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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Basic Skin Care | Placebo Comparator | Subjects will use a basic skin care regime following a full facial rejuvenation with hyaluronic acid soft-tissue filler and botulinum neurotoxin. |
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| Group B: NuDermĀ® System | Experimental | Subjects will use the Nu-DermĀ® system following a full facial rejuvenation with hyaluronic acid soft-tissue filler and botulinum neurotoxin. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NuDermĀ® System | Other | The Nu-DermĀ® System (Valeant Pharmaceuticals North America, LLP) is a skin care system that helps correct and reduce visible signs of aging such as age spots, rough skin, erythema, sallowness, and hyperpigmentation. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall aesthetic improvements | The primary objective of this study is to examine the effect of skin rejuvenation therapy in combination with full facial rejuvenation, via neurotoxin or HA soft-tissue filler, on the overall aesthetic improvements. | 90 Days |
| Measure | Description | Time Frame |
|---|---|---|
| State Self-Esteem | The secondary objective of this study is to assess the impact of skin quality and aesthetic improvements on short-term self-esteem. | 90 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven H Dayan, MD | DeNova Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DeNova research | Chicago | Illinois | 60611 | United States |
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| Placebo | Other | Basic skin care regimen |
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