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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Subjects will be treated to full correction at visit 1 and, if needed, a touch-up injection at 2 weeks.
DeNova Research
Chicago, Illinois, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 2 weeks
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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.
Time frame: baseline and 1 month post-OCR (averaged)
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
Time frame: 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
Time frame: 1 month