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Completed

NCT Number: NCT03799484

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.

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Key information

Conditions

Forehead Rhytides Forehead Wrinkles

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Robert Cizik Eye Clinic

Houston, Texas, 77030, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Botulinum Toxin Type A

Drug

Botulinum toxin type A will be administered to both sides

Other names: BTX-A

2.5% lidocaine/2.5% prilocaine

Drug

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

Other names: EMLA

petrolatum ointment

Device

petrolatum ointment will be applied to one side of the forehead

Other names: Aquaphor

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Eyebrow Excursion

    Time frame: week 16

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Robert Cizik Eye Clinic

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 10, 2019
Registry last updated
Jun 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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