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KLOX Technologies annonce qu'elle a obtenu l'approbation européenne du marquage CE sur son produit novateur et non invasif pour l'acné simple
Date:11/19/2013

soutien de la demande sur cet appareil médical était fondée sur un essai pour homologation européenne réalisé en Europe. Dans cette étude, l'efficacité du système a été démontrée chez les patients atteints d'acné simple modérée à sévère. Les résultats se sont avérés cliniquement et statistiquement significatifs selon le paramètre principal d'évaluation (p < 0,0001) et tous les autres paramètres secondaires d'évaluation, affichant un profil d'innocuité extrêmement avantageux. L'étude de prolongation de trois mois a démontré un profil d'efficacité et d'innocuité similaire. La persistance des effets s'est maintenue chez 92 % des membres de la cohorte qui avait satisfait le paramètre principal d'évaluation de l'essai pour homologation, établissant de ce fait une persistance des effets sur au moins six mois.

À propos de l'acné simple
L'acné simple est une maladie chronique qui peut avoir des effets physiques, sociaux et psychologiques dévastateurs pour les gens qui en souffrent, tout particulièrement dans les cas d'acné modérée à sévère. L'acné simple touche plus de 150 millions de personnes à l'échelle mondiale. Cette maladie compte pour 30 % des visites en dermatologie et plus de 40 % des gens qui en souffrent sont à la recherche d'un traitement plus efficace et sécuritaire comparativement aux traitements actuels offerts sur le marché. Bon nombre de traitements de l'acné topiques, oraux ou photodynamiques sont caractérisés par une efficacité et une persistance variables, des programmes de traitement systémiques, une faible tolérabilité chez les patients et, dans la majorité des cas, des effets secondaires.

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