Nasolabial Folds
Conditions
Brief summary
This study has been designed to evaluate the safety of Sculptra Aesthetic as a single regimen for correction of Nasolabial Fold (NLF) contour deficiencies after changes in reconstitution and injection procedures compared to the approved label.
Interventions
DEVICESculptra Aesthetic 8ml
Treatment of nasolabial folds
DEVICESculptra Aesthetic 5ml
Treatment of nasolabial folds
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Intent to undergo correction of both left and right NLFs with a Wrinkle Assessment Scale (WAS) score of greater than or equal to 2 (shallow wrinkles) to less than or equal to 4 (deep wrinkles) as assessed on Day 1 (and also at screening, if screening was performed prior to Day 1) by the Blinded Evaluator. A one grade difference between sides is allowed at inclusion.
Exclusion criteria
* Previous tissue augmenting therapy, contouring or revitalization treatment in or near the treatment area with any filler prior to Baseline visit. 1. Collagen, Hyaluronic Acid- 12 months 2. Calcium Hydroxyapatite (CaHa), Poly-L-lactic Acid (PLLA) or permanent (non-biodegradable)- Prohibited * Known/previous allergy or hypersensitivity to any of the Sculptra Aesthetic constituents.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Wrinkle Assessment Scale (WAS) Score | 48 weeks | The WAS is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. Scoring of NLF wrinkle severity (grades 0-5, with 0 representing no wrinkles and 5 representing very deep wrinkles, redundant fold) was based on visual live assessment by the Blinded Evaluator at defined timepoints and not on a comparison to the baseline appearance. Effectiveness is defined as change from baseline on both sides of the face using WAS at 48 Weeks after the first treatment session. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Responder Rate Based on Global Aesthetic Improvement Scale, Subject Assessment | Weeks 16, 24, 32, 40, and 48. | Responders defined as at least improved (improved, much improved, very much improved) as assessed by the subject |
| Responder Rate Based on the Global Aesthetic Improvement Scale, Treating Investigator Assessment | Weeks 16, 24, 32, 40 and 48 | Responders defined as at least improved (improved, much improved, very much improved) as assessed by the Treating Investigator |
| FACE-Q Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire | Baseline and at weeks 24, 32, 40 and 48 | Subjects' satisfaction using the validated FACE-Q Scale, Rasch-transformed total score (0-100) according to the FACE-Q manual; the higher total score indicated greater subject satisfaction |
| Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 16, 24, 32, 40 and 48 | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. |
| Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 16, 24, 32, 40 and 48 | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. |
| Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 16, 24, 32, 40 and 48 | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. |
| Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 16, 24, 32, 40 and 48 | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. |
| Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 16, 24, 32, 40 and 48 | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. |
| Change in Wrinkle Assessment Scale (WAS) Score | Weeks 16, 24, 32, and 40 | The WAS is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. Scoring of NLF wrinkle severity (grades 0-5, with 0 representing no wrinkles and 5 representing very deep wrinkles, redundant fold) was based on visual live assessment by the Blinded Evaluator at defined timepoints and not on a comparison to the baseline appearance. Effectiveness is defined as change from baseline on both sides of the face as assessed by the Blinded Evaluator using WAS at X weeks |
| Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 16, 24, 32, 40 and 48 | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. |
| Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 16, 24, 32, 40 and 48 | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. |
| Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 16, 24, 32, 40 and 48 | A 5-point subject satisfaction questionnaire with the following responses: Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree, Strongly Disagree. |
| Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 16, 24, 32, 40 and 48 | A 5-point subject satisfaction questionnaire with the following responses: Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree, Strongly Disagree. |
| Subject Satisfaction With Treatment: Would You do the Treatment Again? | Week 16, 24, 32, 40 and 48 | A subject satisfaction question with responses Yes or No. |
| Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend? | Week 16, 24, 32, 40 and 48 | A subject satisfaction question with responses Yes or No. |
| Earliest Time the Subject Reported Feeling Comfortable Returning to Social Engagement Based on Subject Diary Reporting | time in hours from treatment procedure after treatments 1,2,3 and 4 at weeks 0, 4, 8, and 12 | Subjects were asked to complete the following questions in the subject diary: * Did you feel comfortable to return to social engagement today? (Yes or No) * If yes, what was the earliest time you felt comfortable to return to social engagement? (Record date and time \[using 24-hour clock\]) |
| Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 16, 24, 32, 40 and 48 | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Investigational Study Product Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI)
Sculptra Aesthetic 8ml: Treatment of nasolabial folds | 59 |
| Reference Product Injection with Sculptra Aesthetic reconstituted with 5ml SWFI
Sculptra Aesthetic 5ml: Treatment of nasolabial folds | 21 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Investigational Study Product | Total | Reference Product |
|---|---|---|---|
| Age, Continuous | 51.6 years STANDARD_DEVIATION 10.49 | 51.5 years STANDARD_DEVIATION 10.28 | 51.4 years STANDARD_DEVIATION 9.93 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 18 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants | 62 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Type (FST) FST I | 2 Participants | 2 Participants | 0 Participants |
| Fitzpatrick Skin Type (FST) FST II | 11 Participants | 17 Participants | 6 Participants |
| Fitzpatrick Skin Type (FST) FST III | 25 Participants | 37 Participants | 12 Participants |
| Fitzpatrick Skin Type (FST) FST IV | 9 Participants | 11 Participants | 2 Participants |
| Fitzpatrick Skin Type (FST) FST V | 9 Participants | 10 Participants | 1 Participants |
| Fitzpatrick Skin Type (FST) FST VI | 3 Participants | 3 Participants | 0 Participants |
| Region of Enrollment United States | 59 participants | 80 participants | 21 participants |
| Sex: Female, Male Female | 56 Participants | 76 Participants | 20 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 21 |
| other Total, other adverse events | 7 / 59 | 7 / 21 |
| serious Total, serious adverse events | 2 / 59 | 0 / 21 |
Outcome results
Primary
Change in Wrinkle Assessment Scale (WAS) Score
The WAS is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. Scoring of NLF wrinkle severity (grades 0-5, with 0 representing no wrinkles and 5 representing very deep wrinkles, redundant fold) was based on visual live assessment by the Blinded Evaluator at defined timepoints and not on a comparison to the baseline appearance. Effectiveness is defined as change from baseline on both sides of the face using WAS at 48 Weeks after the first treatment session.
Time frame: 48 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Investigational Study Product | Change in Wrinkle Assessment Scale (WAS) Score | Left NLF | -1.3 units on a scale |
| Investigational Study Product | Change in Wrinkle Assessment Scale (WAS) Score | Right NLF | -1.2 units on a scale |
| Reference Product | Change in Wrinkle Assessment Scale (WAS) Score | Left NLF | -1.3 units on a scale |
| Reference Product | Change in Wrinkle Assessment Scale (WAS) Score | Right NLF | -1.3 units on a scale |
Secondary
Change in Wrinkle Assessment Scale (WAS) Score
The WAS is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. Scoring of NLF wrinkle severity (grades 0-5, with 0 representing no wrinkles and 5 representing very deep wrinkles, redundant fold) was based on visual live assessment by the Blinded Evaluator at defined timepoints and not on a comparison to the baseline appearance. Effectiveness is defined as change from baseline on both sides of the face as assessed by the Blinded Evaluator using WAS at X weeks
Time frame: Weeks 16, 24, 32, and 40
Population: Intent-to-Treat Population, Observed cases
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Investigational Study Product | Change in Wrinkle Assessment Scale (WAS) Score | Week 40- Right NLF | -1.2 units on a scale | Standard Deviation 0.78 |
| Investigational Study Product | Change in Wrinkle Assessment Scale (WAS) Score | Week 16- Left NLF | -1.3 units on a scale | Standard Deviation 0.96 |
| Investigational Study Product | Change in Wrinkle Assessment Scale (WAS) Score | Week 16- Right NLF | -1.1 units on a scale | Standard Deviation 0.69 |
| Investigational Study Product | Change in Wrinkle Assessment Scale (WAS) Score | Week 24- Left NLF | -1.2 units on a scale | Standard Deviation 0.94 |
| Investigational Study Product | Change in Wrinkle Assessment Scale (WAS) Score | Week 24- Right NFL | -1.1 units on a scale | Standard Deviation 0.84 |
| Investigational Study Product | Change in Wrinkle Assessment Scale (WAS) Score | Week 32- Left NLF | -1.2 units on a scale | Standard Deviation 1 |
| Investigational Study Product | Change in Wrinkle Assessment Scale (WAS) Score | Week 32- Right NLF | -1.1 units on a scale | Standard Deviation 0.86 |
| Investigational Study Product | Change in Wrinkle Assessment Scale (WAS) Score | Week 40- Left NLF | -1.3 units on a scale | Standard Deviation 0.94 |
| Reference Product | Change in Wrinkle Assessment Scale (WAS) Score | Week 32- Right NLF | -1.3 units on a scale | Standard Deviation 0.97 |
| Reference Product | Change in Wrinkle Assessment Scale (WAS) Score | Week 40- Right NLF | -1.4 units on a scale | Standard Deviation 0.8 |
| Reference Product | Change in Wrinkle Assessment Scale (WAS) Score | Week 24- Right NFL | -1.5 units on a scale | Standard Deviation 0.68 |
| Reference Product | Change in Wrinkle Assessment Scale (WAS) Score | Week 16- Left NLF | -1.5 units on a scale | Standard Deviation 0.81 |
| Reference Product | Change in Wrinkle Assessment Scale (WAS) Score | Week 32- Left NLF | -1.2 units on a scale | Standard Deviation 0.93 |
| Reference Product | Change in Wrinkle Assessment Scale (WAS) Score | Week 16- Right NLF | -1.5 units on a scale | Standard Deviation 0.6 |
| Reference Product | Change in Wrinkle Assessment Scale (WAS) Score | Week 40- Left NLF | -1.4 units on a scale | Standard Deviation 0.86 |
| Reference Product | Change in Wrinkle Assessment Scale (WAS) Score | Week 24- Left NLF | -1.4 units on a scale | Standard Deviation 1.21 |
Secondary
Earliest Time the Subject Reported Feeling Comfortable Returning to Social Engagement Based on Subject Diary Reporting
Subjects were asked to complete the following questions in the subject diary: * Did you feel comfortable to return to social engagement today? (Yes or No) * If yes, what was the earliest time you felt comfortable to return to social engagement? (Record date and time \[using 24-hour clock\])
Time frame: time in hours from treatment procedure after treatments 1,2,3 and 4 at weeks 0, 4, 8, and 12
Population: Intent-to-Treat Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Investigational Study Product | Earliest Time the Subject Reported Feeling Comfortable Returning to Social Engagement Based on Subject Diary Reporting | After treatment 1 | 1.4 time in hours |
| Investigational Study Product | Earliest Time the Subject Reported Feeling Comfortable Returning to Social Engagement Based on Subject Diary Reporting | After treatment 2 | 1.6 time in hours |
| Investigational Study Product | Earliest Time the Subject Reported Feeling Comfortable Returning to Social Engagement Based on Subject Diary Reporting | After treatment 3 | 1.5 time in hours |
| Investigational Study Product | Earliest Time the Subject Reported Feeling Comfortable Returning to Social Engagement Based on Subject Diary Reporting | After treatment 4 | 1.5 time in hours |
| Reference Product | Earliest Time the Subject Reported Feeling Comfortable Returning to Social Engagement Based on Subject Diary Reporting | After treatment 4 | 1.0 time in hours |
| Reference Product | Earliest Time the Subject Reported Feeling Comfortable Returning to Social Engagement Based on Subject Diary Reporting | After treatment 1 | 2 time in hours |
| Reference Product | Earliest Time the Subject Reported Feeling Comfortable Returning to Social Engagement Based on Subject Diary Reporting | After treatment 3 | 1.5 time in hours |
| Reference Product | Earliest Time the Subject Reported Feeling Comfortable Returning to Social Engagement Based on Subject Diary Reporting | After treatment 2 | 1 time in hours |
Secondary
FACE-Q Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire
Subjects' satisfaction using the validated FACE-Q Scale, Rasch-transformed total score (0-100) according to the FACE-Q manual; the higher total score indicated greater subject satisfaction
Time frame: Baseline and at weeks 24, 32, 40 and 48
Population: Intent-to-Treat Population, Observed cases
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Investigational Study Product | FACE-Q Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire | Baseline | 37.8 score on a scale | Standard Deviation 20.89 |
| Investigational Study Product | FACE-Q Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire | Week 32 | 72.4 score on a scale | Standard Deviation 24.44 |
| Investigational Study Product | FACE-Q Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire | Week 24 | 75.3 score on a scale | Standard Deviation 23.1 |
| Investigational Study Product | FACE-Q Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire | Week 48 | 74.3 score on a scale | Standard Deviation 23.6 |
| Investigational Study Product | FACE-Q Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire | Week 40 | 71.3 score on a scale | Standard Deviation 25.31 |
| Reference Product | FACE-Q Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire | Week 48 | 79.9 score on a scale | Standard Deviation 19.39 |
| Reference Product | FACE-Q Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire | Week 24 | 81.2 score on a scale | Standard Deviation 19.83 |
| Reference Product | FACE-Q Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire | Week 32 | 73.2 score on a scale | Standard Deviation 23.8 |
| Reference Product | FACE-Q Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire | Week 40 | 77.2 score on a scale | Standard Deviation 21.33 |
| Reference Product | FACE-Q Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire | Baseline | 39.4 score on a scale | Standard Deviation 16.22 |
Secondary
Responder Rate Based on Global Aesthetic Improvement Scale, Subject Assessment
Responders defined as at least improved (improved, much improved, very much improved) as assessed by the subject
Time frame: Weeks 16, 24, 32, 40, and 48.
Population: Intent-to-Treat Population, observed cases
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Investigational Study Product | Responder Rate Based on Global Aesthetic Improvement Scale, Subject Assessment | Week 16 | 54 Participants |
| Investigational Study Product | Responder Rate Based on Global Aesthetic Improvement Scale, Subject Assessment | Week 24 | 53 Participants |
| Investigational Study Product | Responder Rate Based on Global Aesthetic Improvement Scale, Subject Assessment | Week 32 | 52 Participants |
| Investigational Study Product | Responder Rate Based on Global Aesthetic Improvement Scale, Subject Assessment | Week 40 | 51 Participants |
| Investigational Study Product | Responder Rate Based on Global Aesthetic Improvement Scale, Subject Assessment | Week 48 | 51 Participants |
| Reference Product | Responder Rate Based on Global Aesthetic Improvement Scale, Subject Assessment | Week 40 | 20 Participants |
| Reference Product | Responder Rate Based on Global Aesthetic Improvement Scale, Subject Assessment | Week 16 | 20 Participants |
| Reference Product | Responder Rate Based on Global Aesthetic Improvement Scale, Subject Assessment | Week 32 | 20 Participants |
| Reference Product | Responder Rate Based on Global Aesthetic Improvement Scale, Subject Assessment | Week 48 | 21 Participants |
| Reference Product | Responder Rate Based on Global Aesthetic Improvement Scale, Subject Assessment | Week 24 | 20 Participants |
Secondary
Responder Rate Based on the Global Aesthetic Improvement Scale, Treating Investigator Assessment
Responders defined as at least improved (improved, much improved, very much improved) as assessed by the Treating Investigator
Time frame: Weeks 16, 24, 32, 40 and 48
Population: Intent-to-Treat Population, Observed cases
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Investigational Study Product | Responder Rate Based on the Global Aesthetic Improvement Scale, Treating Investigator Assessment | Week 24 | 58 Participants |
| Investigational Study Product | Responder Rate Based on the Global Aesthetic Improvement Scale, Treating Investigator Assessment | Week 40 | 59 Participants |
| Investigational Study Product | Responder Rate Based on the Global Aesthetic Improvement Scale, Treating Investigator Assessment | Week 32 | 57 Participants |
| Investigational Study Product | Responder Rate Based on the Global Aesthetic Improvement Scale, Treating Investigator Assessment | Week 48 | 57 Participants |
| Investigational Study Product | Responder Rate Based on the Global Aesthetic Improvement Scale, Treating Investigator Assessment | Week 16 | 56 Participants |
| Reference Product | Responder Rate Based on the Global Aesthetic Improvement Scale, Treating Investigator Assessment | Week 48 | 21 Participants |
| Reference Product | Responder Rate Based on the Global Aesthetic Improvement Scale, Treating Investigator Assessment | Week 16 | 21 Participants |
| Reference Product | Responder Rate Based on the Global Aesthetic Improvement Scale, Treating Investigator Assessment | Week 24 | 21 Participants |
| Reference Product | Responder Rate Based on the Global Aesthetic Improvement Scale, Treating Investigator Assessment | Week 32 | 21 Participants |
| Reference Product | Responder Rate Based on the Global Aesthetic Improvement Scale, Treating Investigator Assessment | Week 40 | 21 Participants |
Secondary
Satisfaction With Treatment: Does the Treatment Make You Look Younger?
A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.
Time frame: Week 16, 24, 32, 40 and 48
Population: ITT- observed cases
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Investigational Study Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 40 | Satisfied | 26 Participants |
| Investigational Study Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 24 | Very Dissatisfied | 0 Participants |
| Investigational Study Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 48 | Dissatisfied | 3 Participants |
| Investigational Study Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 32 | Very Satisfied | 25 Participants |
| Investigational Study Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 16 | Very Satisfied | 29 Participants |
| Investigational Study Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 32 | Satisfied | 18 Participants |
| Investigational Study Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 16 | Satisfied | 19 Participants |
| Investigational Study Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 32 | Neutral (not satisfied or dissatisfied) | 12 Participants |
| Investigational Study Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 32 | Dissatisfied | 2 Participants |
| Investigational Study Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 40 | Very Dissatisfied | 1 Participants |
| Investigational Study Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 32 | Very Dissatisfied | 0 Participants |
| Investigational Study Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 16 | Neutral (not satisfied or dissatisfied) | 6 Participants |
| Investigational Study Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 40 | Very Satisfied | 24 Participants |
| Investigational Study Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 24 | Very Satisfied | 22 Participants |
| Investigational Study Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 16 | Dissatisfied | 2 Participants |
| Investigational Study Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 40 | Neutral (not satisfied or dissatisfied) | 6 Participants |
| Investigational Study Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 24 | Satisfied | 28 Participants |
| Investigational Study Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 40 | Dissatisfied | 2 Participants |
| Investigational Study Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 16 | Very Dissatisfied | 1 Participants |
| Investigational Study Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 48 | Very Satisfied | 23 Participants |
| Investigational Study Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 24 | Neutral (not satisfied or dissatisfied) | 6 Participants |
| Investigational Study Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 48 | Satisfied | 25 Participants |
| Investigational Study Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 48 | Neutral (not satisfied or dissatisfied) | 7 Participants |
| Investigational Study Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 48 | Very Dissatisfied | 0 Participants |
| Investigational Study Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 24 | Dissatisfied | 2 Participants |
| Reference Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 48 | Very Dissatisfied | 0 Participants |
| Reference Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 16 | Neutral (not satisfied or dissatisfied) | 0 Participants |
| Reference Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 16 | Dissatisfied | 0 Participants |
| Reference Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 16 | Very Dissatisfied | 0 Participants |
| Reference Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 32 | Neutral (not satisfied or dissatisfied) | 2 Participants |
| Reference Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 40 | Very Dissatisfied | 0 Participants |
| Reference Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 48 | Satisfied | 9 Participants |
| Reference Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 48 | Neutral (not satisfied or dissatisfied) | 2 Participants |
| Reference Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 16 | Satisfied | 10 Participants |
| Reference Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 24 | Very Satisfied | 8 Participants |
| Reference Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 24 | Satisfied | 12 Participants |
| Reference Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 24 | Neutral (not satisfied or dissatisfied) | 0 Participants |
| Reference Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 24 | Dissatisfied | 0 Participants |
| Reference Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 24 | Very Dissatisfied | 0 Participants |
| Reference Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 32 | Very Satisfied | 10 Participants |
| Reference Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 32 | Satisfied | 9 Participants |
| Reference Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 32 | Dissatisfied | 0 Participants |
| Reference Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 32 | Very Dissatisfied | 0 Participants |
| Reference Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 40 | Very Satisfied | 11 Participants |
| Reference Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 40 | Satisfied | 7 Participants |
| Reference Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 40 | Neutral (not satisfied or dissatisfied) | 3 Participants |
| Reference Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 40 | Dissatisfied | 0 Participants |
| Reference Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 48 | Very Satisfied | 10 Participants |
| Reference Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 48 | Dissatisfied | 0 Participants |
| Reference Product | Satisfaction With Treatment: Does the Treatment Make You Look Younger? | Week 16 | Very Satisfied | 11 Participants |
Secondary
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.
Time frame: Week 16, 24, 32, 40 and 48
Population: ITT- observed cases
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 16 | Dissatisfied | 1 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 32 | Very Satisfied | 24 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 16 | Very Satisfied | 23 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 32 | Satisfied | 22 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 16 | Very Dissatisfied | 1 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 32 | Neutral | 10 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 48 | Neutral | 11 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 32 | Dissatisfied | 1 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 24 | Very Satisfied | 17 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 32 | Very Dissatisfied | 0 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 16 | Satisfied | 26 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 40 | Very Satisfied | 23 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 24 | Satisfied | 34 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 40 | Satisfied | 26 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 48 | Satisfied | 20 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 40 | Neutral | 7 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 24 | Neutral | 5 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 40 | Dissatisfied | 2 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 16 | Neutral | 6 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 40 | Very Dissatisfied | 1 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 24 | Dissatisfied | 2 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 48 | Very Satisfied | 25 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 48 | Dissatisfied | 2 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 48 | Very Dissatisfied | 0 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 24 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 48 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 48 | Satisfied | 8 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 48 | Neutral | 2 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 16 | Very Satisfied | 8 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 16 | Satisfied | 12 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 16 | Neutral | 1 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 16 | Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 16 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 24 | Very Satisfied | 7 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 24 | Satisfied | 13 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 24 | Neutral | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 24 | Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 24 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 32 | Very Satisfied | 12 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 32 | Satisfied | 8 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 32 | Neutral | 1 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 32 | Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 32 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 40 | Very Satisfied | 12 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 40 | Satisfied | 6 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 40 | Neutral | 3 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 40 | Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 40 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 48 | Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | Week 48 | Very Satisfied | 11 Participants |
Secondary
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.
Time frame: Week 16, 24, 32, 40 and 48
Population: ITT- observed cases
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 40 | Dissatisfied | 2 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 40 | Satisfied | 23 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 40 | Neutral (not satisfied or dissatisfied) | 9 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 16 | Very satisfied | 21 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 16 | Satisfied | 23 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 16 | Neutral (not satisfied or dissatisfied) | 10 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 16 | Dissatisfied | 2 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 16 | Very Dissatisfied | 1 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 24 | Very satisfied | 19 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 24 | Satisfied | 25 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 24 | Neutral (not satisfied or dissatisfied) | 12 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 24 | Dissatisfied | 2 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 24 | Very Dissatisfied | 0 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 32 | Very satisfied | 25 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 32 | Satisfied | 17 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 32 | Neutral (not satisfied or dissatisfied) | 13 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 32 | Dissatisfied | 2 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 32 | Very Dissatisfied | 0 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 40 | Very satisfied | 24 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 40 | Very Dissatisfied | 1 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 48 | Very satisfied | 20 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 48 | Satisfied | 24 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 48 | Neutral (not satisfied or dissatisfied) | 11 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 48 | Dissatisfied | 3 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 48 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 40 | Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 32 | Very satisfied | 9 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 40 | Satisfied | 6 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 48 | Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 40 | Neutral (not satisfied or dissatisfied) | 4 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 48 | Satisfied | 9 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 16 | Very satisfied | 8 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 32 | Satisfied | 9 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 16 | Satisfied | 12 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 40 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 16 | Neutral (not satisfied or dissatisfied) | 1 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 32 | Neutral (not satisfied or dissatisfied) | 3 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 16 | Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 48 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 16 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 32 | Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 24 | Very satisfied | 8 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 48 | Very satisfied | 9 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 24 | Satisfied | 10 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 32 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 24 | Neutral (not satisfied or dissatisfied) | 2 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 48 | Neutral (not satisfied or dissatisfied) | 3 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 24 | Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 40 | Very satisfied | 11 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | Week 24 | Very Dissatisfied | 0 Participants |
Secondary
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.
Time frame: Week 16, 24, 32, 40 and 48
Population: ITT- observed cases
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 16 | Satisfied | 21 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 32 | Dissatisfied | 4 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 24 | Neutral (not satisfied or dissatisfied) | 11 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 32 | Very Dissatisfied | 0 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 16 | Dissatisfied | 2 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 40 | Very Satisfied | 22 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 24 | Dissatisfied | 3 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 40 | Satisfied | 26 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 16 | Very Satisfied | 24 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 40 | Neutral (not satisfied or dissatisfied) | 7 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 24 | Very Dissatisfied | 0 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 40 | Dissatisfied | 3 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 24 | Very Satisfied | 17 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 40 | Very Dissatisfied | 1 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 32 | Very Satisfied | 22 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 48 | Very Satisfied | 20 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 16 | Neutral (not satisfied or dissatisfied) | 9 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 48 | Satisfied | 24 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 32 | Satisfied | 20 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 48 | Neutral (not satisfied or dissatisfied) | 11 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 24 | Satisfied | 27 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 48 | Dissatisfied | 3 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 32 | Neutral (not satisfied or dissatisfied) | 11 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 48 | Very Dissatisfied | 0 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 16 | Very Dissatisfied | 1 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 48 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 16 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 16 | Very Satisfied | 9 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 16 | Satisfied | 10 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 16 | Neutral (not satisfied or dissatisfied) | 2 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 16 | Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 24 | Very Satisfied | 7 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 24 | Satisfied | 10 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 24 | Neutral (not satisfied or dissatisfied) | 2 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 24 | Dissatisfied | 1 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 24 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 32 | Very Satisfied | 11 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 32 | Satisfied | 8 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 32 | Neutral (not satisfied or dissatisfied) | 2 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 32 | Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 32 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 40 | Very Satisfied | 10 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 40 | Satisfied | 8 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 40 | Neutral (not satisfied or dissatisfied) | 3 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 40 | Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 40 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 48 | Very Satisfied | 9 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 48 | Satisfied | 9 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 48 | Neutral (not satisfied or dissatisfied) | 3 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | Week 48 | Dissatisfied | 0 Participants |
Secondary
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.
Time frame: Week 16, 24, 32, 40 and 48
Population: ITT- observed cases
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 32 | Satisfied | 17 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 24 | Very Satisfied | 18 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 32 | Neutral (not satisfied or dissatisfied) | 14 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 16 | Neutral (not satisfied or dissatisfied) | 15 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 32 | Dissatisfied | 2 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 24 | Satisfied | 24 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 32 | Very Dissatisfied | 0 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 40 | Very Dissatisfied | 1 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 40 | Very Satisfied | 22 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 24 | Neutral (not satisfied or dissatisfied) | 13 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 40 | Satisfied | 20 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 16 | Dissatisfied | 1 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 40 | Neutral (not satisfied or dissatisfied) | 14 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 24 | Dissatisfied | 3 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 16 | Satisfied | 19 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 48 | Very Satisfied | 22 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 24 | Very Dissatisfied | 0 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 48 | Satisfied | 19 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 16 | Very Dissatisfied | 1 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 48 | Neutral (not satisfied or dissatisfied) | 15 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 32 | Very Satisfied | 24 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 48 | Dissatisfied | 2 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 40 | Dissatisfied | 2 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 48 | Very Dissatisfied | 0 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 16 | Very Satisfied | 21 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 48 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 16 | Very Satisfied | 7 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 40 | Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 16 | Satisfied | 12 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 16 | Neutral (not satisfied or dissatisfied) | 2 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 16 | Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 16 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 24 | Very Satisfied | 7 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 24 | Satisfied | 8 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 24 | Neutral (not satisfied or dissatisfied) | 5 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 24 | Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 24 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 32 | Very Satisfied | 9 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 32 | Satisfied | 7 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 32 | Neutral (not satisfied or dissatisfied) | 5 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 32 | Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 32 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 40 | Very Satisfied | 11 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 40 | Satisfied | 5 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 40 | Neutral (not satisfied or dissatisfied) | 5 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 40 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 48 | Very Satisfied | 9 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 48 | Satisfied | 8 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 48 | Neutral (not satisfied or dissatisfied) | 4 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | Week 48 | Dissatisfied | 0 Participants |
Secondary
Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself?
A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.
Time frame: Week 16, 24, 32, 40 and 48
Population: ITT- observed cases
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Investigational Study Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 48 | Satisfied | 23 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 24 | Neutral (not satisfied or dissatisfied) | 6 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 24 | Very Dissatisfied | 0 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 32 | Very Satisfied | 27 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 32 | Satisfied | 17 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 32 | Neutral (not satisfied or dissatisfied) | 12 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 24 | Satisfied | 28 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 40 | Very Satisfied | 24 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 40 | Satisfied | 21 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 40 | Neutral (not satisfied or dissatisfied) | 11 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 40 | Dissatisfied | 2 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 40 | Very Dissatisfied | 1 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 48 | Very Satisfied | 24 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 48 | Neutral (not satisfied or dissatisfied) | 9 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 48 | Dissatisfied | 2 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 48 | Very Dissatisfied | 0 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 16 | Very Satisfied | 24 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 16 | Satisfied | 19 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 16 | Neutral (not satisfied or dissatisfied) | 11 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 16 | Dissatisfied | 2 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 16 | Very Dissatisfied | 1 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 24 | Very Satisfied | 21 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 24 | Dissatisfied | 3 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 32 | Dissatisfied | 1 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 32 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 48 | Very Satisfied | 11 Participants |
| Reference Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 24 | Satisfied | 10 Participants |
| Reference Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 48 | Satisfied | 7 Participants |
| Reference Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 24 | Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 16 | Neutral (not satisfied or dissatisfied) | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 24 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 48 | Neutral (not satisfied or dissatisfied) | 3 Participants |
| Reference Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 32 | Very Satisfied | 10 Participants |
| Reference Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 24 | Very Satisfied | 10 Participants |
| Reference Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 32 | Satisfied | 8 Participants |
| Reference Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 48 | Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 32 | Neutral (not satisfied or dissatisfied) | 3 Participants |
| Reference Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 16 | Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 32 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 48 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 40 | Very Satisfied | 13 Participants |
| Reference Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 24 | Neutral (not satisfied or dissatisfied) | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 40 | Satisfied | 4 Participants |
| Reference Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 16 | Very Satisfied | 11 Participants |
| Reference Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 40 | Neutral (not satisfied or dissatisfied) | 4 Participants |
| Reference Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 16 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 40 | Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 16 | Satisfied | 10 Participants |
| Reference Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 40 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | Week 32 | Dissatisfied | 0 Participants |
Secondary
Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.
Time frame: Week 16, 24, 32, 40 and 48
Population: ITT- observed cases
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 16 | Satisfied | 23 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 32 | Dissatisfied | 2 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 48 | Satisfied | 20 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 48 | Dissatisfied | 2 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 48 | Very Dissatisfied | 0 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 16 | Very Satisfied | 16 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 16 | Neutral (not satisfied or dissatisfied) | 15 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 16 | Dissatisfied | 2 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 16 | Very Dissatisfied | 1 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 24 | Very Satisfied | 16 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 24 | Satisfied | 25 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 24 | Neutral (not satisfied or dissatisfied) | 15 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 24 | Dissatisfied | 2 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 24 | Very Dissatisfied | 0 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 32 | Very Satisfied | 21 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 32 | Satisfied | 16 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 32 | Neutral (not satisfied or dissatisfied) | 18 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 32 | Very Dissatisfied | 0 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 40 | Very Satisfied | 21 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 40 | Satisfied | 21 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 40 | Neutral (not satisfied or dissatisfied) | 14 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 40 | Dissatisfied | 2 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 40 | Very Dissatisfied | 1 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 48 | Very Satisfied | 21 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 48 | Neutral (not satisfied or dissatisfied) | 15 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 24 | Neutral (not satisfied or dissatisfied) | 6 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 32 | Neutral (not satisfied or dissatisfied) | 4 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 40 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 24 | Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 48 | Satisfied | 6 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 48 | Neutral (not satisfied or dissatisfied) | 6 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 40 | Very Satisfied | 9 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 48 | Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 24 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 48 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 40 | Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 16 | Very Satisfied | 5 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 32 | Satisfied | 9 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 16 | Satisfied | 11 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 32 | Very Satisfied | 8 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 16 | Neutral (not satisfied or dissatisfied) | 5 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 40 | Satisfied | 7 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 16 | Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 48 | Very Satisfied | 9 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 16 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 32 | Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 24 | Very Satisfied | 6 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 40 | Neutral (not satisfied or dissatisfied) | 5 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 24 | Satisfied | 8 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? | Week 32 | Very Dissatisfied | 0 Participants |
Secondary
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.
Time frame: Week 16, 24, 32, 40 and 48
Population: ITT- observed cases
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 32 | Dissatisfied | 3 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 24 | Dissatisfied | 2 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 24 | Very Satisfied | 16 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 24 | Very Dissatisfied | 0 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 48 | Very Dissatisfied | 0 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 32 | Very Satisfied | 21 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 32 | Very Dissatisfied | 0 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 40 | Very Satisfied | 22 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 16 | Satisfied | 25 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 40 | Satisfied | 21 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 16 | Neutral (not satisfied or dissatisfied) | 14 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 40 | Neutral (not satisfied or dissatisfied) | 12 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 32 | Satisfied | 19 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 40 | Dissatisfied | 3 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 16 | Dissatisfied | 1 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 40 | Very Dissatisfied | 1 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 24 | Satisfied | 30 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 48 | Very Satisfied | 19 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 16 | Very Dissatisfied | 1 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 48 | Satisfied | 21 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 32 | Neutral (not satisfied or dissatisfied) | 14 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 48 | Neutral (not satisfied or dissatisfied) | 16 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 24 | Neutral (not satisfied or dissatisfied) | 10 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 48 | Dissatisfied | 2 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 16 | Very Satisfied | 16 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 48 | Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 16 | Very Satisfied | 5 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 16 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 24 | Very Satisfied | 7 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 24 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 32 | Very Satisfied | 10 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 32 | Satisfied | 8 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 32 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 48 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 16 | Satisfied | 13 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 16 | Neutral (not satisfied or dissatisfied) | 3 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 16 | Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 24 | Satisfied | 10 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 24 | Neutral (not satisfied or dissatisfied) | 3 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 24 | Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 32 | Neutral (not satisfied or dissatisfied) | 3 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 32 | Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 40 | Very Satisfied | 11 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 40 | Satisfied | 6 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 40 | Neutral (not satisfied or dissatisfied) | 4 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 40 | Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 40 | Very Dissatisfied | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 48 | Very Satisfied | 10 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 48 | Satisfied | 4 Participants |
| Reference Product | Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | Week 48 | Neutral (not satisfied or dissatisfied) | 7 Participants |
Secondary
Subject Satisfaction With Treatment: Would You do the Treatment Again?
A subject satisfaction question with responses Yes or No.
Time frame: Week 16, 24, 32, 40 and 48
Population: ITT- observed cases
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Investigational Study Product | Subject Satisfaction With Treatment: Would You do the Treatment Again? | Week 16 | No | 4 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You do the Treatment Again? | Week 32 | Yes | 50 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You do the Treatment Again? | Week 16 | Yes | 53 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You do the Treatment Again? | Week 32 | No | 7 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You do the Treatment Again? | Week 24 | Yes | 54 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You do the Treatment Again? | Week 40 | Yes | 48 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You do the Treatment Again? | Week 48 | No | 6 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You do the Treatment Again? | Week 40 | No | 11 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You do the Treatment Again? | Week 24 | No | 4 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You do the Treatment Again? | Week 48 | Yes | 52 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You do the Treatment Again? | Week 24 | No | 3 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You do the Treatment Again? | Week 48 | No | 4 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You do the Treatment Again? | Week 16 | Yes | 19 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You do the Treatment Again? | Week 16 | No | 2 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You do the Treatment Again? | Week 24 | Yes | 17 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You do the Treatment Again? | Week 48 | Yes | 17 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You do the Treatment Again? | Week 32 | Yes | 18 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You do the Treatment Again? | Week 32 | No | 3 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You do the Treatment Again? | Week 40 | Yes | 18 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You do the Treatment Again? | Week 40 | No | 3 Participants |
Secondary
Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend?
A subject satisfaction question with responses Yes or No.
Time frame: Week 16, 24, 32, 40 and 48
Population: ITT- observed cases
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend? | Week 16 | Yes | 52 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend? | Week 16 | No | 5 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend? | Week 24 | Yes | 53 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend? | Week 24 | No | 5 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend? | Week 32 | Yes | 48 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend? | Week 32 | No | 9 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend? | Week 40 | Yes | 51 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend? | Week 40 | No | 8 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend? | Week 48 | Yes | 50 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend? | Week 48 | No | 8 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend? | Week 40 | No | 2 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend? | Week 16 | Yes | 21 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend? | Week 32 | No | 1 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend? | Week 16 | No | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend? | Week 48 | No | 2 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend? | Week 24 | Yes | 20 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend? | Week 40 | Yes | 19 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend? | Week 24 | No | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend? | Week 48 | Yes | 19 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend? | Week 32 | Yes | 20 Participants |
Secondary
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
A 5-point subject satisfaction questionnaire with the following responses: Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree, Strongly Disagree.
Time frame: Week 16, 24, 32, 40 and 48
Population: ITT- observed cases
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 16 | Strongly Agree | 37 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 32 | Disagree | 2 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 24 | Strongly Agree | 34 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 32 | Strongly Disagree | 2 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 16 | Neither agree or disagree | 2 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 40 | Strongly Agree | 31 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 24 | Agree | 16 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 40 | Agree | 16 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 32 | Neither agree or disagree | 7 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 40 | Neither agree or disagree | 8 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 24 | Neither agree or disagree | 4 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 40 | Disagree | 1 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 16 | Disagree | 2 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 40 | Strongly Disagree | 3 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 24 | Disagree | 3 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 48 | Strongly Agree | 31 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 16 | Agree | 14 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 48 | Agree | 15 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 24 | Strongly Disagree | 1 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 48 | Neither agree or disagree | 8 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 16 | Strongly Disagree | 2 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 48 | Disagree | 3 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 32 | Strongly Agree | 31 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 48 | Strongly Disagree | 1 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 32 | Agree | 15 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 48 | Strongly Disagree | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 32 | Agree | 6 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 32 | Neither agree or disagree | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 16 | Strongly Agree | 17 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 16 | Agree | 4 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 16 | Neither agree or disagree | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 16 | Disagree | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 16 | Strongly Disagree | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 24 | Strongly Agree | 14 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 24 | Agree | 6 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 24 | Neither agree or disagree | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 24 | Disagree | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 24 | Strongly Disagree | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 32 | Strongly Agree | 15 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 32 | Disagree | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 32 | Strongly Disagree | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 40 | Strongly Agree | 13 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 40 | Agree | 5 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 40 | Neither agree or disagree | 2 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 40 | Disagree | 1 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 40 | Strongly Disagree | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 48 | Strongly Agree | 15 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 48 | Agree | 4 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 48 | Neither agree or disagree | 2 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | Week 48 | Disagree | 0 Participants |
Secondary
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
A 5-point subject satisfaction questionnaire with the following responses: Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree, Strongly Disagree.
Time frame: Week 16, 24, 32, 40 and 48
Population: ITT- observed cases
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 16 | Neither agree or disagree | 2 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 32 | Disagree | 1 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 24 | Neither agree or disagree | 2 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 32 | Strong Disagree | 1 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 16 | Strong Disagree | 0 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 40 | Strongly Agree | 39 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 24 | Disagree | 0 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 40 | Agree | 15 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 16 | Agree | 16 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 40 | Neither agree or disagree | 4 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 24 | Strong Disagree | 1 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 40 | Disagree | 0 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 24 | Strongly Agree | 38 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 40 | Strong Disagree | 1 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 32 | Strongly Agree | 38 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 48 | Strongly Agree | 36 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 16 | Disagree | 1 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 48 | Agree | 18 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 32 | Agree | 16 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 48 | Neither agree or disagree | 3 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 24 | Agree | 17 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 48 | Disagree | 1 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 32 | Neither agree or disagree | 1 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 48 | Strong Disagree | 0 Participants |
| Investigational Study Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 16 | Strongly Agree | 38 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 48 | Strong Disagree | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 16 | Strongly Agree | 17 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 16 | Agree | 4 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 16 | Neither agree or disagree | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 16 | Disagree | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 16 | Strong Disagree | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 24 | Strongly Agree | 15 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 24 | Agree | 5 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 24 | Neither agree or disagree | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 24 | Disagree | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 24 | Strong Disagree | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 32 | Strongly Agree | 15 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 32 | Agree | 6 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 32 | Neither agree or disagree | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 32 | Disagree | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 32 | Strong Disagree | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 40 | Strongly Agree | 14 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 40 | Agree | 7 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 40 | Neither agree or disagree | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 40 | Disagree | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 40 | Strong Disagree | 0 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 48 | Strongly Agree | 15 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 48 | Agree | 5 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 48 | Neither agree or disagree | 1 Participants |
| Reference Product | Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | Week 48 | Disagree | 0 Participants |