Status:
COMPLETED
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
Lead Sponsor:
Biolab Sanus Farmaceutica
Conditions:
Skin Aging
Eligibility:
FEMALE
30-50 years
Phase:
PHASE3
Brief 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 express...
Detailed Description
Ageing is a dynamic and unchangeable process involving all individuals and affecting the several organic systems. This process is expressed through multiple symptoms and signs, the wrinkles and flacci...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00986570
Start Date
September 1 2009
End Date
November 1 2010
Last Update
December 11 2015
Active Locations (1)
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1
Universidade Federal de São Paulo/Hospital São Paulo
São Paulo, São Paulo, Brazil, 04022-000