patients received abobotulinumtoxin A in one of the sides of the forehead. |
|
| onabotulinumtoxin A | Active Comparator | Patients were randomized to the side of the forehead (left or right) in which the products were administered. All the patients received onabotulinumtoxin A in one of the sides of the forehead. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AbobotulinumtoxinA (ABO) | Drug | Isovolumetric (0.02 mL) doses of 2 units of abobotulinumtoxinA injected on one side of the forehead. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Horizontal Diameter of the Fields of Anhidrotic Effect | The Horizontal Diameter of the Fields of Anhidrotic Effect were measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ) The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The reaction of iodine and starch with the sweat (Minor's test) allows visualizing the field of anhidrotic effects and measuring them. The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FAE are observed at baseline. | 28 days |
| Vertical Diameter of the Fields of Anhidrotic Effect | The Vertical Diameter of the Fields of Anhidrotic Effect were measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ) The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The reaction of iodine and starch with the sweat (Minor's test) allows visualizing the field of anhidrotic effects and measuring them. The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FAE are observed at baseline. | 28 days |
| Area of the Fields of Anhidrotic Effect | The area of the Fields of Anhidrotic Effect were measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ) The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The reaction of iodine and starch with the sweat (Minor's test) allows visualizing the field of anhidrotic effects and measuring them. The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FAE are observed at baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Wrinkle Severity Scale (WSS) at Maximum Contraction | It is a 4-point validated scale for forehead lines: 0 - None
The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The muscular effect reduction can be observed by the reduction of facial lines. Wrinkle scales are used to grade the muscular effects of botulinum toxin. The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FME are observed at baseline. |
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Inclusion Criteria:
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Doris M Hexsel, MD | Brazilian Center for Studies in Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brazilian Center for Studies in Dermatology | Porto Alegre | Rio Grande do Sul | 90550-141 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24108521 | Derived | Hexsel D, Hexsel C, Siega C, Schilling-Souza J, Rotta FT, Rodrigues TC. Fields of effects of 2 commercial preparations of botulinum toxin type A at equal labeled unit doses: a double-blind randomized trial. JAMA Dermatol. 2013 Dec;149(12):1386-91. doi: 10.1001/jamadermatol.2013.6440. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A | Patients received 2U/0.02mL of reconstituted abobotulinumtoxinA on the right side of the forehead and 2U/0.02mL of reconstituted onabotulinumtoxinA on the left side. |
| FG001 | Group B | Patients received 2U/0.02mL of reconstituted abobotulinumtoxinA on the left side of the forehead and 2U/0.02mL of reconstituted onabotulinumtoxinA on the right side. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Split-face study. Each patient was treated with abobotulinumtoxin A in one side of the forehead, and with onabotulinumtoxin A on the contralateral side. Sides were randomized.
| ID | Title | Description |
|---|---|---|
| BG000 | Group A | Patients received 2U/0.02mL of reconstituted abobotulinumtoxinA on the right side of the forehead and 2U/0.02mL of reconstituted onabotulinumtoxinA on the left side. |
| BG001 | Group B |
| 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 | Horizontal Diameter of the Fields of Anhidrotic Effect | The Horizontal Diameter of the Fields of Anhidrotic Effect were measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ) The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The reaction of iodine and starch with the sweat (Minor's test) allows visualizing the field of anhidrotic effects and measuring them. The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FAE are observed at baseline. | Per protocol. | Posted | Mean | Standard Deviation | centimeters | 28 days |
|
28 days
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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 | Abobotulinumtoxin A | Patients were randomized to the side of the forehead (left or right) in which the products were administered. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment | Erythema after injection procedure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scientific Coordinator | Brazilian Center for Studies in Dermatology | +55 51 30262633 | cientifico@cbed.org.br |
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| ID | Term |
|---|---|
| C542869 | abobotulinumtoxinA |
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| OnabotulinumtoxinA (ONA) | Drug | Isovolumetric (0.02 mL) doses of 2 units of onabotulinumtoxinA injected on the other side of the forehead. |
|
|
| 28 days |
| Baseline and 28 days |
| Wrinkle Severity Scale (WSS) at Rest | It its a 4-point validated scale for forehead lines: 0 - None
The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The muscular effect reduction can be observed by the reduction of facial lines. Wrinkle scales are used to grade the muscular effects of botulinum toxin. The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FME are observed at baseline. | Baseline and 28 days |
| Evoked Compound Muscle Action Potentials (ECMAP) | Amplitude of the evoked compound muscle action potentials in the frontalis muscle on stimulation of the facial nerve performed at baseline and visit 2 using surface electrodes on the forehead and electrical stimulation of the facial nerve according to standard neurophysiologic procedures. The amplitude of the ECMAP was performed by an experienced neurologist using an electromyography device (Teca Sapphire; Teca Corp). | Baseline and 28 days |
Patients received 2U/0.02mL of reconstituted abobotulinumtoxinA on the left side of the forehead and 2U/0.02mL of reconstituted onabotulinumtoxinA on the right side.
| BG002 | Total | Total of all reporting groups |
| Sides of the forehead |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | Participants |
|
| OG001 | Onabotulinumtoxin A | Patients were randomized to the side of the forehead (left or right) in which the products were administered. |
|
|
| Primary | Vertical Diameter of the Fields of Anhidrotic Effect | The Vertical Diameter of the Fields of Anhidrotic Effect were measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ) The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The reaction of iodine and starch with the sweat (Minor's test) allows visualizing the field of anhidrotic effects and measuring them. The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FAE are observed at baseline. | Per protocol | Posted | Mean | Standard Deviation | centimeters | 28 days |
|
|
|
| Primary | Area of the Fields of Anhidrotic Effect | The area of the Fields of Anhidrotic Effect were measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ) The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The reaction of iodine and starch with the sweat (Minor's test) allows visualizing the field of anhidrotic effects and measuring them. The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FAE are observed at baseline. | Per protocol. | Posted | Mean | Standard Deviation | centimeters squared | 28 days |
|
|
|
| Secondary | Wrinkle Severity Scale (WSS) at Maximum Contraction | It is a 4-point validated scale for forehead lines: 0 - None
The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The muscular effect reduction can be observed by the reduction of facial lines. Wrinkle scales are used to grade the muscular effects of botulinum toxin. The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FME are observed at baseline. | Per protocol. | Posted | Number | participants | Baseline and 28 days |
|
|
|
| Secondary | Wrinkle Severity Scale (WSS) at Rest | It its a 4-point validated scale for forehead lines: 0 - None
The injection of botulinum toxin type A causes both muscle paralysis and anhydrosis on sweat glands activity. The size of the muscular and anhydrotic effects are called field of anhidrotic effects (FAE) and field of muscular effects (FME). The muscular effect reduction can be observed by the reduction of facial lines. Wrinkle scales are used to grade the muscular effects of botulinum toxin. The peak effect of botulinum toxin type A occurs between 15 and 30 days after injection. There is no change from the baseline, because no FME are observed at baseline. | Per protocol. | Posted | Number | participants | Baseline and 28 days |
|
|
|
| Secondary | Evoked Compound Muscle Action Potentials (ECMAP) | Amplitude of the evoked compound muscle action potentials in the frontalis muscle on stimulation of the facial nerve performed at baseline and visit 2 using surface electrodes on the forehead and electrical stimulation of the facial nerve according to standard neurophysiologic procedures. The amplitude of the ECMAP was performed by an experienced neurologist using an electromyography device (Teca Sapphire; Teca Corp). | Per protocol. | Posted | Mean | Standard Deviation | microvolts | Baseline and 28 days |
|
|
|
| 0 |
| 19 |
| 2 |
| 19 |
| EG001 | Onabotulinumtoxin A | Patients were randomized to the side of the forehead (left or right) in which the products were administered. | 0 | 19 | 1 | 19 |
|
| Bleeding | Skin and subcutaneous tissue disorders | Systematic Assessment | Minimal bleeding after injection procedure |
|
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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 |
| Baseline - Grade 2 |
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| Baseline - Grade 3 |
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| At 28 days - Grade 0 |
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| At 28 days - Grade 1 |
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| At 28 days - Grade 2 |
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| At 28 days - Grade 3 |
|
| Baseline - Grade 2 |
|
| Baseline - Grade 3 |
|
| At 28 days - Grade 0 |
|
| At 28 days - Grade 1 |
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| At 28 days - Grade 2 |
|
| At 28 days - Grade 3 |
|