Injectable Filler for Cheek Flattening
|ClinicalTrials.gov Identifier: NCT01225354|
Recruitment Status : Completed
First Posted : October 21, 2010
Results First Posted : September 28, 2012
Last Update Posted : October 4, 2012
|Condition or disease||Intervention/treatment||Phase|
|Malar Deficiency||Drug: Calcium hydroxylapatite||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||An Open-label, Prospective, Postmarket Study to Assess Altering First Impressions and Self-esteem Following Radiesse® Injections.|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||October 2011|
Experimental: Calcium hydroxylapatite
Subject will be treated at baseline and, if needed, at 2 weeks.
Drug: Calcium hydroxylapatite
Subjects will be treated to full correction at visit 1 and, if needed, a touch-up injection at 2 weeks.
- Blinded Evaluations of First Impression [ Time Frame: After the 1-month post optimal correction visit for subject 20 ]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 each of the 20 subjects. The 10-point (1=Not at all to 10=Extremely well) First Impression Scales consisting of 8 criteria.
- Self-esteem [ Time Frame: 1 month post-optimal cosmetic result ]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 [ Time Frame: 2 weeks post optimal cosmetic result ]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.
- Subject First Impression [ Time Frame: baseline, Visit 2, Visit3, and Visit 4 ]Each subject will complete the 10-point (1-Not at all to 10-Very Much) evaluating their own first impression at Baseline, Visit 2 (if applicable), Visit 3, and Visit 4.
- Assessment of Malar Deficiency [ Time Frame: Visit 1-4 ]Live subject malar deficiency severity will be rated by PI at Visits 1-4 according to the SOBER scale.
- Aesthetic Improvement [ Time Frame: Visit 2-4 ]Subject and Investigator will complete GAIS at Visits 2-4 comparing overall appearance of current visit's photo to baseline photo
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01225354
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Steven H Dayan, MD||DeNova Research/ Chicago Center for Facial Plastic Surgery|