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

Wrinkles Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01297634
• Other study ID #: 191622
• Secondary ID: 396936CEP001/11
• Status: Completed
• Phase: Phase 4
• First received: February 16, 2011
• Last updated: November 22, 2011
• Start date: May 2011
• Est. completion date: November 2011

Study information

• Verified date: November 2011
• Source: Ivo Pitanguy Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of HealthBrazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wrinkles

Intervention

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 (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 (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.

Locations

Country	Name	City	State
Brazil	Ivo Pitanguy Institute	Rio de Janeiro	RJ

Sponsors (2)

Lead Sponsor	Collaborator
Ivo Pitanguy Institute	Allergan

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline at day 30	Yes
Secondary	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.	Day 30	Yes