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)
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|ClinicalTrials.gov Identifier: NCT00986570|
Recruitment Status : Completed
First Posted : September 30, 2009
Results First Posted : December 6, 2010
Last Update Posted : December 11, 2015
|Condition or disease||Intervention/treatment||Phase|
|Skin Aging||Biological: Botulinum Toxin A||Phase 3|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||121 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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 Start Date :||September 2009|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||November 2010|
Botulinum Toxin A
Biological: Botulinum Toxin A
100 U DL50 lyophilized powder for reconstitution in 1 ml Saline Solution 0.9%.
Other Name: Xeomin®
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00986570
|Universidade Federal de São Paulo/Hospital São Paulo|
|São Paulo, Brazil, 04022-000|
|Principal Investigator:||Sergio Talarico, MD||Federal University of São Paulo|