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Completed

NCT Number: NCT01297634

Radial Diffusion of the Botulinum Toxin Type A (Botox®): 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.

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Key information

Conditions

Wrinkles

Age range

30 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Ivo Pitanguy Institute

Rio de Janeiro, 22280-020, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ivo Pitanguy Institute

Other

Collaborators

  • Allergan

Registry information

Official study title

Phase IV Study of Radial Diffusion of the Botulinum Toxin Type A: Electromyographic Evaluation of the Frontal Muscle.

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 17, 2011
Registry last updated
Nov 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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