Injectable Filler for Cheek Flattening
This study has been completed.
Merz Aesthetics Inc.
Information provided by (Responsible Party):
Steven H. Dayan, DeNova Research
First received: October 19, 2010
Last updated: September 27, 2012
Last verified: September 2012
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 Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||An Open-label, Prospective, Postmarket Study to Assess Altering First Impressions and Self-esteem Following Radiesse® Injections.|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by DeNova Research:
Primary Outcome Measures:
- Blinded Evaluations of First Impression [ Time Frame: After the 1-month post optimal correction visit for subject 20 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Subject First Impression [ Time Frame: baseline, Visit 2, Visit3, and Visit 4 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Subject and Investigator will complete GAIS at Visits 2-4 comparing overall appearance of current visit's photo to baseline photo
|Study Start Date:||August 2010|
|Study Completion Date:||October 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01225354
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
Sponsors and Collaborators
Merz Aesthetics Inc.
|Principal Investigator:||Steven H Dayan, MD||DeNova Research/ Chicago Center for Facial Plastic Surgery|