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

NCT01297634 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2011-11-23

No results posted yet for this study

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.

Conditions

  • Wrinkles

Interventions

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.

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • Ivo Pitanguy Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01297634 on ClinicalTrials.gov