WrinklesPhase 4NCT01297634
Radial Diffusion of the Botulinum Toxin Type A (Botox®): Electromyographic Evaluation of the Frontal Muscle
A Phase 4 study testing Botulinum Toxin Type-A (day 0) in people with Wrinkles, run by Ivo Pitanguy Institute at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Wrinkles
- What is being tested?
- Botulinum Toxin Type-A (day 0)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteBrazil
- Study dates
- May 2011to Nov 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Wrinkles
- Being tested
- Botulinum Toxin Type-A (day 0)
- Keywords
- Botulinum toxin type A, Hyperfunctional forehead lines, Randomized controlled trial, Double-blinded trial, Electromyogram (EMG), Electromyographic activity, Frontal Area
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin Type-A (day 0)Drug
- Botulinum Toxin Type-A 1 unit. Dilution:1U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.
- Botulinum Toxin Type-A 1 unit. Dilution: 0,5U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.
- Botulinum Toxin Type-A 1 unit. Dilution: 0,25U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.
Botulinum Toxin Type-A (day 0)Drug
- Botulinum Toxin Type-A 2 Units. Dilution:1U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.
- Botulinum Toxin Type-A 2 units. Dilution: 0,5U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.
- Botulinum Toxin Type-A 2 units. Dilution: 0,25U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.
Botulinum Toxin Type-A (day 0)Drug
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.
- Botulinum Toxin Type-A 3 units. Dilution: 0,5U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.
- Botulinum Toxin Type-A 3 units. Dilution: 0,25U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin Type-A 1U | Other | Not described Receives: Drug: Botulinum Toxin Type-A (day 0) |
| Botulinum Toxin Type-A 2U | Other | Not described Receives: Drug: Botulinum Toxin Type-A (day 0) |
| Botulinum Toxin Type-A 3U | Other | Not described Receives: Drug: Botulinum Toxin Type-A (day 0) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Area
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.
Measured: Change from baseline at day 30
Secondary outcomes (1)
Complete Treatment Phase
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.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startMay 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinklesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ivo Pitanguy Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Principal investigator, Armando Iniguez MD, Ivo Pitanguy Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297634
- Sponsor's protocol ID
- 191622
- Other IDs
- 396936, CEP001/11
- Status last verified
- Nov 2011
- First submitted
- 16 Feb 2011
- Last updated
- 23 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of Radial Diffusion of the Botulinum Toxin Type A: Electromyographic Evaluation of the Frontal Muscle.
- ClinicalTrials.gov ID
- NCT01297634
- Acronym / sponsor ID
- 191622
- Conditions
- Wrinkles
- Keywords
- Botulinum toxin type A, Hyperfunctional forehead lines, Randomized controlled trial, Double-blinded trial, Electromyogram (EMG), Electromyographic activity, Frontal Area
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ivo Pitanguy InstituteUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- May 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 17 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin Type-A 1U | Other | Drug: Botulinum Toxin Type-A (day 0) |
| Botulinum Toxin Type-A 2U | Other | Drug: Botulinum Toxin Type-A (day 0) |
| Botulinum Toxin Type-A 3U | Other | Drug: Botulinum Toxin Type-A (day 0) |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin Type-A (day 0)* Botulinum Toxin Type-A 1 unit. Dilution:1U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle. * Botulinum Toxin Type-A 1 unit. Dilution: 0,5U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle. * Botulinum Toxin Type-A 1 unit. Dilution: 0,25U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle. | Drug | Botulinum Toxin Type-A 1U |
| Botulinum Toxin Type-A (day 0)* Botulinum Toxin Type-A 2 Units. Dilution:1U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle. * Botulinum Toxin Type-A 2 units. Dilution: 0,5U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle. * Botulinum Toxin Type-A 2 units. Dilution: 0,25U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle. | Drug | Botulinum Toxin Type-A 2U |
| Botulinum Toxin Type-A (day 0)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. * Botulinum Toxin Type-A 3 units. Dilution: 0,5U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle. * Botulinum Toxin Type-A 3 units. Dilution: 0,25U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle. | Drug | Botulinum Toxin Type-A 3U |
Primary outcome
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.
1 secondary outcome
Complete Treatment Phase
Time frame: Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum Toxin Type-A (day 0) in people with Wrinkles, run by Ivo Pitanguy Institute at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Area (time frame: Change from baseline at day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2011.