Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment

Phase 4

Completed

Conditions: Forehead Rhytides
Forehead Wrinkles

Interventions: Drug: Botulinum toxin type A
Device: petrolatum ointment
Drug: 2.5% lidocaine/2.5% prilocaine

Registration Number: NCT03799484

Lead Sponsor: The University of Texas Health Science Center, Houston

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 14

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Petrolatum	Botulinum toxin type A	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
Petrolatum	petrolatum ointment	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
Topical Anesthesia	2.5% lidocaine/2.5% prilocaine	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
Topical Anesthesia	Botulinum toxin type A	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

Primary Outcome Measures

Name	Time	Method
Eyebrow Excursion	week 16

Secondary Outcome Measures

Name	Time	Method
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 Right Side of Forehead as Assessed by a Patient Satisfaction Survey	Week 16	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 16	Participants will be asked if there is a noticeable difference between the 2 sides of their face.
Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey	Week 16	The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.
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 Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey	Week 16	The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.