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

Ivo Pitanguy Institute

Status and phase: Completed; Phase 4

Conditions: Wrinkles

Treatments: Drug: Botulinum Toxin Type-A (day 0)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01297634

191622

396936 (Other Identifier)

CEP001/11 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: Female

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

64 participants in 3 patient groups

Botulinum Toxin Type-A 1U

Other group

Treatment:

Drug: Botulinum Toxin Type-A (day 0)

Drug: Botulinum Toxin Type-A (day 0)

Drug: Botulinum Toxin Type-A (day 0)

Botulinum Toxin Type-A 2U

Other group

Treatment:

Drug: Botulinum Toxin Type-A (day 0)

Drug: Botulinum Toxin Type-A (day 0)

Drug: Botulinum Toxin Type-A (day 0)

Botulinum Toxin Type-A 3U

Other group

Treatment:

Drug: Botulinum Toxin Type-A (day 0)

Drug: Botulinum Toxin Type-A (day 0)

Drug: Botulinum Toxin Type-A (day 0)