Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 1/12/2019 |
| Start Date: | January 2, 2019 |
| End Date: | September 30, 2019 |
Randomized, Single Center, Masked Study Comparing the Efficacy of Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment
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.
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.
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
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
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)
We found this trial at
1
site
Click here to add this to my saved trials
