At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase Iv Study On The Safety And Efficacy Of The Full Face Applications Of Variable Doses Of 125 To 250 Units Of A Commercial Botulinum Toxin Type A (Dysport®)
In Brief
A Phase 4 clinical trial evaluating Botulinum toxin for Sun-induced Wrinkles. Completed, enrolled 90 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.