Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Forehead Rhytides, Forehead Wrinkles

Intervention / Treatment
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* Drug: Botulinum toxin type A
* Drug: 2.5% lidocaine/2.5% prilocaine
* Device: petrolatum ointment


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Topical Anesthesia<br>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 | Drug: Botulinum toxin type A<br>* Botulinum toxin type A will be administered to both sides<br>* Other names: BTX-A;Drug: 2.5% lidocaine/2.5% prilocaine<br>* 2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead<br>* Other names: EMLA;|
| Other: Petrolatum<br>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 | Drug: Botulinum toxin type A<br>* Botulinum toxin type A will be administered to both sides<br>* Other names: BTX-A;Device: petrolatum ointment<br>* petrolatum ointment will be applied to one side of the forehead<br>* Other names: Aquaphor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Week 6 | 
| Eyebrow Excursion |  | week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Week 2 | 
| 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. | Week 6 | 
| 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. | Week 16 | 
| Participant Satisfaction With Appearance of Right Side 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. | Week 2 | 
| Participant Satisfaction With Appearance of Right Side 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. | Week 6 | 
| Participant Satisfaction With Appearance of Right Side 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. | Week 16 | 
| Participant Satisfaction With Appearance of Left Side 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. | Week 2 | 
| Participant Satisfaction With Appearance of Left Side 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. | Week 6 | 
| Participant Satisfaction With Appearance of Left Side 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. | Week 16 | 
| 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. | Week 2 | 
| 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. | Week 6 | 
| 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. | Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rhytides, Forehead Wrinkles