CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 29 enrolled
Drug / intervention
Botulinum Toxin Type A (Dysport®) +2 moredrug
Likely dose
Botulinum Toxin Type A (Dysport®) 5 unitsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00989768
NCT00989768Phase 4Completed
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Field Effects of Two Commercial Preparations of Botulinum Toxin Type a Administered to the Frontalis Muscles

Hexsel Dermatology Clinic·interventional·Posted Oct 6, 2009·Updated Jun 2, 2010

In Brief

A Phase 4 clinical trial evaluating Botulinum Toxin Type A (Dysport®), Botulinum Toxin Type A/Botox®, and 1 other intervention for Wrinkles in Frontal Area. Completed, enrolled 29 participants across 1 site.

Detailed Summary

The objective of this study is to compare the field of effects of the botulinum toxins (Dysport® and Botox®) using two equivalence-ratios and to gather supportive information, such as more detailed data on the effectiveness in reduction of wrinkles and duration of action on the upper part of the face of both products, trough scales and photographs evaluations.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWrinkles in Frontal Area
CountriesBrazil
Collaborators--

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 6, 2009
Enrollment StartMay 1, 2005
Primary CompletionNov 1, 2007
Study CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 16.7 years ago

Interventions

Botulinum Toxin Type A (Dysport®)drug

Botulinum toxin A (Dysport®)will be administered according to an equivalence ratio of 2,5:1. Both reconstituted in the same volume per point, injected in the forehead determined site. -Dysport®: 5 units will be injected in the left or right forehead side.

Botulinum Toxin Type A/Botox®drug

2 units will be injected in the left or right forehead side.(opposite side of dysport injection)

Botulinum Toxin Type A/Dysport®drug

Botulinum toxin A (Dysport®)will be administered according to an equivalence ratio of 2:1. Both reconstituted in the same volume per point, injected in the forehead determined site. -Dysport®: 4 units will be injected in the left or right forehead side, 2:1 ratio Dysport/Botox.