- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00986570
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 (XEO-001/07)
Phase III Open Label 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
Study Overview
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 flaccidity being the most common and visible ones.
In both developed and emerging countries, the interest in skin ageing is, to a greater extent, the result of the progressive increase in the absolute number and the proportion of people experiencing the ageing process in the last century. The psychosocial, as well as the physiological effects of the skin ageing raised a huge demand for a better understanding of this process and, in particular, of the effective interventions.
The use of the botulinum toxin type-A (BTX/A) for aesthetic indication emerged as a result of the clinical observation of those patients treated for facial different dystonia and who presented additional improvement of their expression lines.
The expression lines are most easily noted on the upper third of the face, where surgical treatments are fully invasive and show lesser noticeable results. The upper third of the face was targeted for BTX/A treatment and reported in several scientific literature articles as well succeeded.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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São Paulo, Brazil, 04022-000
- Universidade Federal de São Paulo/Hospital São Paulo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Xeomin®
Botulinum Toxin A
|
100 U DL50 lyophilized powder for reconstitution in 1 ml Saline Solution 0.9%.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment Success
Time Frame: Baseline (pre-treatment) and Visit 3 (Day 15)
|
Success has been defined as the reduction of any grade to a lower grade of expression wrinkles in the visit 3 (day 15) compared to the baseline assessment.
The wrinkles will be classified according to the following: absence, mild, moderate, severe.
|
Baseline (pre-treatment) and Visit 3 (Day 15)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sergio Talarico, MD, Federal University of São Paulo
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- XEO-001/07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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