Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment

• Status: Completed
• Trial end date: 2019-06-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Collaborator: Robert Cizik Eye Clinic
• Treatments: abobotulinumtoxinA; Anesthetics; Botulinum Toxins; Botulinum Toxins, Type A; Lidocaine; onabotulinumtoxinA; Petrolatum; Prilocaine

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)