Clinical Trial to Assess Efficacy, Safety and Tolerability of Botulinum Toxin A (Xeomin®) in Trea… (NCT00986570) | Clinical Trial Compass
CompletedPhase 3
Clinical Trial to Assess Efficacy, Safety and Tolerability of Botulinum Toxin A (Xeomin®) in Treatment of Expression Wrinkles in the Upper Third of the Face
Brazil121 participantsStarted 2009-09
Plain-language summary
The purpose of this study is to determinate whether Xeomin® (Botulinum toxin Type A) is safe, effective and tolerable in woman aged 30 to 50 years old for treatment of mild, moderate or severe expression lines (wrinkles) in the upper third of the face. The main outcome was the change in appearance of the wrinkles two weeks (visit 3) after product application as compared with baseline assessment.
Who can participate
Age range30 Years – 50 Years
SexFEMALE
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Inclusion Criteria:
* Women aged 30 to 50 years old, inclusive.
* Mild, moderate or severe expression wrinkles.
* Patients who had understood and signed the Informed Consent Form.
Exclusion Criteria:
* Subjects treated with botulinum toxin on the upper third of the face within the previous 6-month period;
* Former implantation of permanent material and surgery (scars).
* Use of any anticoagulant agent up to 7 days prior to the investigational product application;
* Concomitant use of aminoglycosides or of any other drug that may impair in the neuromuscular transmission;
* Coagulopathies and local inflammation/ infection at the application site.
* Diseases which do impact on the neuromuscular function, such as: myasthenia gravis, Eaton Lambert Syndrome;
* Pregnancy or breast feeding, women with potential to become pregnant or who do not agree to use an effective contraception method (Pearl Index \< 1%);
* Allergy or known sensitivity to any of the components of the investigational drug;
* Subjects who were enrolled in other clinical trial for the last 12-month period prior to the present study, as per Resolution 251/97;
* Subjects who disagree with the study procedures, who do not sign the Informed Consent Form or who are not committed to participate in the trial.
What they're measuring
1
Treatment Success
Timeframe: Baseline (pre-treatment) and Visit 3 (Day 15)