Phase 4 N=14 Randomized Double-blind Other

Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment

Forehead Rhytides · Forehead Wrinkles

Bottom Line

View on ClinicalTrials.gov: NCT03799484 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2020

Primary outcome: Primary: Eyebrow Excursion — 10.57; 10.57 millimeters

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Botulinum toxin type A (Drug); 2.5% lidocaine/2.5% prilocaine (Drug); petrolatum ointment (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The University of Texas Health Science Center, Houston
Primary completion: Jun 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Eyebrow Excursion	8.21; 8.07	—
PRIMARY Eyebrow Excursion	8.21; 8.07	—
PRIMARY Eyebrow Excursion	8.21; 8.07	—
PRIMARY Eyebrow Excursion	8.21; 8.07	—
SECONDARY Duration of Botulinum Toxin Type A Effect	14.2857; 15.2857	—
SECONDARY Perception of Pain Immediately After Injection as Assessed by a Visual Analogue Scale	2.43; 3.96	—
SECONDARY Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey	8; 2; 1; 3; 0	—
SECONDARY Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey	8; 2; 1; 3; 0	—
SECONDARY Participant Satisfaction With Overall Appearance of Forehead as Assessed by a Patient Satisfaction Survey	8; 2; 1; 3; 0	—
SECONDARY Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey	8; 2; 1; 3; 0	—
SECONDARY Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey	8; 2; 1; 3; 0	—
SECONDARY Participant Satisfaction With Appearance of Right Side of Forehead as Assessed by a Patient Satisfaction Survey	8; 2; 1; 3; 0	—
SECONDARY Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey	8; 2; 1; 3; 0	—
SECONDARY Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey	8; 2; 1; 3; 0	—
SECONDARY Participant Satisfaction With Appearance of Left Side of Forehead as Assessed by a Patient Satisfaction Survey	8; 2; 1; 3; 0	—
SECONDARY Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face	—	—
SECONDARY Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face	—	—
SECONDARY Number of Participants Who Perceive a Difference in Efficacy Between the 2 Sides of Their Face	—	—

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.

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03799484). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.