NCT03799484

Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Conditions

• Forehead Rhytides
• Forehead Wrinkles

Interventions

Type	Name	Description
DRUG	Botulinum toxin type A	Botulinum toxin type A will be administered to both sides
DRUG	2.5% lidocaine/2.5% prilocaine	2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead
DEVICE	petrolatum ointment	petrolatum ointment will be applied to one side of the forehead

Timeline

• Start date: 2019-01-04
• Primary completion: 2019-06-14
• Completion: 2019-06-14
• First posted: 2019-01-10
• Last updated: 2020-06-18
• Results posted: 2020-06-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study