Skin Aging Clinical Trial
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
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.
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.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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