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Field of Effects of Two Commercial Preparations of Botulinum Toxin Type A

NCT00989768 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2010-06-02

Study results available
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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.

Conditions

  • Wrinkles in Frontal Area

Interventions

DRUG

Botulinum Toxin Type A (Dysport®)

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.

DRUG

Botulinum Toxin Type A/Botox®

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

DRUG

Botulinum Toxin Type A/Dysport®

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.

Sponsors & Collaborators

  • Brazilan Center for Studies in Dermatology

    lead OTHER

Principal Investigators

  • Doris M Hexsel, MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2007-11-30
Completion
2007-12-31

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 NCT00989768 on ClinicalTrials.gov