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

Ivo Pitanguy Institute64 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Wrinkles

Interventions

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.

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.

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Change from baseline at day 30

Secondary Outcomes

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.

Time frame: Day 30