The objective of this study is to compare the field of effects of the botulinum toxins (Dysport® and Botox®) using two equivalence-ratios and to gather supportive information, such as more detailed data on the effectiveness in reduction of wrinkles and duration of action on the upper part of the face of both products, trough scales and photographs evaluations.
This was a monocentric, prospective, randomized and double-blind study. Twenty nine female patients, presenting with moderate to severe forehead wrinkles, with sweating ability who had never undergone previous BoNT-A injections were enrolled. Subjects have received botulinum toxin type-A injections in two forehead sites, Botox 2U and Dysport 5U, both reconstituted in the same volume of 0.02 mL per point. Baseline, twenty-eight and 112 days later, clinical and photographic assessments, Minor´s test, and electromyographic (EMG) evaluations were performed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
29
Botulinum toxin A (Dysport®)will be administered according to an equivalence ratio of 2,5:1. Both reconstituted in the same volume per point, injected in the forehead determined site. -Dysport®: 5 units will be injected in the left or right forehead side.
2 units will be injected in the left or right forehead side.(opposite side of dysport injection)
Botulinum toxin A (Dysport®)will be administered according to an equivalence ratio of 2:1. Both reconstituted in the same volume per point, injected in the forehead determined site. -Dysport®: 4 units will be injected in the left or right forehead side, 2:1 ratio Dysport/Botox.
Brazilian Center for Studies in Dermatology
Porto Alegre, Rio Grande do Sul, Brazil
Horizontal Action Halo Diameter at 28 Days
The colorful complex formed by Minor's test allows the visualization of the area covered by the effects of botulinum toxin on sweat glands, also known as action halos. The horizontal diameter at day 28 were expressed in centimeters and quantified by the software Mirror® (Canfield Scientific Inc., USA).
Time frame: 28 Days
Horizontal Action Halo Diameter at 112 Days
The colorful complex formed by Minor's test allows the visualization of the area covered by the effects of botulinum toxin on sweat glands, also known as action halos. The horizontal diameter at day 112 were expressed in centimeters and quantified by the software Mirror® (Canfield Scientific Inc., USA).
Time frame: 112 days
ECMAP in m. Frontialis
The measurement of the ECMAP(Evoked Compound Muscle Action Potentials) used surface electrodes on the forehead and electrical stimulation of the facial nerve, according to standard neurophysiological procedures. The amplitude of the ECMAP in the m. frontalis on stimulation of the facial nerve was performed by an experienced neurologist. ECMAP was assessed by an electromyography (EMG) device (TECA Sapphire - TECA Corp., Pleasantville, NY).
Time frame: 28 days
ECMAP in m. Frontialis
The measurement of the ECMAP(Evoked Compound Muscle Action Potentials) used surface electrodes on the forehead and electrical stimulation of the facial nerve, according to standard neurophysiological procedures. The amplitude of the ECMAP in the m. frontalis on stimulation of the facial nerve was performed by an experienced neurologist. ECMAP was assessed by an electromyography (EMG) device (TECA Sapphire - TECA Corp., Pleasantville, NY).
Time frame: 112 days
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