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| Name | Class |
|---|---|
| Merz Aesthetics Inc. | INDUSTRY |
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The purpose of this study is to determine if Radiesse injections to the cheeks result in an altered and improved first impression and self esteem.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcium hydroxylapatite | Experimental | Subject will be treated at baseline and, if needed, at 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium hydroxylapatite | Drug | Subjects will be treated to full correction at visit 1 and, if needed, a touch-up injection at 2 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blinded Evaluations of First Impression | Upon completion of the study, 300 blinded evaluators will evaluate one of three binders comprised of a random visit photographs from baseline, optimal cosmetic result, and 1 month post optimal cosmetic result of 20 subjects. The 10-point (1=Not at all to 10=Extremely well) First Impression Scales consisting of 8 criteria. A score of 10 means favorable results and a score of 1 means unfavorable results. | After the 1-month post optimal correction visit for 20 subjects (averaged) |
| Self-esteem | Self-esteem change will be determined by patient self-evaluation using the Heatherton & Polivy State Self-Esteem (HPSS). The primary variable will be measured as improvement in self-esteem from baseline self-evaluations. A 20-item scale that measures a participant's self-esteem at a given point in time. The 20 items are subdivided into 3 components of self-esteem: (1) performance self-esteem, social self-esteem, and appearance self-esteem. All items are answered using a 5-point scale (1= not at all, 2= a little bit, 3= somewhat, 4= very much, 5= extremely). Scores range from 20-100. Scores closer to 100 indicate a more favorable outcome. | 1 month |
| Self-esteem | Self-esteem change will be determined by patient self-evaluation using the Heatherton & Polivy State Self-Esteem (HPSS). The primary variable will be measured as improvement in self-esteem from baseline self-evaluations. Self-esteem change will be determined by patient self-evaluation using the Heatherton & Polivy State Self-Esteem (HPSS). The primary variable will be measured as improvement in self-esteem from baseline self-evaluations. A 20-item scale that measures a participant's self-esteem at a given point in time. The 20 items are subdivided into 3 components of self-esteem: (1) performance self-esteem, social self-esteem, and appearance self-esteem. All items are answered using a 5-point scale (1= not at all, 2= a little bit, 3= somewhat, 4= very much, 5= extremely). Scores range from 20-100. Scores closer to 100 indicate a more favorable outcome. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Subject First Impression | Each subject will complete a 10-point (1-Not at all to 10-Very Much) scale evaluating their own first impression at Baseline and 1-month post-OCR. First impression scores were recorded at baseline and 1-month post-OCR, and an average of the two scores were reported. | baseline and 1 month post-OCR (averaged) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven H Dayan, MD | DeNova Research/ Chicago Center for Facial Plastic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DeNova Research | Chicago | Illinois | 60611 | United States |
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| Label | URL |
|---|---|
| DeNova Research | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Calcium Hydroxylapatite | Subject will be treated at baseline and, if needed, at 2 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Calcium Hydroxylapatite | Subject will be treated at baseline and, if needed, at 2 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blinded Evaluations of First Impression | Upon completion of the study, 300 blinded evaluators will evaluate one of three binders comprised of a random visit photographs from baseline, optimal cosmetic result, and 1 month post optimal cosmetic result of 20 subjects. The 10-point (1=Not at all to 10=Extremely well) First Impression Scales consisting of 8 criteria. A score of 10 means favorable results and a score of 1 means unfavorable results. | Posted | Mean | Full Range | score on a scale | After the 1-month post optimal correction visit for 20 subjects (averaged) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Calcium Hydroxylapatite | Subject will be treated at baseline and, if needed, at 2 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jack Arkins, Data Manager | DeNova Research | 312-335-2070 | jack@drdayan.com |
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| ID | Term |
|---|---|
| D017886 | Durapatite |
| C000618322 | Prolaryn Plus |
| ID | Term |
|---|---|
| D006882 | Hydroxyapatites |
| D001031 | Apatites |
| D002130 | Calcium Phosphates |
| D010710 | Phosphates |
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| Assessment of Malar Deficiency |
Live subject malar deficiency severity will be rated by PI at Visits 1-4 according to the SOBER scale (Weeks 1-4 correspond to Visits 1-4). SOBER Scale (Solish Beer Remington Scale): is used to grade facial rhytids in the malar region. Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Extreme Grade 5: Extreme Scores closer to 1 is a more favorable outcome, while scores closer to 5 is a less favorable outcome |
| 1 month |
| Aesthetic Improvement | Investigator will complete GAIS (Global Aesthetic Improvement Scale) at Visits 2-4 comparing overall appearance of current visit's photo to baseline photo. Worse: -1 No Change: 0 Improved: 1 Much Improved: 2 Very Much Improved: 3 | 1 month |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Self-esteem | Self-esteem change will be determined by patient self-evaluation using the Heatherton & Polivy State Self-Esteem (HPSS). The primary variable will be measured as improvement in self-esteem from baseline self-evaluations. A 20-item scale that measures a participant's self-esteem at a given point in time. The 20 items are subdivided into 3 components of self-esteem: (1) performance self-esteem, social self-esteem, and appearance self-esteem. All items are answered using a 5-point scale (1= not at all, 2= a little bit, 3= somewhat, 4= very much, 5= extremely). Scores range from 20-100. Scores closer to 100 indicate a more favorable outcome. | All subjects completing indicated visit | Posted | Mean | Full Range | units on a scale | 1 month |
|
|
|
| Primary | Self-esteem | Self-esteem change will be determined by patient self-evaluation using the Heatherton & Polivy State Self-Esteem (HPSS). The primary variable will be measured as improvement in self-esteem from baseline self-evaluations. Self-esteem change will be determined by patient self-evaluation using the Heatherton & Polivy State Self-Esteem (HPSS). The primary variable will be measured as improvement in self-esteem from baseline self-evaluations. A 20-item scale that measures a participant's self-esteem at a given point in time. The 20 items are subdivided into 3 components of self-esteem: (1) performance self-esteem, social self-esteem, and appearance self-esteem. All items are answered using a 5-point scale (1= not at all, 2= a little bit, 3= somewhat, 4= very much, 5= extremely). Scores range from 20-100. Scores closer to 100 indicate a more favorable outcome. | Posted | Mean | Full Range | score on a scale | 2 weeks |
|
|
|
| Secondary | Subject First Impression | Each subject will complete a 10-point (1-Not at all to 10-Very Much) scale evaluating their own first impression at Baseline and 1-month post-OCR. First impression scores were recorded at baseline and 1-month post-OCR, and an average of the two scores were reported. | Posted | Mean | Full Range | score on a scale | baseline and 1 month post-OCR (averaged) |
|
|
|
| Secondary | Assessment of Malar Deficiency | Live subject malar deficiency severity will be rated by PI at Visits 1-4 according to the SOBER scale (Weeks 1-4 correspond to Visits 1-4). SOBER Scale (Solish Beer Remington Scale): is used to grade facial rhytids in the malar region. Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Extreme Grade 5: Extreme Scores closer to 1 is a more favorable outcome, while scores closer to 5 is a less favorable outcome | Posted | Mean | Full Range | score on a scale | 1 month |
|
|
|
| Secondary | Aesthetic Improvement | Investigator will complete GAIS (Global Aesthetic Improvement Scale) at Visits 2-4 comparing overall appearance of current visit's photo to baseline photo. Worse: -1 No Change: 0 Improved: 1 Much Improved: 2 Very Much Improved: 3 | Posted | Mean | Full Range | score on a scale | 1 month |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
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| D010756 |
| Phosphoric Acids |
| D017976 | Phosphorus Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D017610 | Calcium Compounds |
| D008903 | Minerals |
| D017553 | Phosphorus Compounds |
| Title | Measurements |
|---|---|
|
| Visit 4 |
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