Clinical Evidence
The safety and efficacy of the Ellansé™ dermal filler Family has been studied in a two-year, prospective, randomized clinical study for the correction of nasolabial folds. The study was performeddone at the Hautok clinic (Munich, Germany) by Dr. Marion Moers-Carpi.
The two-year clinical study data confirmed the unique efficacy and safety profile of the Ellansé Family and will be presented in scientific publications. All data and statistical analysis were performed by the Clinical Research Organization (CRO) Alquest Inc., Minneapolis, USA.
Sustained Performance using Wrinkle Severity Rating Scale (WSRS)
The resulting WSRS scores show Sustained Improvement, statistically proven at 3, 6, 9 and 12 months as compared to baseline (using a repeated analysis of variance (R-ANOVA) model (intercept T = 0.65; p=0.5229)). This demonstrates the ‘Sustained Performance’ of Ellansé™.
Clinically significant performance using Wrinkle Severity Rating Scale (WSRS)
At twelve months an average WSRS improvement of more than one demonstrates the clinically significant performance of Ellansé™.
Sustained Performance using Global Aesthetic Improvement Scales (GAIS)
‘Sustained Performance’ is statistically proven using investigator as well as subjects GAIS showing improvement in more than 90% of patients at 3, 6, 9 and 12 months (using the generalized estimation equation (GEE) model (intercept T = 11.07, 5.65; p=<0.0001, 0.0003).
Sustained Quality of Improvement using Global Aesthetic Improvement Scales (GAIS)
The uniqueness of Ellansé™ is demonstrated via the improvement break-up analysis which demonstrates that the ‘quality of improvement’ is sustained.
Investigator Evaluated GAIS
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Patient Satisfaction Ratings
Patient satisfaction demonstrates very high ratings of more than 95% at twelve months and are consistent through the duration of action of the products (once again highlighting Sustained Performance)
