Forehead Wrinkles Clinical Trial
Official title:
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.
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
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01950065 -
Effectiveness and Safety Study of the Iovera Device for the Temporary Reduction in the Appearance of Forehead Wrinkles
|
N/A | |
| Completed |
NCT00612378 -
A Multi-center Acute Efficacy Trial of GFX For Reduction of Glabellar Furrowing
|
N/A |