Trial Outcomes & Findings for Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment (NCT NCT03799484)

Results Overview

Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

14 participants

Primary outcome timeframe

Baseline

Results posted on

2020-06-18

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants 2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other side of the forehead prior to administration of Botulinum Toxin Type A Injection.
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=14 Participants 2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other side of the forehead prior to administration of Botulinum Toxin Type A Injection.
Age, Continuous	35.5 years STANDARD_DEVIATION 6.7 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	6 Participants n=5 Participants
Race/Ethnicity, Customized White	7 Participants n=5 Participants
Region of Enrollment United States	14 Participants n=5 Participants
Distance between both lateral canthi	98.29 millimeters STANDARD_DEVIATION 3.43 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters.

Outcome measures

Outcome measures
Measure	Topical Anesthesia n=14 side of forehead (either left or right) 2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other prior to administration of Botulinum Toxin Type A Injection Botulinum toxin type A: Botulinum toxin type A will be administered to both sides 2.5% lidocaine/2.5% prilocaine: 2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead	Petrolatum n=14 side of forehead (either left or right) Petrolatum Ointment will be applied to one side of the forehead and 2.5% Lidocaine/2.5% Prilocaine Cream to the other side prior to administration of Botulinum Toxin Type A Injection Botulinum toxin type A: Botulinum toxin type A will be administered to both sides petrolatum ointment: petrolatum ointment will be applied to one side of the forehead
Eyebrow Excursion	10.57 millimeters Standard Deviation 3.3	10.57 millimeters Standard Deviation 3.16

PRIMARY outcome

Timeframe: Week 2

Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters.

Outcome measures

Outcome measures
Measure	Topical Anesthesia n=14 side of forehead (either left or right) 2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other prior to administration of Botulinum Toxin Type A Injection Botulinum toxin type A: Botulinum toxin type A will be administered to both sides 2.5% lidocaine/2.5% prilocaine: 2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead	Petrolatum n=14 side of forehead (either left or right) Petrolatum Ointment will be applied to one side of the forehead and 2.5% Lidocaine/2.5% Prilocaine Cream to the other side prior to administration of Botulinum Toxin Type A Injection Botulinum toxin type A: Botulinum toxin type A will be administered to both sides petrolatum ointment: petrolatum ointment will be applied to one side of the forehead
Eyebrow Excursion	3.46 millimeters Standard Deviation 2.76	3.43 millimeters Standard Deviation 2.93

PRIMARY outcome

Timeframe: Week 6

Participants will be asked to raise the brows, and the excursion of the brow from resting position to maximum elevation will be measured in millimeters.

Outcome measures

Outcome measures
Measure	Topical Anesthesia n=14 side of forehead (either left or right) 2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other prior to administration of Botulinum Toxin Type A Injection Botulinum toxin type A: Botulinum toxin type A will be administered to both sides 2.5% lidocaine/2.5% prilocaine: 2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead	Petrolatum n=14 side of forehead (either left or right) Petrolatum Ointment will be applied to one side of the forehead and 2.5% Lidocaine/2.5% Prilocaine Cream to the other side prior to administration of Botulinum Toxin Type A Injection Botulinum toxin type A: Botulinum toxin type A will be administered to both sides petrolatum ointment: petrolatum ointment will be applied to one side of the forehead
Eyebrow Excursion	5.96 millimeters Standard Deviation 2.62	5.68 millimeters Standard Deviation 2.55

PRIMARY outcome

Timeframe: week 16

Outcome measures

Outcome measures
Measure	Topical Anesthesia n=14 side of forehead (either left or right) 2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other prior to administration of Botulinum Toxin Type A Injection Botulinum toxin type A: Botulinum toxin type A will be administered to both sides 2.5% lidocaine/2.5% prilocaine: 2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead	Petrolatum n=14 side of forehead (either left or right) Petrolatum Ointment will be applied to one side of the forehead and 2.5% Lidocaine/2.5% Prilocaine Cream to the other side prior to administration of Botulinum Toxin Type A Injection Botulinum toxin type A: Botulinum toxin type A will be administered to both sides petrolatum ointment: petrolatum ointment will be applied to one side of the forehead
Eyebrow Excursion	8.21 millimeters Standard Deviation 2.89	8.07 millimeters Standard Deviation 2.97

SECONDARY outcome

Timeframe: week 16

Loss of Botulinum Toxin Type A effect is defined as return of baseline frontalis muscle function (function prior to injection) as indicated by eyebrow excursion measurement within 2 millimeters of baseline value.

Outcome measures

Outcome measures
Measure	Topical Anesthesia n=14 side of forehead (either left or right) 2.5% Lidocaine/2.5% Prilocaine Cream will be applied to one side of the forehead and Petrolatum Ointment to the other prior to administration of Botulinum Toxin Type A Injection Botulinum toxin type A: Botulinum toxin type A will be administered to both sides 2.5% lidocaine/2.5% prilocaine: 2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead	Petrolatum n=14 side of forehead (either left or right) Petrolatum Ointment will be applied to one side of the forehead and 2.5% Lidocaine/2.5% Prilocaine Cream to the other side prior to administration of Botulinum Toxin Type A Injection Botulinum toxin type A: Botulinum toxin type A will be administered to both sides petrolatum ointment: petrolatum ointment will be applied to one side of the forehead
Duration of Botulinum Toxin Type A Effect	14.2857 weeks Standard Error 1.2317	15.2857 weeks Standard Error 0.7301

SECONDARY outcome

Timeframe: Immediately after botox injection

A visual analogue scale will be used to assess pain. The scale ranges from 0 (no pain) to 10 (the worse pain possible), with lower scores indicating a better outcome.