Facial Rhytides, Crow's Feet Lines, Glabellar Lines, Nasolabial Fold
Conditions
Brief summary
A study to evaluate patient satisfaction, aesthetic and psychological impact of combined treatment with BOTOX® Cosmetic (onabotulinumtoxinA), JUVÉDERM® ULTRA XC, JUVÉDERM® ULTRA PLUS XC, JUVÉDERM® VOLUMA® XC, and LATISSE® (bimatoprost ophthalmic solution).
Interventions
BIOLOGICALonabotulinumtoxinA
onabotulinumtoxinA (BOTOX® Cosmetic) 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas.
bimatoprost ophthalmic solution 0.03% (LATISSE®) 1 drop applied to the upper eyelid at the base of eyelashes once daily in the evening for 17 weeks.
DEVICEJUVÉDERM® ULTRA XC
JUVÉDERM® ULTRA XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator.
DEVICEJUVÉDERM® ULTRA PLUS XC
JUVÉDERM® ULTRA PLUS XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator.
DEVICEJUVÉDERM® VOLUMA® XC
JUVÉDERM® VOLUMA® XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator.
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Qualified to receive treatment with BOTOX® Cosmetic, a facial filler (JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA Plus XC and/or JUVÉDERM® VOLUMA® XC) and LATISSE® treatment * Naïve to botulinum toxin therapy of any serotype for any indication * Naïve to prescription eyelash growth products of any type * Naïve to dermal filler treatment in the face and neck
Exclusion criteria
* Undergone facial plastic surgery, tissue grafting, tissue augmentation or facial dermal filler injections * Had laser, photomodulation, intense pulsed light, radio frequency, dermabrasion or chemical peel in the face or neck * Have received skin resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel, or non-ablative procedures) in the face or neck within 3 months * Systemic retinoid therapy within 1 year prior to study enrollment * Presence of inflammation at the proposed injection site(s) * Profound atrophy/excessive weakness of muscles in target areas of injection * Known immunization or hypersensitivity to any botulinum toxin serotype * Undergone oral surgery or dental procedures within 30 days * No visible eyelashes * Use of permanent eyeliner, eyelash implants, semi-permanent eyelash tint, dye or extension * Use of prescription eyelash growth products * Unwilling or unable to remove contact lenses prior to study medication application in the evening and keep lenses out for 30 minutes * Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, amyotrophic lateral sclerosis, or any other disease that might interfere with neuromuscular function.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Satisfaction With Facial Appearance Overall Using a 10-item Questionnaire | Baseline, Month 4 | Participants assessed their satisfaction with the way they look right now with their entire face in mind using a 10-item questionnaire. Possible responses to each question were: 1=Very dissatisfied, 2=Somewhat dissatisfied, 3-=Somewhat satisfied and 4=Very satisfied. The responses were added across items and transformed to a Rasch scale ranging from 0 (worst) to 100 (best). A positive change from Baseline indicates improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Age Appraisal Using a Visual Analogue Scale (VAS) | Baseline, Month 4 | Participants assessed how old they think they look compared to their actual age using a VAS by placing a mark on a number on a horizontal line where the far left of the line= -15 (look 15 years younger), 0=look current age, to the far right of the line=15 (look 15 years older). A positive change from Baseline indicates improvement. |
| Change From Baseline in Social Confidence Using an 8-item Questionnaire | Baseline, Month 4 | Participants assessed their social confidence with their facial appearance in mind in the past week using an 8-item questionnaire. Possible responses for each question are 1=Definitely disagree, 2=Somewhat disagree, 3=Somewhat agree or 4= Definitely agree. The responses were added across items and transformed to a Rasch score ranging from 0 (worst) to 100 (best). A positive change from Baseline indicates improvement. |
| Change From Baseline in Psychological Well-Being Using a 10-item Questionnaire | Baseline, Month 4 | Participants assessed their psychological well-being with their facial appearance in mind using a 10-item questionnaire. Possible responses for each question are 1=Definitely disagree, 2=Somewhat disagree, 3=Somewhat agree or 4= Definitely agree. The responses were added across items and transformed to a Rasch score ranging from 0 (worst) to 100 (best). A positive change from Baseline indicates improvement. |
| Participant's Self- Perception of Age (SPA) | Baseline, Month 4 | Participants assessed SPA by answering the question: How do you think your facial appearance looks compared to your age today? Participants recorded how many years younger or older they thought their facial appearance made them look. A negative result indicates improvement (a younger appearance). |
| Change From Baseline in Investigator's Assessment of Severity of Glabellar Lines (GLs) at Maximum Frown Using the Facial Wrinkle Scale (FWS) | Baseline, Month 4 | The investigator assessed the severity of the participant's GLs using the 4-point FWS where: 0=None, 1=Mild, 2=Moderate or 3=Severe. A negative change from Baseline indicates improvement. |
| Change From Baseline in Investigator's Assessment of the Severity of Crow's Feet Lines (CFLs) at Maximum Smile Using the FWS | Baseline, Month 4 | The investigator assessed the severity of the participant's CFLs using the 4-point FWS where: 0=None, 1=Mild, 2=Moderate or 3=Severe. A negative change from Baseline indicates improvement. |
| Change From Baseline in Aging Appearance Using a 7-item Questionnaire | Baseline, Month 4 | Participants rated how they look now using a 7-item questionnaire. Possible responses for each question are 1=Definitely disagree, 2=Somewhat disagree, 3=Somewhat agree or 4=Definitely agree. The responses were added across items and transformed to a Rasch score ranging from 0 (worst) to 100 (best). A positive change from Baseline indicates improvement. |
| Change From Baseline in the Investigator's Assessment of the Participant's Overall Mid-Face Volume Deficit Using the 6-Point MFVDS | Baseline, Month 4 | The investigator assessed overall mid-face volume deficit using the Mid-face Volume Deficit Scale (MFVDS) where: 0=None (moon face; fullness) \[best\], 1=Minimal (flattening), 2=Mild (mild concavity), 3=Moderate (moderate concavity, 4=Significant (significant concavity) and 5=Severe (wasting) \[worst\]. A negative change from Baseline indicates improvement. |
| Change From Baseline in the Investigator's Assessment of the Participant's Nasolabial Folds Severity | Baseline, Month 4 | The investigator assessed the participants nasolabial folds severity using the 5-Point Nasolabial Fold Severity (NLFS) Scale where: 0=None (no wrinkles) \[best\], 1=Mild (shallow, just perceptible wrinkle), 2=Moderate (moderately deep wrinkle), 3=Severe (deep wrinkle) or 4= Extreme (very deep wrinkle). A negative change from Baseline indicates improvement. |
| Change From Baseline in the Investigator's Assessment of the Participant's Oral Commissures Severity | Baseline, Month 4 | The investigator assessed the participant's oral commissure using the 4-Point Oral Commissure Severity Scale (OCSS) where: 0=None, 1=Mild, 2=Moderate or 3=Severe. A negative change from Baseline indicates improvement. |
| Change From Baseline in the Investigator's Assessment of the Participant's Perioral Lines Severity | Baseline, Month 4 | The investigator assessed the participant's perioral lines severity using the 4-Point Perioral Lines at Rest Severity Scale (POLSS) where: 0=None (no lines) \[best\], 1=Mild (few, shallow lines), 2=Moderate (some moderate lines) or 3=Severe (many deep lines or crevices)\[worst\]. A negative change from Baseline indicates improvement. |
| Change From Baseline in the Participant Satisfaction With Appearance of Periorbital Area | Baseline, Month 4 | Participants assessed how their overall eye appearance has affected them over the past 7 days using the 9-item Periorbital Aesthetic Appearance Questionnaire (PAAQ). Possible responses to each question were: 0=Never (best), 1=Rarely, 2=Some of the time, 3=Most of the time and 4=All of the time with a total possible score of 0 to 36. A negative change from Baseline indicates improvement. |
| Change From Baseline in Investigator's Global Eyelash Assessment Score (GEAS) | Baseline, Month 4 | The investigator assessed the participant's eyelash prominence using the 4-point GEAS where: 1=Minimal (worst), 2=Moderate, 3=Marked and 4=Very Marked (best). A positive change from Baseline indicates improvement. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3. | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Other Miscellaneous Reasons | 2 |
| Overall Study | Personal Reasons | 3 |
| Overall Study | Screen Failure | 14 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 52.5 years STANDARD_DEVIATION 7.4 |
| Sex: Female, Male Female | 96 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 18 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
Primary
Change From Baseline in Satisfaction With Facial Appearance Overall Using a 10-item Questionnaire
Participants assessed their satisfaction with the way they look right now with their entire face in mind using a 10-item questionnaire. Possible responses to each question were: 1=Very dissatisfied, 2=Somewhat dissatisfied, 3-=Somewhat satisfied and 4=Very satisfied. The responses were added across items and transformed to a Rasch scale ranging from 0 (worst) to 100 (best). A positive change from Baseline indicates improvement.
Time frame: Baseline, Month 4
Population: Modified Intent-to-Treat (mITT) population included all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Change From Baseline in Satisfaction With Facial Appearance Overall Using a 10-item Questionnaire | Baseline | 41.22 score on a scale | Standard Deviation 11.97 |
| All Participants | Change From Baseline in Satisfaction With Facial Appearance Overall Using a 10-item Questionnaire | Change from Baseline at Month 4 | 31.70 score on a scale | Standard Deviation 20 |
Secondary
Change From Baseline in Age Appraisal Using a Visual Analogue Scale (VAS)
Participants assessed how old they think they look compared to their actual age using a VAS by placing a mark on a number on a horizontal line where the far left of the line= -15 (look 15 years younger), 0=look current age, to the far right of the line=15 (look 15 years older). A positive change from Baseline indicates improvement.
Time frame: Baseline, Month 4
Population: Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Change From Baseline in Age Appraisal Using a Visual Analogue Scale (VAS) | Baseline | 0.1 years | Standard Deviation 4.28 |
| All Participants | Change From Baseline in Age Appraisal Using a Visual Analogue Scale (VAS) | Change from Baseline at Month 4 (n=92) | -4.6 years | Standard Deviation 4.36 |
Secondary
Change From Baseline in Aging Appearance Using a 7-item Questionnaire
Participants rated how they look now using a 7-item questionnaire. Possible responses for each question are 1=Definitely disagree, 2=Somewhat disagree, 3=Somewhat agree or 4=Definitely agree. The responses were added across items and transformed to a Rasch score ranging from 0 (worst) to 100 (best). A positive change from Baseline indicates improvement.
Time frame: Baseline, Month 4
Population: mITT population included all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Change From Baseline in Aging Appearance Using a 7-item Questionnaire | Baseline | 45.07 score on a scale | Standard Deviation 18.85 |
| All Participants | Change From Baseline in Aging Appearance Using a 7-item Questionnaire | Change from Baseline at Month 4 | 28.47 score on a scale | Standard Deviation 21.47 |
Secondary
Change From Baseline in Investigator's Assessment of Severity of Glabellar Lines (GLs) at Maximum Frown Using the Facial Wrinkle Scale (FWS)
The investigator assessed the severity of the participant's GLs using the 4-point FWS where: 0=None, 1=Mild, 2=Moderate or 3=Severe. A negative change from Baseline indicates improvement.
Time frame: Baseline, Month 4
Population: Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Change From Baseline in Investigator's Assessment of Severity of Glabellar Lines (GLs) at Maximum Frown Using the Facial Wrinkle Scale (FWS) | Baseline | 2.6 score on a scale | Standard Deviation 0.5 |
| All Participants | Change From Baseline in Investigator's Assessment of Severity of Glabellar Lines (GLs) at Maximum Frown Using the Facial Wrinkle Scale (FWS) | Change from Baseline at Month 4 | -1.6 score on a scale | Standard Deviation 0.78 |
Secondary
Change From Baseline in Investigator's Assessment of the Severity of Crow's Feet Lines (CFLs) at Maximum Smile Using the FWS
The investigator assessed the severity of the participant's CFLs using the 4-point FWS where: 0=None, 1=Mild, 2=Moderate or 3=Severe. A negative change from Baseline indicates improvement.
Time frame: Baseline, Month 4
Population: Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Change From Baseline in Investigator's Assessment of the Severity of Crow's Feet Lines (CFLs) at Maximum Smile Using the FWS | Right_Baseline | 2.5 score on a scale | Standard Deviation 0.5 |
| All Participants | Change From Baseline in Investigator's Assessment of the Severity of Crow's Feet Lines (CFLs) at Maximum Smile Using the FWS | Right_Change from Baseline at Month 4 | -1.0 score on a scale | Standard Deviation 0.85 |
| All Participants | Change From Baseline in Investigator's Assessment of the Severity of Crow's Feet Lines (CFLs) at Maximum Smile Using the FWS | Left_Baseline | 2.5 score on a scale | Standard Deviation 0.5 |
| All Participants | Change From Baseline in Investigator's Assessment of the Severity of Crow's Feet Lines (CFLs) at Maximum Smile Using the FWS | Left_Change from Baseline at Month 4 | -1.0 score on a scale | Standard Deviation 0.85 |
Secondary
Change From Baseline in Investigator's Global Eyelash Assessment Score (GEAS)
The investigator assessed the participant's eyelash prominence using the 4-point GEAS where: 1=Minimal (worst), 2=Moderate, 3=Marked and 4=Very Marked (best). A positive change from Baseline indicates improvement.
Time frame: Baseline, Month 4
Population: Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Change From Baseline in Investigator's Global Eyelash Assessment Score (GEAS) | Baseline | 1.8 score on a scale | Standard Deviation 0.42 |
| All Participants | Change From Baseline in Investigator's Global Eyelash Assessment Score (GEAS) | Change from Baseline at Month 4 | 1.5 score on a scale | Standard Deviation 0.65 |
Secondary
Change From Baseline in Psychological Well-Being Using a 10-item Questionnaire
Participants assessed their psychological well-being with their facial appearance in mind using a 10-item questionnaire. Possible responses for each question are 1=Definitely disagree, 2=Somewhat disagree, 3=Somewhat agree or 4= Definitely agree. The responses were added across items and transformed to a Rasch score ranging from 0 (worst) to 100 (best). A positive change from Baseline indicates improvement.
Time frame: Baseline, Month 4
Population: mITT population included all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Change From Baseline in Psychological Well-Being Using a 10-item Questionnaire | Baseline | 62.78 score on a scale | Standard Deviation 22.45 |
| All Participants | Change From Baseline in Psychological Well-Being Using a 10-item Questionnaire | Change from Baseline at Month 4 | 19.89 score on a scale | Standard Deviation 20.63 |
Secondary
Change From Baseline in Social Confidence Using an 8-item Questionnaire
Participants assessed their social confidence with their facial appearance in mind in the past week using an 8-item questionnaire. Possible responses for each question are 1=Definitely disagree, 2=Somewhat disagree, 3=Somewhat agree or 4= Definitely agree. The responses were added across items and transformed to a Rasch score ranging from 0 (worst) to 100 (best). A positive change from Baseline indicates improvement.
Time frame: Baseline, Month 4
Population: mITT population included all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Change From Baseline in Social Confidence Using an 8-item Questionnaire | Baseline | 62.70 score on a scale | Standard Deviation 21.74 |
| All Participants | Change From Baseline in Social Confidence Using an 8-item Questionnaire | Change from Baseline at Month 4 | 18.24 score on a scale | Standard Deviation 23.04 |
Secondary
Change From Baseline in the Investigator's Assessment of the Participant's Nasolabial Folds Severity
The investigator assessed the participants nasolabial folds severity using the 5-Point Nasolabial Fold Severity (NLFS) Scale where: 0=None (no wrinkles) \[best\], 1=Mild (shallow, just perceptible wrinkle), 2=Moderate (moderately deep wrinkle), 3=Severe (deep wrinkle) or 4= Extreme (very deep wrinkle). A negative change from Baseline indicates improvement.
Time frame: Baseline, Month 4
Population: Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Change From Baseline in the Investigator's Assessment of the Participant's Nasolabial Folds Severity | Baseline | 2.6 score on a scale | Standard Deviation 0.51 |
| All Participants | Change From Baseline in the Investigator's Assessment of the Participant's Nasolabial Folds Severity | Change from Baseline at Month 4 | -1.0 score on a scale | Standard Deviation 0.85 |
Secondary
Change From Baseline in the Investigator's Assessment of the Participant's Oral Commissures Severity
The investigator assessed the participant's oral commissure using the 4-Point Oral Commissure Severity Scale (OCSS) where: 0=None, 1=Mild, 2=Moderate or 3=Severe. A negative change from Baseline indicates improvement.
Time frame: Baseline, Month 4
Population: Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Change From Baseline in the Investigator's Assessment of the Participant's Oral Commissures Severity | Baseline | 2.1 score on a scale | Standard Deviation 0.49 |
| All Participants | Change From Baseline in the Investigator's Assessment of the Participant's Oral Commissures Severity | Change from Baseline at Month 4 | -0.9 score on a scale | Standard Deviation 0.67 |
Secondary
Change From Baseline in the Investigator's Assessment of the Participant's Overall Mid-Face Volume Deficit Using the 6-Point MFVDS
The investigator assessed overall mid-face volume deficit using the Mid-face Volume Deficit Scale (MFVDS) where: 0=None (moon face; fullness) \[best\], 1=Minimal (flattening), 2=Mild (mild concavity), 3=Moderate (moderate concavity, 4=Significant (significant concavity) and 5=Severe (wasting) \[worst\]. A negative change from Baseline indicates improvement.
Time frame: Baseline, Month 4
Population: Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Change From Baseline in the Investigator's Assessment of the Participant's Overall Mid-Face Volume Deficit Using the 6-Point MFVDS | Baseline | 3.1 score on a scale | Standard Deviation 0.36 |
| All Participants | Change From Baseline in the Investigator's Assessment of the Participant's Overall Mid-Face Volume Deficit Using the 6-Point MFVDS | Change from Baseline at Month 4 | -1.7 score on a scale | Standard Deviation 0.8 |
Secondary
Change From Baseline in the Investigator's Assessment of the Participant's Perioral Lines Severity
The investigator assessed the participant's perioral lines severity using the 4-Point Perioral Lines at Rest Severity Scale (POLSS) where: 0=None (no lines) \[best\], 1=Mild (few, shallow lines), 2=Moderate (some moderate lines) or 3=Severe (many deep lines or crevices)\[worst\]. A negative change from Baseline indicates improvement.
Time frame: Baseline, Month 4
Population: Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Change From Baseline in the Investigator's Assessment of the Participant's Perioral Lines Severity | Baseline | 2.0 score on a scale | Standard Deviation 0.57 |
| All Participants | Change From Baseline in the Investigator's Assessment of the Participant's Perioral Lines Severity | Change from Baseline at Month 4 | -1.1 score on a scale | Standard Deviation 0.68 |
Secondary
Change From Baseline in the Participant Satisfaction With Appearance of Periorbital Area
Participants assessed how their overall eye appearance has affected them over the past 7 days using the 9-item Periorbital Aesthetic Appearance Questionnaire (PAAQ). Possible responses to each question were: 0=Never (best), 1=Rarely, 2=Some of the time, 3=Most of the time and 4=All of the time with a total possible score of 0 to 36. A negative change from Baseline indicates improvement.
Time frame: Baseline, Month 4
Population: Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Change From Baseline in the Participant Satisfaction With Appearance of Periorbital Area | Baseline | 21.1 score on a scale | Standard Deviation 6.71 |
| All Participants | Change From Baseline in the Participant Satisfaction With Appearance of Periorbital Area | Change from Baseline at Month 4 | -12.6 score on a scale | Standard Deviation 7.61 |
Secondary
Participant's Self- Perception of Age (SPA)
Participants assessed SPA by answering the question: How do you think your facial appearance looks compared to your age today? Participants recorded how many years younger or older they thought their facial appearance made them look. A negative result indicates improvement (a younger appearance).
Time frame: Baseline, Month 4
Population: mITT population included all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Participant's Self- Perception of Age (SPA) | Baseline | 0.2 years | Standard Deviation 4.08 |
| All Participants | Participant's Self- Perception of Age (SPA) | Month 4 | -4.6 years | Standard Deviation 4.19 |