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Trial Outcomes & Findings for Comparison of Two Commercial Preparations of Botulinum Toxin Type A (NCT NCT00959907)

NCT ID: NCT00959907

Last Updated: 2009-12-15

Results Overview

Minor's test permits the visualization of the effect of botulinum toxin in the injected area,also called action halos. Mirror is a computer program that allows, through photogrpahs, measuring the horizontal diameter and the area of action halos.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

29 participants

Primary outcome timeframe

28 days

Results posted on

2009-12-15

Participant Flow

Recruitment process: It is planned to recruit a total of 58 subjects at one single centre, Brazilian Center For Studies in Dermatology, in Porto Alegre, Brazil. The anticipated drop out rate is 10%. Baseline evaluation: May 2005 to July 2007.

13 volunteers were excluded; (screen failure) Iodine allergy=2 Minor´s Test failure=6 Mild wrinkles=3 Inclusion criteria failure=2

Participant milestones

Participant milestones
Measure
BoNT A1(4U)
Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
BoNT-A2(2U)
Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
Overall Study
STARTED
30
29
Overall Study
COMPLETED
27
28
Overall Study
NOT COMPLETED
3
1

Reasons for withdrawal

Reasons for withdrawal
Measure
BoNT A1(4U)
Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
BoNT-A2(2U)
Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
Overall Study
Protocol Violation
0
1
Overall Study
Adverse Event
1
0
Overall Study
Withdrawal by Subject
2
0

Baseline Characteristics

Comparison of Two Commercial Preparations of Botulinum Toxin Type A

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
BoNT A1(4U)
n=30 Participants
Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
BoNT-A2(2U)
n=29 Participants
Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
Total
n=59 Participants
Total of all reporting groups
Age Continuous
44.77 years
STANDARD_DEVIATION 8.67 • n=5 Participants
41.86 years
STANDARD_DEVIATION 11.98 • n=7 Participants
42.88 years
STANDARD_DEVIATION 10.54 • n=5 Participants
Sex: Female, Male
Female
30 Participants
n=5 Participants
29 Participants
n=7 Participants
59 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Population: The analysis was intention to treat (ITT); One drop out, from baseline to visit 1(intervention) and 3 drop outs from visit 1 to visit 2 (28 days after botulinum toxin injections). Started 59 volunteers - 4 drop outs, there was 55 volunteers in the first analysis.

Minor's test permits the visualization of the effect of botulinum toxin in the injected area,also called action halos. Mirror is a computer program that allows, through photogrpahs, measuring the horizontal diameter and the area of action halos.

Outcome measures

Outcome measures
Measure
BoNT-A2(2U)
n=28 Participants
Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
BoNT A1(4U)
n=27 Participants
Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
Horizontal Action Halo Diameter at 28 Days
1.0670 centimeter
Standard Deviation 0.2239
1.0526 centimeter
Standard Deviation 0.3638

PRIMARY outcome

Timeframe: 28 days

ECMAP(Evoked Compound Muscle Action Potentials) was accessed by an electromyography (EMG) device (TECA Sapphire - TECA Corp., Pleasantville, NY).

Outcome measures

Outcome measures
Measure
BoNT-A2(2U)
n=28 Participants
Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
BoNT A1(4U)
n=28 Participants
Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
ECMAP in m. Frontialis BoNT A1(4U) X BoNT A2 (2U)
289.00 microvolts
Standard Deviation 303.86
276.18 microvolts
Standard Deviation 319.15

PRIMARY outcome

Timeframe: 112 days

Population: Intention to treat analysis. 55 volunteers - One drop out from visit 2 (28 days) to visit 3 (112 days): 54 volunteers.

Minor's test permits the visualization of the effect of botulinum toxin in the injected area,also called action halos. Mirror is a computer program that allows, through photogrpahs, measuring the horizontal diameter and the area of action halos.

Outcome measures

Outcome measures
Measure
BoNT-A2(2U)
n=28 Participants
Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
BoNT A1(4U)
n=26 Participants
Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
Horizontal Action Halo Diameter at 112 Days
1.1196 centimeter
Standard Deviation 0.2620
0.8742 centimeter
Standard Deviation 0.3333

Adverse Events

BoNT A1(4U)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

BoNT-A2(2U)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Débora Zechmeister do Prado

CBED

Phone: 55 51 30262633

Results disclosure agreements

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