Status:
COMPLETED
Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
Robert Cizik Eye Clinic
Conditions:
Forehead Rhytides
Forehead Wrinkles
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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...
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 Ty...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2019
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03799484
Start Date
January 4 2019
End Date
June 14 2019
Last Update
June 18 2020
Active Locations (1)
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1
Robert Cizik Eye Clinic
Houston, Texas, United States, 77030