MedDataX Logo

Radial Diffusion of the Botulinum Toxin Type A (Botox®): Electromyographic Evaluation of the Frontal Muscle

NCT ID: NCT01297634

Last Updated: 2011-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Wrinkles

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Botulinum toxin type A Hyperfunctional forehead lines Randomized controlled trial Double-blinded trial Electromyogram (EMG) Electromyographic activity Frontal Area

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Botulinum Toxin Type-A 1U

Group Type OTHER

Botulinum Toxin Type-A (day 0)

Intervention Type 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 2U

Group Type OTHER

Botulinum Toxin Type-A (day 0)

Intervention Type 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 3U

Group Type OTHER

Botulinum Toxin Type-A (day 0)

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Allergan

INDUSTRY

Sponsor Role collaborator

Ivo Pitanguy Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Armando Iniguez MD

Plastic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ivo Pitanguy Institute

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

396936

Identifier Type: OTHER

Identifier Source: secondary_id

CEP001/11

Identifier Type: OTHER

Identifier Source: secondary_id

191622

Identifier Type: -

Identifier Source: org_study_id