Radial Diffusion of the Botulinum Toxin Type A (Botox®): Electromyographic Evaluation of the Frontal Muscle
November 22, 2011 updated by: Armando Iniguez MD, Ivo Pitanguy Institute
Phase IV Study of Radial Diffusion of the Botulinum Toxin Type A: Electromyographic Evaluation of the Frontal Muscle.
This study evaluates the diffusion area (cephalic, lateral, medial and caudal points) of the botulinum toxin type A in the frontal muscle for usual concentrations and dilutions of the drug. A basal line control and After the application control will be made, and the investigators will evaluate the drug effects, based on clinical aspects, photographic registers and through electromyography exam (EMG).
Considering the results of our investigation, the investigators may propose a pattern of application of BOTULINUM TOXIN TYPE-A Botox® in the frontal area.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
RJ
-
Rio de Janeiro, RJ, Brazil, 22280-020
- Ivo Pitanguy Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Subjects who have indication for aesthetic treatment of the frontal dynamic wrinkles, in maximal contraction of the frontal muscle.
- Availability and understanding of the patient, for complete all the steps throughout the duration of the study.
- Medical history and physical examination compatible with the study.
- Informed consent signed.
Exclusion Criteria:
- Subjects with previous forehead face lifting or blepharoplasty surgery.
- Previous use of Botulinum toxin in the last 6 months.
- Forehead or eyelid asymmetry.
- Subjects with infections on site of injection or inflammatory skin diseases.
- Subjects with hypersensitivity to any component of the formulation, including albumin.
- Subjects with neuropathic or neuromuscular diseases.
- Subjects using aminoglycosides, penicillamine antibiotics, quinine and Ca2+ channel blockers.
- Subjects with pregnancy and lactation, or that planning become pregnant during the time of the study.
- Subjects with dimorphism or others psychological disorders.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Botulinum Toxin Type-A 1U
|
Botulinum Toxin Type-A 3 units. Dilution:1U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.
|
|
Other: Botulinum Toxin Type-A 2U
|
Botulinum Toxin Type-A 3 units. Dilution:1U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.
|
|
Other: Botulinum Toxin Type-A 3U
|
Botulinum Toxin Type-A 3 units. Dilution:1U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment Area
Time Frame: Change from baseline at day 30
|
Radial area (cephalic, lateral, medial and caudal points) of physioelectric activity of the frontal muscle, measured with electromyography (EMG). Clinical and Photographical register evaluation of the dynamical wrinkles in the treatment area. |
Change from baseline at day 30
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Complete Treatment Phase
Time Frame: Day 30
|
Quantity of Botulinum Toxin used in every subject to aim to complete the treatment to the rest of the frontal area, based on the results of the primary outcomes.
|
Day 30
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
November 1, 2011
Study Registration Dates
First Submitted
February 16, 2011
First Submitted That Met QC Criteria
February 16, 2011
First Posted (Estimate)
February 17, 2011
Study Record Updates
Last Update Posted (Estimate)
November 23, 2011
Last Update Submitted That Met QC Criteria
November 22, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 191622
- 396936 (Other Identifier: CEP00/11)
- CEP001/11 (Other Identifier: Research Ethics Committee, Brazil)
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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