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A Study to Assess the Efficacy of Skin Rejuvenation Therapy in Combination With Neurotoxin and Full Facial Filler Treatments

DeNova Research · 2015
ClinicalTrials.gov · Datasets · License: Public Domain · 2015
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20 female subjects, between the ages of 25 and 60, who request a full facial rejuvenation treatment, meet all the inclusion and none of the exclusion criteria, and have signed a written informed consent, will be enrolled. Subjects will be divided randomly into two treatment groups: 1. Group A: subjects will use a basic skin care regime following a full facial rejuvenation with hyaluronic acid soft-tissue filler and botulinum neurotoxin. 2. Group B: subjects will use the Nu-Derm® system following a full facial rejuvenation with hyaluronic acid soft-tissue filler and botulinum neurotoxin. The study consists of 5 visits: Baseline/Screening Assessments (Visit 1), Treatment (Visit 2), Two-Week Evaluation (Visit 3), Six-Week Evaluation (Visit 4), and Twelve-Week Evaluation (Visit 5). Changes in the subjects' quality of skin will be determined by the PI's assessment of skin tone (dyschromia), elasticity (firmness), texture (smoothness), radiance, and wrinkling as well as the global aesthetic improvement at 6 and 12 weeks following neurotoxin and hyaluronic acid treatments. The PI will be blind to the group assignment of the subjects. Subjects' satisfaction with treatments and their quality of skin will be determined through a self-evaluation at 6 and 12 weeks following neurotoxin and hyaluronic acid treatments. The impact of treatments on subjects' state self-esteem will also be assessed at 6 and 12 weeks following the treatments.
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