Clinical trial NCT03799484: Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment
Official title: Randomized, Single Center, Masked Study Comparing the Efficacy of Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Forehead Rhytides
Forehead Wrinkles
Keywords: Rhytides
Forehead Wrinkles
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Robert Cizik Eye Clinic
First posted: 2019-01-10
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Eligibility criteria: 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)

Primary outcomes:
measure: Eyebrow Excursion
timeFrame: Baseline
measure: Eyebrow Excursion
timeFrame: Week 2
measure: Eyebrow Excursion
timeFrame: Week 6
measure: Eyebrow Excursion
timeFrame: week 16
Secondary outcomes:
measure: Duration of Botulinum Toxin Type A Effect
timeFrame: week 16
measure: Perception of Pain Immediately After Injection as Assessed by a Visual Analogue Scale
timeFrame: Immediately after botox injection
measure: Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey
timeFrame: Week 2
measure: Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey
timeFrame: Week 6
measure: Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey
timeFrame: Week 16
measure: Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey
timeFrame: Week 2
measure: Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey
timeFrame: Week 6
measure: Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey
timeFrame: Week 16
measure: Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey
timeFrame: Week 2
measure: Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey
timeFrame: Week 6
measure: Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey
timeFrame: Week 16
measure: Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face
timeFrame: Week 2
measure: Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face
timeFrame: Week 6
measure: Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face
timeFrame: Week 16
Other outcomes:
Locations:
city: Houston
country: United States
facility: Robert Cizik Eye Clinic
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Karina Richani-Reverol, MD
role: PRINCIPAL_INVESTIGATOR
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