Facial Rejuvenation With Neurotoxins and/or Hyaluronic Acid Fillers
Conditions
Brief summary
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.
Interventions
OTHERBasic Skin Care
Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®)
OTHERActive 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®)
Sponsors
DeNova Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject is a female between the ages of 21 and 60; * Subject requires a full facial rejuvenation with a HA soft tissue filler and/or botulinum neurotoxin, per judgment of the PI or designee; * Subject is willing and able to provide written informed consent prior to the performance of any study related procedure; * Subject is willing and able to comply with the protocol requirements; and * Subject is willing and able to provide written photo consent and adhere to the photography and video procedures such as removal of jewelry and makeup.
Exclusion criteria
* Subjects who have received any facial filler in the 12-month or neurotoxin treatments in the 4-month period prior to enrollment; * Previous treatment with any resurfacing facial aesthetic procedure (e.g. deep chemical peeling and laser treatments) within the 12-month period prior to enrollment; * Previous treatment with photo rejuvenation therapy within the 6-month period prior to enrollment; * Subjects who plan to undergo facial cosmetic surgery or any aesthetic procedure (e.g. neurotoxins, dermal fillers, laser treatments, and chemical peels), which are not specified in this protocol, during the course of the study; * A known allergy or sensitivity to any component of the study ingredients; * Use of systemic steroids or anticoagulation medications; * Subjects with a history of bleeding disorders; * Subjects with severe allergies manifested by a history of anaphylaxis or presence of multiple severe allergies; * Subjects with hypersensitivity to botulinum neurotoxin; * Subject with allergies to gram positive bacterial proteins; * Sensitivity to sulfides; * Subjects with allergy to cow's milk protein; * Subjects with previous history of sensitivity to amide type local anesthetics; * Subject with surgical alterations to the facial anatomy or marked facial asymmetry; * Inflammation or infection at the injection site(s); * Subjects with a history of eyelid or eyebrow ptosis; * Excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin; * Subjects with neuromuscular disorders; * Use of anticholinergic, aminoglycosides or other agents that interfere with neuromuscular transmission (e.g., curare-like agents), or muscle relaxants; * Subjects with immunodeficiencies such as HIV, lupus, scleroderma, and systemic infections; * Pregnant, nursing, or sexually active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception (e.g., barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence); * Current history of chronic drug or alcohol abuse; * Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study product; * Subjects who, in the investigator's opinion, have a history of poor cooperation, non-compliance with medical treatment, or unreliability; and * Enrollment in any active study involving the use of investigational devices or drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| C-GAIS by the PI or Designee | Approximately 3 months from the baseline visit | 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 |
| SQA by the PI or Designee | Approximately 3 months from the baseline visit | 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 1. \- poor elasticity 2. \- fair elasticity 3. \- good elasticity 4. \- firm Texture (Smoothness) 0 - severe 1. \- moderate to severe 2. \- moderate 3. \- mild 4. \- none Radiance 0 - severe dullness 1. \- moderate to severe dullness 2. \- moderate dullness 3. \- mild dullness 4. \- radiant All scores with a higher number indicate favorable results All scores with a lower number indicate less favorable results |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Face-Q by Subjects | Final assessment is approximately 3 months from the baseline visit | 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 |
| SSES by Subjects | Final assessment is approximately 3 months from the baseline visit | 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 |
| FIQ by Blinded Evaluators | At the conclusion of study assessments (approximately 3 months from the baseline visit) | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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®) | 10 |
| 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®) | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Active Skin Care | Basic Skin Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 2 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 8 Participants | 15 Participants |
| Age, Continuous | 54.3 years | 54.3 years | 54.3 years |
| Region of Enrollment United States | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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
Time frame: Approximately 3 months from the baseline visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Basic Skin Care | C-GAIS by the PI or Designee | Visit 7 | 1.22 units on a scale | Standard Deviation 0.441 |
| Basic Skin Care | C-GAIS by the PI or Designee | Visit 8/9 | 1.75 units on a scale | Standard Deviation 0.886 |
| Active Skin Care | C-GAIS by the PI or Designee | Visit 7 | 2.13 units on a scale | Standard Deviation 0.835 |
| Active Skin Care | C-GAIS by the PI or Designee | Visit 8/9 | 2.75 units on a scale | Standard Deviation 0.787 |
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 1. \- poor elasticity 2. \- fair elasticity 3. \- good elasticity 4. \- firm Texture (Smoothness) 0 - severe 1. \- moderate to severe 2. \- moderate 3. \- mild 4. \- none Radiance 0 - severe dullness 1. \- moderate to severe dullness 2. \- moderate dullness 3. \- mild dullness 4. \- radiant All scores with a higher number indicate favorable results All scores with a lower number indicate less favorable results
Time frame: Approximately 3 months from the baseline visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Basic Skin Care | SQA by the PI or Designee | Tone - Visit 1 | 1.44 units on a scale | Standard Deviation 0.527 |
| Basic Skin Care | SQA by the PI or Designee | Tone - Visit 7 | 1.78 units on a scale | Standard Deviation 0.667 |
| Basic Skin Care | SQA by the PI or Designee | Tone - Visit 8/9 | 2.88 units on a scale | Standard Deviation 0.641 |
| Basic Skin Care | SQA by the PI or Designee | Elasticity - Visit 1 | 1.33 units on a scale | Standard Deviation 0.5 |
| Basic Skin Care | SQA by the PI or Designee | Elasticity - Visit 7 | 2.33 units on a scale | Standard Deviation 0.5 |
| Basic Skin Care | SQA by the PI or Designee | Elasticity - Visit 8/9 | 2.75 units on a scale | Standard Deviation 0.707 |
| Basic Skin Care | SQA by the PI or Designee | Texture - Visit 1 | 1.11 units on a scale | Standard Deviation 0.601 |
| Basic Skin Care | SQA by the PI or Designee | Texture - Visit 7 | 2.33 units on a scale | Standard Deviation 0.5 |
| Basic Skin Care | SQA by the PI or Designee | Texture - Visit 8/9 | 2.88 units on a scale | Standard Deviation 0.835 |
| Basic Skin Care | SQA by the PI or Designee | Radiance - Visit 1 | 0.88 units on a scale | Standard Deviation 0.354 |
| Basic Skin Care | SQA by the PI or Designee | Radiance - Visit 7 | 2.25 units on a scale | Standard Deviation 0.707 |
| Basic Skin Care | SQA by the PI or Designee | Radiance - Visit 8/9 | 3.00 units on a scale | Standard Deviation 0.926 |
| Active Skin Care | SQA by the PI or Designee | Radiance - Visit 7 | 3.25 units on a scale | Standard Deviation 0.886 |
| Active Skin Care | SQA by the PI or Designee | Tone - Visit 1 | 1.20 units on a scale | Standard Deviation 0.422 |
| Active Skin Care | SQA by the PI or Designee | Texture - Visit 1 | 1.10 units on a scale | Standard Deviation 0.316 |
| Active Skin Care | SQA by the PI or Designee | Tone - Visit 7 | 2.75 units on a scale | Standard Deviation 0.707 |
| Active Skin Care | SQA by the PI or Designee | Radiance - Visit 1 | 1.0 units on a scale | Standard Deviation 0 |
| Active Skin Care | SQA by the PI or Designee | Tone - Visit 8/9 | 3.14 units on a scale | Standard Deviation 0.69 |
| Active Skin Care | SQA by the PI or Designee | Texture - Visit 7 | 3.25 units on a scale | Standard Deviation 0.886 |
| Active Skin Care | SQA by the PI or Designee | Elasticity - Visit 1 | 1.30 units on a scale | Standard Deviation 0.483 |
| Active Skin Care | SQA by the PI or Designee | Radiance - Visit 8/9 | 3.71 units on a scale | Standard Deviation 0.488 |
| Active Skin Care | SQA by the PI or Designee | Elasticity - Visit 7 | 3.25 units on a scale | Standard Deviation 0.886 |
| Active Skin Care | SQA by the PI or Designee | Texture - Visit 8/9 | 3.71 units on a scale | Standard Deviation 0.488 |
| Active Skin Care | SQA by the PI or Designee | Elasticity - Visit 8/9 | 3.57 units on a scale | Standard Deviation 0.535 |
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
Time frame: Final assessment is approximately 3 months from the baseline visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Basic Skin Care | Face-Q by Subjects | Aging Appearance Appraisal - V8/9 | 1.45 units on a scale | Standard Deviation 0.835 |
| Basic Skin Care | Face-Q by Subjects | Satisfaction with Skin - V7 | 3.27 units on a scale | Standard Deviation 0.667 |
| Basic Skin Care | Face-Q by Subjects | Age Appraisal-VAS - V5 | -2 units on a scale | Standard Deviation 0.354 |
| Basic Skin Care | Face-Q by Subjects | Satisfaction with Facial Appearance Overall - V7 | 3.08 units on a scale | Standard Deviation 0.5 |
| Basic Skin Care | Face-Q by Subjects | Age Appraisal-VAS - V7 | -2.22 units on a scale | Standard Deviation 0.707 |
| Basic Skin Care | Face-Q by Subjects | Satisfaction with Skin - V5 | 3.21 units on a scale | Standard Deviation 0.88 |
| Basic Skin Care | Face-Q by Subjects | Age Appraisal-VAS - V8/9 | -5.38 units on a scale | Standard Deviation 0.926 |
| Basic Skin Care | Face-Q by Subjects | Satisfaction with Facial Appearance Overall - V8/9 | 3.46 units on a scale | Standard Deviation 0.707 |
| Basic Skin Care | Face-Q by Subjects | Psychological Well-Being - V7 | 3.52 units on a scale | Standard Deviation 0.552 |
| Basic Skin Care | Face-Q by Subjects | Satisfaction with Skin - V8/9 | 3.6 units on a scale | Standard Deviation 0.641 |
| Basic Skin Care | Face-Q by Subjects | Psychological Well-Being - V8/9 | 3.81 units on a scale | Standard Deviation 0.699 |
| Basic Skin Care | Face-Q by Subjects | Aging Appearance Appraisal - V5 | 2.22 units on a scale | Standard Deviation 0.601 |
| Basic Skin Care | Face-Q by Subjects | Social Function - V5 | 3.51 units on a scale | Standard Deviation 0.553 |
| Basic Skin Care | Face-Q by Subjects | Psychological Well-Being - V5 | 3.5 units on a scale | Standard Deviation 0.568 |
| Basic Skin Care | Face-Q by Subjects | Social Function - V7 | 3.56 units on a scale | Standard Deviation 0.878 |
| Basic Skin Care | Face-Q by Subjects | Aging Appearance Appraisal - V7 | 2.08 units on a scale | Standard Deviation 0.5 |
| Basic Skin Care | Face-Q by Subjects | Social Function - V8/9 | 3.67 units on a scale | Standard Deviation 0.787 |
| Basic Skin Care | Face-Q by Subjects | Satisfaction with Facial Appearance Overall - V5 | 3.14 units on a scale | Standard Deviation 0.5 |
| Active Skin Care | Face-Q by Subjects | Social Function - V8/9 | 3.57 units on a scale | Standard Deviation 0.477 |
| Active Skin Care | Face-Q by Subjects | Satisfaction with Skin - V5 | 3.54 units on a scale | Standard Deviation 0.778 |
| Active Skin Care | Face-Q by Subjects | Satisfaction with Skin - V7 | 3.29 units on a scale | Standard Deviation 0.787 |
| Active Skin Care | Face-Q by Subjects | Satisfaction with Skin - V8/9 | 3.18 units on a scale | Standard Deviation 0.69 |
| Active Skin Care | Face-Q by Subjects | Satisfaction with Facial Appearance Overall - V5 | 3.13 units on a scale | Standard Deviation 0.483 |
| Active Skin Care | Face-Q by Subjects | Satisfaction with Facial Appearance Overall - V7 | 3.06 units on a scale | Standard Deviation 0.886 |
| Active Skin Care | Face-Q by Subjects | Satisfaction with Facial Appearance Overall - V8/9 | 3.1 units on a scale | Standard Deviation 0.535 |
| Active Skin Care | Face-Q by Subjects | Aging Appearance Appraisal - V5 | 1.79 units on a scale | Standard Deviation 0.316 |
| Active Skin Care | Face-Q by Subjects | Aging Appearance Appraisal - V7 | 1.88 units on a scale | Standard Deviation 0.886 |
| Active Skin Care | Face-Q by Subjects | Aging Appearance Appraisal - V8/9 | 1.61 units on a scale | Standard Deviation 0.488 |
| Active Skin Care | Face-Q by Subjects | Age Appraisal-VAS - V5 | -3 units on a scale | Standard Deviation 0.5 |
| Active Skin Care | Face-Q by Subjects | Age Appraisal-VAS - V7 | -3.13 units on a scale | Standard Deviation 0.886 |
| Active Skin Care | Face-Q by Subjects | Age Appraisal-VAS - V8/9 | -3.57 units on a scale | Standard Deviation 0.488 |
| Active Skin Care | Face-Q by Subjects | Psychological Well-Being - V7 | 3.66 units on a scale | Standard Deviation 0.59 |
| Active Skin Care | Face-Q by Subjects | Psychological Well-Being - V8/9 | 3.8 units on a scale | Standard Deviation 0.658 |
| Active Skin Care | Face-Q by Subjects | Social Function - V5 | 3.53 units on a scale | Standard Deviation 0.633 |
| Active Skin Care | Face-Q by Subjects | Social Function - V7 | 3.58 units on a scale | Standard Deviation 0.925 |
| Active Skin Care | Face-Q by Subjects | Psychological Well-Being - V5 | 3.54 units on a scale | Standard Deviation 0.526 |
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
Time frame: At the conclusion of study assessments (approximately 3 months from the baseline visit)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Basic Skin Care | FIQ by Blinded Evaluators | Social skills - Before | 4.9525 units on a scale | Standard Deviation 0.79094 |
| Basic Skin Care | FIQ by Blinded Evaluators | Social skills - After | 5.9136 units on a scale | Standard Deviation 0.6401 |
| Basic Skin Care | FIQ by Blinded Evaluators | Academic Performance - Before | 5.3400 units on a scale | Standard Deviation 0.83351 |
| Basic Skin Care | FIQ by Blinded Evaluators | Academic Performance - After | 6.1550 units on a scale | Standard Deviation 0.48823 |
| Basic Skin Care | FIQ by Blinded Evaluators | Dating success - Before | 4.6700 units on a scale | Standard Deviation 1.21824 |
| Basic Skin Care | FIQ by Blinded Evaluators | Dating success - After | 5.5470 units on a scale | Standard Deviation 0.85017 |
| Basic Skin Care | FIQ by Blinded Evaluators | Occupational success - Before | 5.3350 units on a scale | Standard Deviation 0.93159 |
| Basic Skin Care | FIQ by Blinded Evaluators | Occupational success - After | 6.0723 units on a scale | Standard Deviation 0.57428 |
| Basic Skin Care | FIQ by Blinded Evaluators | Attractiveness - Before | 4.7225 units on a scale | Standard Deviation 1.27725 |
| Basic Skin Care | FIQ by Blinded Evaluators | Attractiveness - After | 5.7758 units on a scale | Standard Deviation 1.03805 |
| Basic Skin Care | FIQ by Blinded Evaluators | Financial Success - Before | 5.3025 units on a scale | Standard Deviation 0.92139 |
| Basic Skin Care | FIQ by Blinded Evaluators | Financial Success - After | 6.0309 units on a scale | Standard Deviation 0.61463 |
| Basic Skin Care | FIQ by Blinded Evaluators | Relationship success - Before | 5.0850 units on a scale | Standard Deviation 0.96094 |
| Basic Skin Care | FIQ by Blinded Evaluators | Relationship success - After | 5.9597 units on a scale | Standard Deviation 0.69371 |
| Basic Skin Care | FIQ by Blinded Evaluators | Athletic success - Before | 4.6475 units on a scale | Standard Deviation 1.31627 |
| Basic Skin Care | FIQ by Blinded Evaluators | Athletic success - After | 5.4897 units on a scale | Standard Deviation 0.9688 |
| Active Skin Care | FIQ by Blinded Evaluators | Athletic success - After | 5.7467 units on a scale | Standard Deviation 1.67741 |
| Active Skin Care | FIQ by Blinded Evaluators | Social skills - Before | 5.0600 units on a scale | Standard Deviation 0.83857 |
| Active Skin Care | FIQ by Blinded Evaluators | Attractiveness - Before | 4.9467 units on a scale | Standard Deviation 1.07574 |
| Active Skin Care | FIQ by Blinded Evaluators | Social skills - After | 6.3333 units on a scale | Standard Deviation 1.67975 |
| Active Skin Care | FIQ by Blinded Evaluators | Relationship success - Before | 5.2167 units on a scale | Standard Deviation 0.76078 |
| Active Skin Care | FIQ by Blinded Evaluators | Academic Performance - Before | 5.3900 units on a scale | Standard Deviation 0.78095 |
| Active Skin Care | FIQ by Blinded Evaluators | Attractiveness - After | 6.0867 units on a scale | Standard Deviation 1.9509 |
| Active Skin Care | FIQ by Blinded Evaluators | Academic Performance - After | 6.2800 units on a scale | Standard Deviation 1.63815 |
| Active Skin Care | FIQ by Blinded Evaluators | Athletic success - Before | 4.6767 units on a scale | Standard Deviation 1.03115 |
| Active Skin Care | FIQ by Blinded Evaluators | Dating success - Before | 5.0367 units on a scale | Standard Deviation 0.99995 |
| Active Skin Care | FIQ by Blinded Evaluators | Financial Success - Before | 5.3567 units on a scale | Standard Deviation 0.81363 |
| Active Skin Care | FIQ by Blinded Evaluators | Dating success - After | 6.1433 units on a scale | Standard Deviation 1.85263 |
| Active Skin Care | FIQ by Blinded Evaluators | Relationship success - After | 6.3233 units on a scale | Standard Deviation 1.70127 |
| Active Skin Care | FIQ by Blinded Evaluators | Occupational success - Before | 5.5233 units on a scale | Standard Deviation 0.77835 |
| Active Skin Care | FIQ by Blinded Evaluators | Financial Success - After | 6.2467 units on a scale | Standard Deviation 1.58249 |
| Active Skin Care | FIQ by Blinded Evaluators | Occupational success - After | 6.3967 units on a scale | Standard Deviation 1.58576 |
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
Time frame: Final assessment is approximately 3 months from the baseline visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Basic Skin Care | SSES by Subjects | Baseline | 80.5 units on a scale | Standard Deviation 0.527 |
| Basic Skin Care | SSES by Subjects | Visit 7 | 79 units on a scale | Standard Deviation 0.886 |
| Basic Skin Care | SSES by Subjects | Visit 8/9 | 84 units on a scale | Standard Deviation 0.641 |
| Active Skin Care | SSES by Subjects | Baseline | 78.5 units on a scale | Standard Deviation 0.422 |
| Active Skin Care | SSES by Subjects | Visit 7 | 80 units on a scale | Standard Deviation 0.707 |
| Active Skin Care | SSES by Subjects | Visit 8/9 | 85 units on a scale | Standard Deviation 0.69 |