Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment

Completed · Phase 4

Conditions studied: Forehead Rhytides, Forehead Wrinkles

In brief

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.

Key facts

Study ID

NCT03799484

Run by

The University of Texas Health Science Center, Houston

People needed

14

Starts

2019-01-04

Expected to finish

2019-06-14

Last updated by the study team

2020-06-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

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

Full record on ClinicalTrials.gov

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