NCT01297634

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 17, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

November 23, 2011

Status Verified

November 1, 2011

Enrollment Period

6 months

First QC Date

February 16, 2011

Last Update Submit

November 22, 2011

Conditions

Wrinkles

Keywords

Botulinum toxin type AHyperfunctional forehead linesRandomized controlled trialDouble-blinded trialElectromyogram (EMG)Electromyographic activityFrontal Area

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Complete Treatment Phase

    Day 30

Study Arms (3)

Botulinum Toxin Type-A 1U

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

Botulinum Toxin Type-A 2U

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

Botulinum Toxin Type-A 3U

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

Interventions

Botulinum Toxin Type-A (day 0)DRUG

* 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 1U

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ivo Pitanguy Institute

Rio de Janeiro, Rio de Janeiro, 22280-020, Brazil

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Plastic Surgeon

Study Record Dates

First Submitted

February 16, 2011

First Posted

February 17, 2011

Study Start

May 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

November 23, 2011

Record last verified: 2011-11

Locations

BR(1)