- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00989768
Field of Effects of Two Commercial Preparations of Botulinum Toxin Type A
Field Effects of Two Commercial Preparations of Botulinum Toxin Type a Administered to the Frontalis Muscles
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brazil, 90570 040
- Brazilian Center For Studies in Dermatology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Written Informed Consent (Annex 1)
- Female
- Subjects agreeing to take part in all procedures of the study, including botulinum toxin applications, Minor's test, measurement of Evoked Potentials, photographs, etc.), after being fully informed on the objectives and nature of the investigations
- Subjects aged between 18 and 60 years
- Subjects presenting with moderate to severe wrinkles on the forehead under maximum voluntary contraction of the m. frontalis
Subjects with positive Minor's test showing sweating on the forehead in standardized conditions described in Annex 2
*The Minor's Test will be the last inclusion criterion to be evaluated. Only these patients eligible according to the other inclusion criteria will undergo the Minor's Test to evaluate their sweating on the forehead. The cut off point is a positive Minor's Test (Level +1) - only subjects with Minor's Test (Level +1) will be recruited in the study (Annex 2).
- Medical history and physical examination which, based on the investigator's opinion, do not prevent the patient from taking part in the study and use the products under investigation
- Subjects of childbearing age should present a negative urine pregnancy test at baseline and should be using an effective contraceptive method;
- Availability of the patient throughout the duration of the study (112 days)
- Subject agrees not to undergo other cosmetic or dermatological procedures during the study
- Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by this protocol
Exclusion Criteria:
- Pregnant women or women intending to become pregnant in the next 4 months after screening for eligibility
- Subjects who are lactating
- Subjects having undergone botulinum toxin treatment within the last 6 months
- Subjects participating in other clinical trials
- Any prior surgery affecting the frontalis and/or orbicularis muscles, prior blepharoplasty or brow lift
- Any prior cosmetic procedures, including fillers, or scars that may interfere with the study results
- Subjects presenting fronto-parietal alopecia according to the Norwood-Hamilton classification
- Subjects with neoplastic, muscular or neurological diseases
- Subjects using aminoglycoside and penicillamine antibiotics, quinine and Ca2+ channel blockers
- Subjects with inflammation or active infection in the area to be injected
- Subjects presenting evident facial asymmetry
- Subjects with a history of adverse effects, such as sensitivity to the components of the formula, ptosis or any other adverse effect, which in the investigator's opinion should prevent the patient from participating in the study
- Subjects presenting myasthenia gravis, Eaton-Lambert Syndrome and motor neuron diseases
- Subjects with coagulation disorders or using anticoagulants
- Subjects with known systemic autoimmune diseases
- Subjects with a history of medical treatment non-adherence or showing unwillingness to adhere to the study protocol
- Any condition that, in the opinion of the investigator, can compromise the evaluation of the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Botulinum toxin type - A
Dysport® compared to Botox®
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Horizontal Action Halo Diameter at 28 Days
Time Frame: 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).
|
28 Days
|
Horizontal Action Halo Diameter at 112 Days
Time Frame: 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).
|
112 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ECMAP in m. Frontialis
Time Frame: 28 days
|
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).
|
28 days
|
ECMAP in m. Frontialis
Time Frame: 112 days
|
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).
|
112 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Doris M Hexsel, MD
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01-CBED06b
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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