Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment

June 1, 2020 updated by: Karina Richani-Reverol, The University of Texas Health Science Center, Houston

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Robert Cizik Eye Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eyebrow Excursion
Time Frame: 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.
Baseline
Eyebrow Excursion
Time Frame: 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.
Week 2
Eyebrow Excursion
Time Frame: 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.
Week 6
Eyebrow Excursion
Time Frame: week 16
week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Botulinum Toxin Type A Effect
Time Frame: 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.
week 16
Perception of Pain Immediately After Injection as Assessed by a Visual Analogue Scale
Time Frame: 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.
Immediately after botox injection
Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey
Time Frame: Week 2
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
Time Frame: Week 6
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
Time Frame: Week 16
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
Time Frame: Week 2
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
Time Frame: Week 6
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
Time Frame: Week 16
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
Time Frame: Week 2
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
Time Frame: Week 6
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
Time Frame: Week 16
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
Time Frame: Week 2
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
Time Frame: Week 6
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
Time Frame: Week 16
Participants will be asked if there is a noticeable difference between the 2 sides of their face.
Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

Robert Cizik Eye Clinic

Investigators

  • Principal Investigator: Karina Richani-Reverol, MD, The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2019

Primary Completion (Actual)

June 14, 2019

Study Completion (Actual)

June 14, 2019

Study Registration Dates

First Submitted

January 3, 2019

First Submitted That Met QC Criteria

January 7, 2019

First Posted (Actual)

January 10, 2019

Study Record Updates

Last Update Posted (Actual)

June 18, 2020

Last Update Submitted That Met QC Criteria

June 1, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-18-0908

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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