Trial Outcomes & Findings for Phase IV Study On Muscle Activity Of Two Commercial Preparations Of Botulinum (NCT NCT01728337)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

80 participants

Primary outcome timeframe

5 months after intervention

Results posted on

2019-07-26

Participant Flow

All patients included in this study were recruted from two research centers.

We did not have any drop-out in this study.

Participant milestones

Participant milestones
Measure	Dysport and Xeomin Dysport® was injected on the one side of the forehead and Xeomin® was injected on the other side of the forehead.
Overall Study STARTED	80
Overall Study COMPLETED	80
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase IV Study On Muscle Activity Of Two Commercial Preparations Of Botulinum

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Xeomin and Dysport n=80 Participants Xeomin® was injected on the one side of the forehead and Dysport® was injected on the other side of the forehead.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	80 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	47 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	80 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Brazil	80 participants n=5 Participants
Evoked Compound Muscle Action Potentials	1053 mV STANDARD_DEVIATION 282 • n=5 Participants

PRIMARY outcome

Timeframe: 5 months after intervention

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Dysport n=80 Participants Dysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead.	Xeomin n=80 Participants Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead.
Percentage of Responders After 5 Months After the Procedure	37 percentage of participants	34 percentage of participants

SECONDARY outcome

Timeframe: 5 months after the procedure.

Population: All subjects have received both treatments.

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.

Outcome measures

Outcome measures
Measure	Dysport n=80 Participants Dysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead.	Xeomin n=80 Participants Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead.
Maximum Evoked Compound Muscle Action Potential	694 mV Standard Deviation 391	677 mV Standard Deviation 387

Adverse Events

Dysport

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Xeomin

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Dysport n=80 participants at risk Dysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead.	Xeomin n=80 participants at risk Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead.
Skin and subcutaneous tissue disorders Worsening of Glabellar frown lines	1.2% 1/80 • Number of events 1 • 6 months	1.2% 1/80 • Number of events 1 • 6 months
Skin and subcutaneous tissue disorders Injection site bleeding	1.2% 1/80 • Number of events 1 • 6 months	1.2% 1/80 • Number of events 1 • 6 months

Additional Information

Dr Doris Hexsel

CBED

Phone: 30262633

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place