Subjects Requesting and Requiring Facial Rejuvenation With Neurotoxins and/or Hyaluronic Acid Fillers Clinical Trial
Official title:
A Post-market, Randomized Study to Assess the Efficacy of Skin Rejuvenation Therapy in Combination With Neurotoxin and Full Facial Filler Treatments
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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