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Safety and Efficacy of the Full Face Applications of Variable Doses of a Commercial Botulinum Toxin Type a (Dysport®)

NCT01032954 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2020-10-14

Study results available
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Summary

This is an open-label and phase IV study of full face injections of variable doses of botulinum toxin type A (BT-A). As it is an open-label and not blind study, both investigator and subjects will know the injection local and doses of the study drug. Patients will be randomized into 3 different groups. Each group will receive a specific dose according with the indication evaluated by the investigator. Six visits will be schedule in this study.

Conditions

  • Sun-induced Wrinkles

Interventions

DRUG

Botulinum toxin

Drug: Botulinum toxin Indications for eligibility and total doses that will be applied in each part of the face, at visit 1: Upper face: * Crow's feet wrinkles - 70 units * Glabella - 50 units * Forehead - 40 units Mid face: * Lower eyelid - 5 units * Nasal wrinkles - 20 units * Malar wrinkles - 10 units Lower face: * Peri-oral wrinkles - 15 units * Asymmetric smile or gummy smile - 5 units * "Cellulitic chin" - 20 units * Marionette lines - 25 U According to the patients needs, the doses can vary ±10% in terms of the amount of units that will be injected. Patients will be allocated in each group and receive the doses described above at visit 1. At visit 2, all the patients will receive a touch-up of a standard dose of 25 U, distributed on the treated areas according patient's needs.

Sponsors & Collaborators

  • Brazilan Center for Studies in Dermatology

    lead OTHER

Principal Investigators

  • Doris M Hexsel, MD · Brazilian Center for Studies in Dermatology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-12-31
Completion
2010-12-31

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 NCT01032954 on ClinicalTrials.gov