治験レーダー

Change in Cheek Volume, as quantified by Quantificare's LifeViz Software

The investigators will look at changes in cheek volume (in mL). The investigators will utilize the Quantificare LifeViz Infinity 3D imaging system at each visit to capture high-resolution, three-dimensional photographs of the participant's face from multiple angles, reconstructing a precise 3D model of the participant's facial surface. Using the system's software, volumetric and depth differences can be computed between time points by superimposing the 3D scans. The device's markerless tracking technology provides quantitative assessment of soft tissue changes, measuring the degree of tissue lifting or volume loss between visits.

Up to 6 months

Change in Jowl Volume, as quantified by Quantificare's LifeViz Software

The investigators will look at changes in jowl volume (in mL). The investigators will utilize the Quantificare LifeViz Infinity 3D imaging system at each visit to capture high-resolution, three-dimensional photographs of the participant's face from multiple angles, reconstructing a precise 3D model of the participant's facial surface. Using the system's software, volumetric and depth differences can be computed between time points by superimposing the 3D scans. The device's markerless tracking technology provides quantitative assessment of soft tissue changes, measuring the degree of tissue lifting or volume loss between visits.

Up to 6 months

Change in Nasolabial Fold Depth, as quantified by Quantificare's LifeViz Software

The investigators will look at changes in nasolabial fold depth (in mm). The investigators will utilize the Quantificare LifeViz Infinity 3D imaging system at each visit to capture high-resolution, three-dimensional photographs of the participant's face from multiple angles, reconstructing a precise 3D model of the participant's facial surface. Using the system's software, volumetric and depth differences can be computed between time points by superimposing the 3D scans. The device's markerless tracking technology provides quantitative assessment of soft tissue changes, measuring the degree of tissue lifting between visits.

Up to 6 months

Change in Marionette Line Depth, as quantified by Quantificare's LifeViz Software

The investigators will look at changes in marionette line depth (in mm). The investigators will utilize the Quantificare LifeViz Infinity 3D imaging system at each visit to capture high-resolution, three-dimensional photographs of the participant's face from multiple angles, reconstructing a precise 3D model of the participant's facial surface. Using the system's software, volumetric and depth differences can be computed between time points by superimposing the 3D scans. The device's markerless tracking technology provides quantitative assessment of soft tissue changes, measuring the degree of tissue lifting between visits.

Up to 6 months

Body Mass Index (BMI)

The participant's weight (kilograms) and height (meters) will be collected to calculate individual BMI at each live assessment. Investigators will explore correlations between changes in BMI and facial volume loss over the period of the study.

Up to 12 months

Global Aesthetic Improvement Scale (GAIS) for Global Facial Aesthetic Appearance

Based on aesthetic appearance, qualitative success of treatment will be evaluated by the treating physician and blinded evaluators using the GAIS. Aesthetic appearance will be rated one of the five following options: * Worse: The appearance is worse than the original condition * No Change: The appearance is essentially the same as the original condition * Improved: Obvious improvement in appearance from initial condition, but a re-treatment is indicated * Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject * Very Much Improved: Optimal cosmetic result in this subject

Up to 6 months

Global Aesthetic Improvement Scale (GAIS) for Skin Quality

Qualitative success of treatment will be evaluated by the treating physician and blinded evaluators using the GAIS. Changes in skin quality will be rated one of the five following options: * Worse: The appearance is worse than the original condition * No Change: The appearance is essentially the same as the original condition * Improved: Obvious improvement in appearance from initial condition, but a re-treatment is indicated * Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject * Very Much Improved: Optimal cosmetic result in this subject

Up to 6 months

Global Aesthetic Improvement Scale (GAIS) for Skin Radiance

Qualitative success of treatment will be evaluated by the treating physician and blinded evaluators using the GAIS. Changes in skin radiance will be rated one of the five following options: * Worse: The appearance is worse than the original condition * No Change: The appearance is essentially the same as the original condition * Improved: Obvious improvement in appearance from initial condition, but a re-treatment is indicated * Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject * Very Much Improved: Optimal cosmetic result in this subject

Up to 6 months

Change in Cheek Volume, as quantified by Quantificare's LifeViz Software

The investigators will look at changes in cheek volume (in mL). The investigators will utilize the Quantificare LifeViz Infinity 3D imaging system at each visit to capture high-resolution, three-dimensional photographs of the participant's face from multiple angles, reconstructing a precise 3D model of the participant's facial surface. Using the system's software, volumetric and depth differences can be computed between time points by superimposing the 3D scans. The device's markerless tracking technology provides quantitative assessment of soft tissue changes, measuring the degree of tissue lifting or volume loss between visits.

Up to 12 months

Changes in Jowl Volume, as quantified by Quantificare's LifeViz Software

The investigators will look at changes in jowl volume (in mL). The investigators will utilize the Quantificare LifeViz Infinity 3D imaging system at each visit to capture high-resolution, three-dimensional photographs of the participant's face from multiple angles, reconstructing a precise 3D model of the participant's facial surface. Using the system's software, volumetric and depth differences can be computed between time points by superimposing the 3D scans. The device's markerless tracking technology provides quantitative assessment of soft tissue changes, measuring the degree of tissue lifting or volume loss between visits.

Up to 12 months

Change in Nasolabial Fold Depth, as quantified by Quantificare's LifeViz Software

The investigators will look at changes in nasolabial fold depth (in mm). The investigators will utilize the Quantificare LifeViz Infinity 3D imaging system at each visit to capture high-resolution, three-dimensional photographs of the participant's face from multiple angles, reconstructing a precise 3D model of the participant's facial surface. Using the system's software, volumetric and depth differences can be computed between time points by superimposing the 3D scans. The device's markerless tracking technology provides quantitative assessment of soft tissue changes, measuring the degree of tissue lifting between visits.

Up to 12 months

Change in Marionette Line Depth, as quantified by Quantificare's LifeViz Software

The investigators will look at changes in marionette line depth (in mm). The investigators will utilize the Quantificare LifeViz Infinity 3D imaging system at each visit to capture high-resolution, three-dimensional photographs of the participant's face from multiple angles, reconstructing a precise 3D model of the participant's facial surface. Using the system's software, volumetric and depth differences can be computed between time points by superimposing the 3D scans. The device's markerless tracking technology provides quantitative assessment of soft tissue changes, measuring the degree of tissue lifting between visits.

Up to 12 months

Merz Cheek Fullness Assessment Scale

The treating physician and blinded evaluators will rate the participant at each live assessment. The scale classifies cheek fullness into 5 categories: (0) Full Cheek: Full cheek region, tear trough may be present 1. Mildly Sunken Cheek: Mildly flattened cheek region, tear trough may be present 2. Moderately Sunken Cheek: Moderately sunken cheek, tear trough may be present 3. Severely Sunken Cheek: Severely sunken cheek with marked cheek volume loss, tear trough present 4. Very Severely Sunken Cheek: Very severely sunken cheek with extensive cheek volume loss, distinct tear trough

Up to 12 months

Merz Jawline Assessment Scale

The treating physician and blinded evaluators will rate the participant at each live assessment. The scale classifies jawline contour deficiencies into 5 categories: (0) None: Continuous jawline contour, no loss of jawline volume 1. Mild: Mild loss of jawline contour and continuity, mild loss of volume in the post-jowl region, loss of volume in the pre-jowl region may be present 2. Moderate: Moderate loss of jawline contour and continuity, moderate loss of volume in the post-jowl region, loss of volume in the pre-jowl region may be present 3. Severe: Severe loss of jawline contour and continuity, severe loss of volume in the post-jowl region, loss of volume in the pre-jowl region may be present 4. Extreme: Extreme disruption of jawline contour; extreme post-jowl and pre-jowl volume loss

Up to 12 months

Merz Aesthetics Nasolabial Fold (At Rest) Scale for Clinical Evaluation

The treating physician and blinded evaluators will rate the participant at each live assessment. The scale classifies nasolabial folds at rest into 5 categories: (0) No folds 1. Mild folds 2. Moderate folds 3. Severe folds 4. Very Severe folds

Up to 12 months

Merz Aesthetics Marionette Lines (At Rest) Scale for Clinical Evaluation

The treating physician and blinded evaluators will rate the participant at each live assessment. The scale classifies marionette lines at rest into 5 categories: (0) No lines 1. Mild lines 2. Moderate lines 3. Severe lines 4. Very Severe lines

Up to 12 months

Merz Aesthetics Oral Commissures (At Rest) Scale for Clinical Evaluation

The treating physician and blinded evaluators will rate the participant at each live assessment. The scale classifies oral commissures at rest into 5 categories: (0) No downturn 1. Mild downturn 2. Moderate downturn 3. Severe downturn 4. Very Severe downturn

Up to 12 months

Merz Aesthetics Lower Cheek Fullness (At Rest) Scale for Clinical Evaluation

The treating physician and blinded evaluators will rate the participant at each live assessment. The scale classifies lower cheek fullness at rest into 5 categories: (0) Full lower cheek 1. Mildly sunken lower cheek 2. Moderately sunken lower cheek 3. Severely sunken lower cheek 4. Very severely sunken lower cheek

Up to 12 months

Merz Aesthetics Upper Cheek Fullness (At Rest) Scale for Clinical Evaluation

The treating physician and blinded evaluators will rate the participant at each live assessment. The scale classifies upper cheek fullness at rest into 5 categories: (0) Full upper cheek 1. Mildly sunken upper cheek 2. Moderately sunken upper cheek 3. Severely sunken upper cheek 4. Very severely sunken upper cheek

Up to 12 months

Global Aesthetic Improvement Scale (GAIS) for Global Facial Aesthetic Appearance

Based on aesthetic appearance, qualitative success of treatment will be evaluated by the treating physician and blinded evaluators using the GAIS. Aesthetic appearance will be rated one of the five following options: * Worse: The appearance is worse than the original condition * No Change: The appearance is essentially the same as the original condition * Improved: Obvious improvement in appearance from initial condition, but a re-treatment is indicated * Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject * Very Much Improved: Optimal cosmetic result in this subject

Up to 12 months

Global Aesthetic Improvement Scale (GAIS) for Skin Quality

Qualitative success of treatment will be evaluated by the treating physician and blinded evaluators using the GAIS. Changes in skin quality will be rated one of the five following options: * Worse: The appearance is worse than the original condition * No Change: The appearance is essentially the same as the original condition * Improved: Obvious improvement in appearance from initial condition, but a re-treatment is indicated * Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject * Very Much Improved: Optimal cosmetic result in this subject

Up to 12 months

Global Aesthetic Improvement Scale (GAIS) for Skin Radiance

Qualitative success of treatment will be evaluated by the treating physician and blinded evaluators using the GAIS. Changes in skin radiance will be rated one of the five following options: * Worse: The appearance is worse than the original condition * No Change: The appearance is essentially the same as the original condition * Improved: Obvious improvement in appearance from initial condition, but a re-treatment is indicated * Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject * Very Much Improved: Optimal cosmetic result in this subject

Up to 12 months

Psychosocial Questionnaires

For Group A, patient-reported questionnaires assess anticipated concern prior to treatment and perceived maintenance of facial appearance, psychosocial confidence, and satisfaction with the decision to treat early during the course of medication-associated weight loss. Questionnaires focus on preservation of facial appearance, confidence during weight loss, and perceived value of early intervention. For Group B, patient-reported questionnaires assess the psychosocial impact of facial volume loss and appearance-related changes occurring during weight loss prior to treatment, followed by satisfaction, perceived improvement, and psychosocial benefit after facial volume restoration. Participants will be given a list of statements about face and appearance. Participants will be asked to indicate level of agreement or disagreement with each statement using the following scale: (1) strongly disagree, (2) disagree, (3) neutral, (4) agree, or (5) strongly agree.

Up to 12 months

Patient Treatment Satisfaction

Participants will rate their satisfaction with the treatment at each treatment visit and at each subsequent live assessment. Patient satisfaction will be assessed using a 5-point scale: (1) extremely dissatisfied, (2) dissatisfied, (3) slightly satisfied, (4) satisfied, and (5) extremely satisfied.

Up to 12 months