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

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Armando Iniguez MD, Ivo Pitanguy Institute
ClinicalTrials.gov Identifier:
NCT01297634
First received: February 16, 2011
Last updated: November 22, 2011
Last verified: November 2011

February 16, 2011
November 22, 2011
May 2011
November 2011   (final data collection date for primary outcome measure)
Treatment Area [ Time Frame: Change from baseline at day 30 ] [ Designated as safety issue: Yes ]

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.

Same as current
Complete list of historical versions of study NCT01297634 on ClinicalTrials.gov Archive Site
Complete Treatment Phase [ Time Frame: Day 30 ] [ Designated as safety issue: Yes ]
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.
Same as current
Not Provided
Not Provided
 
Radial Diffusion of the Botulinum Toxin Type A (Botox®): Electromyographic Evaluation of the Frontal Muscle
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Wrinkles
  • Drug: 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 (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 (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.
  • Botulinum Toxin Type-A 1U
    Intervention: Drug: Botulinum Toxin Type-A (day 0)
  • Botulinum Toxin Type-A 2U
    Intervention: Drug: Botulinum Toxin Type-A (day 0)
  • Botulinum Toxin Type-A 3U
    Intervention: Drug: Botulinum Toxin Type-A (day 0)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
November 2011
November 2011   (final data collection date for primary outcome measure)

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.
Female
30 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01297634
191622, 396936, CEP001/11
Yes
Armando Iniguez MD, Ivo Pitanguy Institute
Ivo Pitanguy Institute
Allergan
Not Provided
Ivo Pitanguy Institute
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP