Skin Quality Clinical Trial
Official title:
Evaluation of Skin Quality Improvement When Hyper-Diluted OnabotulinumtoxinA (Botox®, Botox® Cosmetic /BTXa/) is Injected Into The Superficial Dermis of the Mid-Face
The purpose of this study is to comprehensively investigate and objectively demonstrate the effectiveness of hyperdiltue Botox® Cosmetic in improving overall skin quality, more specifically evenness of skin tone, reduction of pore size and improvement in the appearance of preexisting skin scars.
The purpose of this study is to comprehensively investigate and objectively demonstrate the
effectiveness of hyperdiltue Botox® Cosmetic in improving overall skin quality, more
specifically evenness of skin tone, reduction of pore size and improvement in the appearance
of preexisting skin scars. The ability of hyperdilute Botox® Cosmetic to improve overall skin
quality is likely optimized when it is injected uniformly in hyper-diluted small aliquots in
order to "saturate" the dermis. We propose to prepare Botox® Cosmetic in a manner that is
approximately 4 times more dilute compared to the typical Botox® Cosmetic preparation. A 4x4
centimeter area located in the mid-cheek adjacent to the nose will be injected with
hyperdilute Botox® Cosmetic. Botox® Cosmetic is not FDA-approved for this use. A maximum of
15 subjects will participate in this study, all of whom will receive injections of Botox®
Cosmetic during the course of this study.
This study is a randomized, placebo-controlled, and double-masked study. This means neither
the study doctor nor participant know the experimental agent (e.g., 0.9% saline solution and
hyperdiluted Botox® Cosmetic) injected on each side of the patients' faces. The study will
last for a total of 75 days. Evaluation of the study is based on the analysis of photographic
images obtained during the study.
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