Trial Outcomes & Findings for Fields Of Effects Of Two Commercial Preparations Of Botulinum Toxin Type A At Equal Labeled Unit Doses (NCT NCT01732809)

NCT ID: NCT01732809

Last Updated: 2020-12-17

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 19 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2020-12-17

Participant Flow

Unit of analysis: sides of the forehead

Participant milestones

Measure	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.	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.
Overall Study STARTED	9 18	10 20
Overall Study COMPLETED	9 18	9 18
Overall Study NOT COMPLETED	0 0	1 2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fields Of Effects Of Two Commercial Preparations Of Botulinum Toxin Type A At Equal Labeled Unit Doses

Baseline characteristics by cohort

Measure	Group A n=18 Sides of the forehead 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.	Group B n=20 Sides of the forehead 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.	Total n=38 Sides of the forehead Total of all reporting groups
Age, Continuous	42.7 years STANDARD_DEVIATION 10.6 • n=93 Participants	35.7 years STANDARD_DEVIATION 9.1 • n=4 Participants	39.0 years STANDARD_DEVIATION 10.2 • n=27 Participants
Sex: Female, Male Female	9 Participants n=93 Participants	10 Participants n=4 Participants	19 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	9 Participants n=93 Participants	10 Participants n=4 Participants	19 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment Brazil	9 Participants n=93 Participants	10 Participants n=4 Participants	19 Participants n=27 Participants

PRIMARY outcome

Timeframe: 28 days

Population: Per protocol.

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.

Outcome measures

Measure	Abobotulinumtoxin A n=18 Participants Patients were randomized to the side of the forehead (left or right) in which the products were administered.	Onabotulinumtoxin A n=18 Participants Patients were randomized to the side of the forehead (left or right) in which the products were administered.
Horizontal Diameter of the Fields of Anhidrotic Effect	0.84 centimeters Standard Deviation 0.14	1.24 centimeters Standard Deviation 0.24

PRIMARY outcome

Timeframe: 28 days

Population: Per protocol

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.

Outcome measures

Measure	Abobotulinumtoxin A n=18 Participants Patients were randomized to the side of the forehead (left or right) in which the products were administered.	Onabotulinumtoxin A n=18 Participants Patients were randomized to the side of the forehead (left or right) in which the products were administered.
Vertical Diameter of the Fields of Anhidrotic Effect	1.19 centimeters Standard Deviation 0.19	1.50 centimeters Standard Deviation 0.26

PRIMARY outcome

Timeframe: 28 days

Population: Per protocol.

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.

Outcome measures

Measure	Abobotulinumtoxin A n=18 Participants Patients were randomized to the side of the forehead (left or right) in which the products were administered.	Onabotulinumtoxin A n=18 Participants Patients were randomized to the side of the forehead (left or right) in which the products were administered.
Area of the Fields of Anhidrotic Effect	0.86 centimeters squared Standard Deviation 0.22	1.49 centimeters squared Standard Deviation 0.49

SECONDARY outcome

Timeframe: Baseline and 28 days

Population: Per protocol.

It is a 4-point validated scale for forehead lines:

0 - None

1. - Mild

2. - Moderate

3. - Severe

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.

Outcome measures

Measure	Abobotulinumtoxin A n=18 Participants Patients were randomized to the side of the forehead (left or right) in which the products were administered.	Onabotulinumtoxin A n=18 Participants Patients were randomized to the side of the forehead (left or right) in which the products were administered.
Wrinkle Severity Scale (WSS) at Maximum Contraction Baseline - Grade 0	0 participants	0 participants
Wrinkle Severity Scale (WSS) at Maximum Contraction Baseline - Grade 1	0 participants	0 participants
Wrinkle Severity Scale (WSS) at Maximum Contraction Baseline - Grade 2	7 participants	6 participants
Wrinkle Severity Scale (WSS) at Maximum Contraction Baseline - Grade 3	11 participants	12 participants
Wrinkle Severity Scale (WSS) at Maximum Contraction At 28 days - Grade 0	5 participants	6 participants
Wrinkle Severity Scale (WSS) at Maximum Contraction At 28 days - Grade 1	10 participants	8 participants
Wrinkle Severity Scale (WSS) at Maximum Contraction At 28 days - Grade 2	2 participants	3 participants
Wrinkle Severity Scale (WSS) at Maximum Contraction At 28 days - Grade 3	1 participants	1 participants

SECONDARY outcome

Timeframe: Baseline and 28 days

Population: Per protocol.

It its a 4-point validated scale for forehead lines:

0 - None

1. - Mild

2. - Moderate

3. - Severe

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.

Outcome measures

Measure	Abobotulinumtoxin A n=18 Participants Patients were randomized to the side of the forehead (left or right) in which the products were administered.	Onabotulinumtoxin A n=18 Participants Patients were randomized to the side of the forehead (left or right) in which the products were administered.
Wrinkle Severity Scale (WSS) at Rest Baseline - Grade 0	1 participants	1 participants
Wrinkle Severity Scale (WSS) at Rest Baseline - Grade 1	8 participants	7 participants
Wrinkle Severity Scale (WSS) at Rest Baseline - Grade 2	4 participants	5 participants
Wrinkle Severity Scale (WSS) at Rest Baseline - Grade 3	5 participants	5 participants
Wrinkle Severity Scale (WSS) at Rest At 28 days - Grade 0	10 participants	10 participants
Wrinkle Severity Scale (WSS) at Rest At 28 days - Grade 1	6 participants	6 participants
Wrinkle Severity Scale (WSS) at Rest At 28 days - Grade 2	2 participants	2 participants
Wrinkle Severity Scale (WSS) at Rest At 28 days - Grade 3	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline and 28 days

Population: Per protocol.

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).

Outcome measures

Measure	Abobotulinumtoxin A n=18 Participants Patients were randomized to the side of the forehead (left or right) in which the products were administered.	Onabotulinumtoxin A n=18 Participants Patients were randomized to the side of the forehead (left or right) in which the products were administered.
Evoked Compound Muscle Action Potentials (ECMAP) Baseline	1108.17 microvolts Standard Deviation 364.76	1079.11 microvolts Standard Deviation 266.02
Evoked Compound Muscle Action Potentials (ECMAP) Day 28	202.89 microvolts Standard Deviation 258.44	165.39 microvolts Standard Deviation 232.10

Adverse Events

Abobotulinumtoxin A

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Onabotulinumtoxin A

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Abobotulinumtoxin A n=19 participants at risk Patients were randomized to the side of the forehead (left or right) in which the products were administered.	Onabotulinumtoxin A n=19 participants at risk Patients were randomized to the side of the forehead (left or right) in which the products were administered.
Skin and subcutaneous tissue disorders Erythema	5.3% 1/19 • Number of events 1 • 28 days	5.3% 1/19 • Number of events 1 • 28 days
Skin and subcutaneous tissue disorders Bleeding	10.5% 2/19 • Number of events 2 • 28 days	5.3% 1/19 • Number of events 1 • 28 days

Additional Information

Scientific Coordinator

Brazilian Center for Studies in Dermatology

Phone: +55 51 30262633

Email: cientifico@cbed.org.br

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place