Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment

Randomized, Single Center, Masked Study Comparing the Efficacy of Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03799484

Enrollment

Registered

2019-01-10

Start date

2019-01-04

Completion date

2019-06-14

Last updated

2020-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Forehead Rhytides, Forehead Wrinkles

Keywords

Rhytides, Forehead Wrinkles

Brief summary

The purpose of this study is to determine whether there is a difference in clinical effect, duration of effect, level of discomfort and patient satisfaction in patients receiving topical anesthesia on one side of the forehead and petrolatum ointment on the other prior to Botulinum Toxin Type A administration for the treatment of forehead rhytides.

Detailed description

This is a prospective, randomized, double-masked, comparative study in patients who present at the Robert Cizik Eye Clinic with horizontal forehead rhytides requiring treatment with botulinum toxin Type A (Botox ®; Allergan, Irvine, CA, USA). The objective of this study is to determine whether there is a difference in clinical effect (weakness/paralysis of the frontalis muscle), duration of effect, level of discomfort and patient satisfaction in patients receiving topical anesthesia (2.5% lidocaine/2.5 % prilocaine cream, Impax Laboratories, LLC) on one side of the forehead and petrolatum ointment on the other prior to BTX-A administration for the treatment of forehead rhytides. * Primary outcome variable is change of eyebrow excursion on each side of the forehead from baseline to each follow-up visit. * Secondary outcome variables * Duration of effect, defined as the elapsed time from injection to the end of botulinum, such that return of baseline frontalis function, i.e. within 2 mm of baseline value * Perception of pain immediately after injection at each side * Patient satisfaction for each side * Patient's perception of difference in efficacy

Interventions

DRUGBotulinum toxin type A

Botulinum toxin type A will be administered to both sides

DRUG2.5% lidocaine/2.5% prilocaine

2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead

DEVICEpetrolatum ointment

petrolatum ointment will be applied to one side of the forehead

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Outcomes Assessor)

Masking description

Randomization will only be known by the principal investigator performing the injections and will not be disclosed to the participants or the brow excursion examiner.

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* 18 to 65 years of age * Presence of horizontal forehead rhytides * Good eyebrow excursion (greater than or equal to 5 mm) * Able to understand and sign an informed consent form that has been approved by the Committee for the Protection of Human Subjects

Exclusion criteria

* Previous injection of botulinum toxin in the intended treatment area for the study within the last 4 months * Known allergy to botulinum toxin * Known history of sensitivity to local anesthetics of the amide type * Existing disorder of neuromuscular transmission * Usage of medication with effect on neuromuscular function * Women of childbearing potential (who are not postmenopausal for at least 1 year or surgically sterile), who are pregnant or nursing or intend to become pregnant during the time of the study * Significant brow asymmetry (\> 5mm) * Unable to follow-up for the duration of the study (16 weeks)

Design outcomes

Primary

Measure	Time frame	Description
Eyebrow Excursion	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.

Secondary

Measure	Time frame	Description
Perception of Pain Immediately After Injection as Assessed by a Visual Analogue Scale	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.
Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey	Week 2	The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.
Duration of Botulinum Toxin Type A Effect	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.
Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey	Week 2	The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.
Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face	Week 2	Participants will be asked if there is a noticeable difference between the 2 sides of their face.
Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey	Week 2	The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	14
Total	14

Baseline characteristics

Characteristic	All Participants
Age, Continuous	35.5 years STANDARD_DEVIATION 6.7
Distance between both lateral canthi	98.29 millimeters STANDARD_DEVIATION 3.43
Race/Ethnicity, Customized Asian	1 Participants
Race/Ethnicity, Customized Hispanic	6 Participants
Race/Ethnicity, Customized White	7 Participants
Region of Enrollment United States	14 Participants
Sex: Female, Male Female	9 Participants
Sex: Female, Male Male	5 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 14	0 / 14
other Total, other adverse events	0 / 14	0 / 14
serious Total, serious adverse events	0 / 14	0 / 14

Outcome results

Primary

Eyebrow Excursion

Time frame: week 16

Arm	Measure	Value (MEAN)	Dispersion
Topical Anesthesia	Eyebrow Excursion	8.21 millimeters	Standard Deviation 2.89
Petrolatum	Eyebrow Excursion	8.07 millimeters	Standard Deviation 2.97

Primary

Eyebrow Excursion

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.

Time frame: Baseline

Arm	Measure	Value (MEAN)	Dispersion
Topical Anesthesia	Eyebrow Excursion	10.57 millimeters	Standard Deviation 3.3
Petrolatum	Eyebrow Excursion	10.57 millimeters	Standard Deviation 3.16

Primary

Eyebrow Excursion

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.

Time frame: Week 2

Arm	Measure	Value (MEAN)	Dispersion
Topical Anesthesia	Eyebrow Excursion	3.46 millimeters	Standard Deviation 2.76
Petrolatum	Eyebrow Excursion	3.43 millimeters	Standard Deviation 2.93

Primary

Eyebrow Excursion

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.

Time frame: Week 6

Arm	Measure	Value (MEAN)	Dispersion
Topical Anesthesia	Eyebrow Excursion	5.96 millimeters	Standard Deviation 2.62
Petrolatum	Eyebrow Excursion	5.68 millimeters	Standard Deviation 2.55

Secondary

Duration of Botulinum Toxin Type A Effect

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.

Time frame: week 16

Arm	Measure	Value (MEAN)	Dispersion
Topical Anesthesia	Duration of Botulinum Toxin Type A Effect	14.2857 weeks	Standard Error 1.2317
Petrolatum	Duration of Botulinum Toxin Type A Effect	15.2857 weeks	Standard Error 0.7301

Secondary

Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face

Participants will be asked if there is a noticeable difference between the 2 sides of their face.

Time frame: Week 2

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Topical Anesthesia	Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face	3 Participants

Secondary

Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face

Participants will be asked if there is a noticeable difference between the 2 sides of their face.

Time frame: Week 16

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Topical Anesthesia	Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face	0 Participants

Secondary

Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face

Participants will be asked if there is a noticeable difference between the 2 sides of their face.

Time frame: Week 6

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Topical Anesthesia	Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face	2 Participants

Secondary