Trial Outcomes & Findings for Field of Effects of Two Commercial Preparations of Botulinum Toxin Type A (NCT NCT00989768)

Results Overview

The colorful complex formed by Minor's test allows the visualization of the area covered by the effects of botulinum toxin on sweat glands, also known as action halos. The horizontal diameter at day 28 were expressed in centimeters and quantified by the software Mirror® (Canfield Scientific Inc., USA).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

29 participants

Primary outcome timeframe

28 Days

Results posted on

2010-06-02

Participant Flow

A total of 29 subjects was recruited at Brazilian Center For Studies in Dermatology, in Porto Alegre, Brazil. The anticipated drop out rate is 10%. Participants were their own control, because on one side of frontal region they have received 5U of botulinum toxin - Dysport and on other side 4U of botulinum toxin - Botox;

13 volunteers were excluded; Screen failure: Iodine allergy = 2; Minor´s Test failure = 6 Mild wrinkles = 3 Inclusion criteria failure = 2 Minor's test allows the visualization of the area covered by the effects of botulinum toxin on sweat glands also known as action halos.

Participant milestones

Participant milestones
Measure	Dysport® 5U/ Botox® 2U Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region, that the other brand Botox® was administered two units to the other side of the frontal region.
Overall Study STARTED	29
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Field of Effects of Two Commercial Preparations of Botulinum Toxin Type A

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dysport® 5U/ Botox® 2U n=29 Participants Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region, that the other brand Botox® was administered two units to the other side of the frontal region.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 28 Days

The colorful complex formed by Minor's test allows the visualization of the area covered by the effects of botulinum toxin on sweat glands, also known as action halos. The horizontal diameter at day 28 were expressed in centimeters and quantified by the software Mirror® (Canfield Scientific Inc., USA).

Outcome measures

Outcome measures
Measure	Dysport® 5U n=28 Participants Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region.	Botox® 2U n=28 Participants Two units of Botox® was administered to the other side of the frontal region.
Horizontal Action Halo Diameter at 28 Days	1.28 centimeter Standard Deviation 0.26	1.12 centimeter Standard Deviation 0.31

PRIMARY outcome

Timeframe: 112 days

The colorful complex formed by Minor's test allows the visualization of the area covered by the effects of botulinum toxin on sweat glands, also known as action halos. The horizontal diameter at day 112 were expressed in centimeters and quantified by the software Mirror® (Canfield Scientific Inc., USA).

Outcome measures

Outcome measures
Measure	Dysport® 5U n=28 Participants Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region.	Botox® 2U n=28 Participants Two units of Botox® was administered to the other side of the frontal region.
Horizontal Action Halo Diameter at 112 Days	1.12 centimeter Standard Deviation 0.26	0.96 centimeter Standard Deviation 0.29

SECONDARY outcome

Timeframe: 28 days

The measurement of the ECMAP(Evoked Compound Muscle Action Potentials) used surface electrodes on the forehead and electrical stimulation of the facial nerve, according to standard neurophysiological procedures. The amplitude of the ECMAP in the m. frontalis on stimulation of the facial nerve was performed by an experienced neurologist. ECMAP was assessed by an electromyography (EMG) device (TECA Sapphire - TECA Corp., Pleasantville, NY).

Outcome measures

Outcome measures
Measure	Dysport® 5U n=28 Participants Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region.	Botox® 2U n=28 Participants Two units of Botox® was administered to the other side of the frontal region.
ECMAP in m. Frontialis	492.53 microvolts Standard Deviation 290.70	468.27 microvolts Standard Deviation 263.31

SECONDARY outcome

Timeframe: 112 days

The measurement of the ECMAP(Evoked Compound Muscle Action Potentials) used surface electrodes on the forehead and electrical stimulation of the facial nerve, according to standard neurophysiological procedures. The amplitude of the ECMAP in the m. frontalis on stimulation of the facial nerve was performed by an experienced neurologist. ECMAP was assessed by an electromyography (EMG) device (TECA Sapphire - TECA Corp., Pleasantville, NY).

Outcome measures

Outcome measures
Measure	Dysport® 5U n=28 Participants Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region.	Botox® 2U n=28 Participants Two units of Botox® was administered to the other side of the frontal region.
ECMAP in m. Frontialis	482.63 microVolts Standard Deviation 279.58	539.16 microVolts Standard Deviation 387.72

Adverse Events

Dysport® 5U/ Botox® 2U

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Dysport® 5U/ Botox® 2U n=29 participants at risk Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region, that the other brand Botox® was administered two units to the other side of the frontal region.
Respiratory, thoracic and mediastinal disorders flu	3.4% 1/29 • Number of events 1 • 28 days and 112 days Patients were evaluated for adverse events regarding the use of botulinum toxin, photograph and adverse event questionaire were performed.

Additional Information

Juliana de Souza

Brazilian Center for Studies in Dermatology

Phone: +55 51 3026 2633

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place