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
  Purpose

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.


Condition Intervention Phase
Wrinkles
Drug: Botulinum Toxin Type-A (day 0)
Drug: Botulinum Toxin Type-A (day 0)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase IV Study of Radial Diffusion of the Botulinum Toxin Type A: Electromyographic Evaluation of the Frontal Muscle.

Resource links provided by NLM:


Further study details as provided by Ivo Pitanguy Institute:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Enrollment: 64
Study Start Date: May 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Botulinum Toxin Type-A 1U 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.
Botulinum Toxin Type-A 2U 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.
Botulinum Toxin Type-A 3U 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.

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01297634

Locations
Brazil
Ivo Pitanguy Institute
Rio de Janeiro, RJ, Brazil, 22280-020
Sponsors and Collaborators
Ivo Pitanguy Institute
Allergan
  More Information

No publications provided

Responsible Party: Armando Iniguez MD, Plastic Surgeon, Ivo Pitanguy Institute
ClinicalTrials.gov Identifier: NCT01297634     History of Changes
Other Study ID Numbers: 191622, 396936, CEP001/11
Study First Received: February 16, 2011
Last Updated: November 22, 2011
Health Authority: Brazil: Ministry of Health
Brazil: Ethics Committee

Keywords provided by Ivo Pitanguy Institute:
Botulinum toxin type A
Hyperfunctional forehead lines
Randomized controlled trial
Double-blinded trial
Electromyogram (EMG)
Electromyographic activity
Frontal Area

Additional relevant MeSH terms:
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014