Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment

The University of Texas Health Science Center, Houston14 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Forehead Rhytides Forehead Wrinkles

Interventions

Botulinum toxin type ADRUG

Botulinum toxin type A will be administered to both sides

2.5% lidocaine/2.5% prilocaineDRUG

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

petrolatum ointmentDEVICE

petrolatum ointment will be applied to one side of the forehead

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Robert Cizik Eye Clinic

Houston, Texas, United States

Outcomes

Primary Outcomes

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

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

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

Eyebrow Excursion

Time frame: week 16

Secondary Outcomes

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

Perception of Pain Immediately After Injection as Assessed by a Visual Analogue Scale

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.

Time frame: Immediately after botox injection

Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey

The survey will be assessed using a rating scale with the following categories: very satisfied, satisfied, neutral, dissatisfied, and very dissatisfied.

Data from ClinicalTrials.gov

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