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The primary objective of this study is to determine the efficacy of Sensi Peel®, Rejuvenating Serum, and the C&E Strength Max skin care products in subjects who undergo full facial rejuvenation, with a botulinum neurotoxin A and/or hyaluronic acid filler, in improving the appearance of the skin, patient satisfaction with aesthetic appearance, and the projected first impressions.
The secondary objective of this study is to examine patient satisfaction with the continuous use of Sensi Peel®, Rejuvenating Serum, and the C&E Strength Max products.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Basic Skin Care | Placebo Comparator | Subjects use a basic skin care regimen. |
|
| Active Skin Care | Active Comparator | Subjects use the Sensi Peel®, Rejuvenating Serum, and C&E Strength Max skin care products in additional to a basic skin care regiment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Basic Skin Care | Other | Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®) |
|
| Measure | Description | Time Frame |
|---|---|---|
| C-GAIS by the PI or Designee | Global aesthetic improvement in subjects is assessed by the PI/designee using the Global Aesthetic Improvement Scale (C-GAIS). Clinical-Global Aesthetic Improvement Scale (C-GAIS): 3 (Very Much Improved) 2 (Much Improved) 1 (Improved) 0 (No change) -1 (Worse) Scores closer to 3 show a more favorable outcome Scores closer to -1 show a less favorable outcome | Approximately 3 months from the baseline visit |
| SQA by the PI or Designee | The quality of subjects' skin is assessed by PI/designee using the Skin Quality Assessment (SQA) Skin Quality Assessment (SQA): Tone (dyschromia) 0 - severe unevenness 1- moderate to severe unevenness 2 - moderate unevenness 3 - mild unevenness 4 - even Elasticity (Firmness) 0 - Very poor elasticity
Texture (Smoothness) 0 - severe
Radiance 0 - severe dullness
All scores with a higher number indicate favorable results All scores with a lower number indicate less favorable results | Approximately 3 months from the baseline visit |
| Measure | Description | Time Frame |
|---|---|---|
| Face-Q by Subjects | Subjects self-evaluation of their quality of skin, age-appraisal, and social and psychological assessments are performed using the Face-Q questionnaire. FACE-Q (Satisfaction with Skin): scored between 1-4 for 12 questions. Total score closer to 48 indicates a more favorable outcome FACE-Q (Satisfaction with Facial Appearance Overall): scored between 1-4 for 10 questions. Total score closer to 40 indicates a more favorable outcome FACE-Q (Aging Appearance Appraisal): scored between 1-4 for 7 questions. Total score closer to 28 indicates a more favorable outcome FACE-Q (Age Appraisal-VAS): scored between -15 to +15. Total score closer to -15 indicates a more favorable outcome FACE-Q (Psychological Well-Being): scored between 1-4 for 10 questions. Total score closer to 40 indicates a more favorable outcome FACE-Q (Social Function):scored between 1-4 for 8 questions. Total score closer to 32 indicates a more favorable outcome |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Basic Skin Care | Subjects use a basic skin care regimen. Basic Skin Care: Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®) |
| FG001 | Active Skin Care | Subjects use the Sensi Peel®, Rejuvenating Serum, and C&E Strength Max skin care products in additional to a basic skin care regiment. Active Skin Care: Sensi Peel®, Rejuvenating Serum, and C&E Strength Max skin care products (PCA SKIN®) in addition to the Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Basic Skin Care | Subjects use a basic skin care regimen. Basic Skin Care: Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®) |
| BG001 | Active Skin Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | C-GAIS by the PI or Designee | Global aesthetic improvement in subjects is assessed by the PI/designee using the Global Aesthetic Improvement Scale (C-GAIS). Clinical-Global Aesthetic Improvement Scale (C-GAIS): 3 (Very Much Improved) 2 (Much Improved) 1 (Improved) 0 (No change) -1 (Worse) Scores closer to 3 show a more favorable outcome Scores closer to -1 show a less favorable outcome | Posted | Mean | Standard Deviation | units on a scale | Approximately 3 months from the baseline visit |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Basic Skin Care | Subjects use a basic skin care regimen. Basic Skin Care: Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Dayan, MD | DeNova Research | 3123352070 | sdayan@drdayan.com |
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| Active Skin Care | Other | Sensi Peel®, Rejuvenating Serum, and C&E Strength Max skin care products (PCA SKIN®) in addition to the Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®) |
|
|
| Final assessment is approximately 3 months from the baseline visit |
| SSES by Subjects | Changes in self-esteem is assessed using the State Self-Esteem Scale (SSES): performance, social, and appearance State Self-Esteem Scale (SSES): scored between 1-5 for 20 questions. Scores closer to 100 indicate a more favorable outcome | Final assessment is approximately 3 months from the baseline visit |
| FIQ by Blinded Evaluators | The projected first impressions are assessed by blinded evaluators using the First Impression Questionnaire (FIQ). First Impression Questionnaire (FIQ): scored between 1-10 for 8 questions. Scores closer to 10 for each question indicate a more favorable outcome | At the conclusion of study assessments (approximately 3 months from the baseline visit) |
Subjects use the Sensi Peel®, Rejuvenating Serum, and C&E Strength Max skin care products in additional to a basic skin care regiment.
Active Skin Care: Sensi Peel®, Rejuvenating Serum, and C&E Strength Max skin care products (PCA SKIN®) in addition to the Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®)
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects use the Sensi Peel®, Rejuvenating Serum, and C&E Strength Max skin care products in additional to a basic skin care regiment.
Active Skin Care: Sensi Peel®, Rejuvenating Serum, and C&E Strength Max skin care products (PCA SKIN®) in addition to the Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®)
|
|
| Primary | SQA by the PI or Designee | The quality of subjects' skin is assessed by PI/designee using the Skin Quality Assessment (SQA) Skin Quality Assessment (SQA): Tone (dyschromia) 0 - severe unevenness 1- moderate to severe unevenness 2 - moderate unevenness 3 - mild unevenness 4 - even Elasticity (Firmness) 0 - Very poor elasticity
Texture (Smoothness) 0 - severe
Radiance 0 - severe dullness
All scores with a higher number indicate favorable results All scores with a lower number indicate less favorable results | Posted | Mean | Standard Deviation | units on a scale | Approximately 3 months from the baseline visit |
|
|
|
| Secondary | Face-Q by Subjects | Subjects self-evaluation of their quality of skin, age-appraisal, and social and psychological assessments are performed using the Face-Q questionnaire. FACE-Q (Satisfaction with Skin): scored between 1-4 for 12 questions. Total score closer to 48 indicates a more favorable outcome FACE-Q (Satisfaction with Facial Appearance Overall): scored between 1-4 for 10 questions. Total score closer to 40 indicates a more favorable outcome FACE-Q (Aging Appearance Appraisal): scored between 1-4 for 7 questions. Total score closer to 28 indicates a more favorable outcome FACE-Q (Age Appraisal-VAS): scored between -15 to +15. Total score closer to -15 indicates a more favorable outcome FACE-Q (Psychological Well-Being): scored between 1-4 for 10 questions. Total score closer to 40 indicates a more favorable outcome FACE-Q (Social Function):scored between 1-4 for 8 questions. Total score closer to 32 indicates a more favorable outcome | Posted | Mean | Standard Deviation | units on a scale | Final assessment is approximately 3 months from the baseline visit |
|
|
|
| Secondary | SSES by Subjects | Changes in self-esteem is assessed using the State Self-Esteem Scale (SSES): performance, social, and appearance State Self-Esteem Scale (SSES): scored between 1-5 for 20 questions. Scores closer to 100 indicate a more favorable outcome | Posted | Mean | Standard Deviation | units on a scale | Final assessment is approximately 3 months from the baseline visit |
|
|
|
| Secondary | FIQ by Blinded Evaluators | The projected first impressions are assessed by blinded evaluators using the First Impression Questionnaire (FIQ). First Impression Questionnaire (FIQ): scored between 1-10 for 8 questions. Scores closer to 10 for each question indicate a more favorable outcome | Posted | Mean | Standard Deviation | units on a scale | At the conclusion of study assessments (approximately 3 months from the baseline visit) |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Active Skin Care | Subjects use the Sensi Peel®, Rejuvenating Serum, and C&E Strength Max skin care products in additional to a basic skin care regiment. Active Skin Care: Sensi Peel®, Rejuvenating Serum, and C&E Strength Max skin care products (PCA SKIN®) in addition to the Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®) | 0 | 10 | 0 | 10 | 0 | 10 |
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| Tone - Visit 8/9 |
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| Elasticity - Visit 1 |
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| Elasticity - Visit 7 |
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| Elasticity - Visit 8/9 |
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| Texture - Visit 1 |
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| Texture - Visit 7 |
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| Texture - Visit 8/9 |
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| Radiance - Visit 1 |
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| Radiance - Visit 7 |
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| Radiance - Visit 8/9 |
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| Satisfaction with Skin - V8/9 |
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| Satisfaction with Facial Appearance Overall - V5 |
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| Satisfaction with Facial Appearance Overall - V7 |
|
| Satisfaction with Facial Appearance Overall - V8/9 |
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| Aging Appearance Appraisal - V5 |
|
| Aging Appearance Appraisal - V7 |
|
| Aging Appearance Appraisal - V8/9 |
|
| Age Appraisal-VAS - V5 |
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| Age Appraisal-VAS - V7 |
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| Age Appraisal-VAS - V8/9 |
|
| Psychological Well-Being - V5 |
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| Psychological Well-Being - V7 |
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| Psychological Well-Being - V8/9 |
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| Social Function - V5 |
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| Social Function - V7 |
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| Social Function - V8/9 |
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| Visit 8/9 |
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| Academic Performance - Before |
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| Academic Performance - After |
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| Dating success - Before |
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| Dating success - After |
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| Occupational success - Before |
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| Occupational success - After |
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| Attractiveness - Before |
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| Attractiveness - After |
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| Financial Success - Before |
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| Financial Success - After |
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| Relationship success - Before |
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| Relationship success - After |
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| Athletic success - Before |
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| Athletic success - After |
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