Effectiveness: The purpose of this study is to demonstrate the non-inferiority of Radiesse (CaHA) to Restylane (HA) following subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as NLFs. Safety: To evaluate the incidence and type of adverse events and serious adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
134
Subdermal injection.
Subdermal injection.
Peking University First Hospital, Merz Investigational Site #0860003
Beijing, China
Peking University Third Hospital, Merz Investigational Site #0860009
Beijing, China
The Third Affiliated Hospital, Sun Yat-Sen University, Merz Investigational Site #0860023
Guangzhou, China
Change From Baseline to Week 24 on the Wrinkle Severity Rating Scale (WSRS)
Severity of the nasolabial folds (NLFs) was assessed and measured using the 5-point Wrinkle Severity Rating Scale (WSRS), where 1=absent and 5=extreme. A lower score indicates better outcome.
Time frame: Baseline and Week 24 after last injection, up to 28 weeks
Proportion of Subjects With Improvement on the Investigator Global Aesthetic Improvement Scale (iGAIS) for Each Nasolabial Fold (NLF) at Week 24
The Investigator Global Aesthetic Improvement Scale is a subjective assessment where the treating physician describes the degree of improvement in facial appearance ranging from "Very much improved" (+3) to "Very much worse" (-3). The investigator was asked to rate each NLF separately and select the rating that best applied when asked "What is the overall impression of aesthetic change of the subject's NLF due to treatment, compared to the pretreatment photograph". Improvement was defined as a rating of +1, +2, or +3. The higher the iGAIS score, the greater the improvement. Proportion refers to percentage of participants.
Time frame: Week 24 after last injection, up to 28 weeks
Proportion of Subjects With Any Improvement on the Subject Global Aesthetic Improvement Scale (sGAIS) for Each Nasolabial Fold (NLF) at Week 24
The Subject Global Aesthetic Improvement Scale is a subjective self-assessment where the subject independently describes the degree of improvement in facial appearance ranging from "Very much improved" (+3) to "Very much worse" (-3). Subjects rated each NLF separately when asked "What is the overall impression of aesthetic change of your NLF due to treatment, compared to the pretreatment photograph?" Improvement is defined as a rating of +1, +2, or +3. The higher the sGAIS score, the greater the improvement. Proportion refers to percentage of participants.
Time frame: Week 24 after last injection, up to 28 weeks
Number of Subjects With Treatment-emergent Adverse Events (AE) Related to Radiesse
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Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Merz Investigational Site #0860030
Hangzhou, China
Zhejiang Provincial People's Hospital, Merz Investigational Site #0860005
Hangzhou, China
Zhongda Hospital Southeast University, Merz Investigational Site #0860022
Nanjing, China
RenMin Hospital of Wuhan University, Merz Investigational Site #0860014
Wuhan, China
Defined as AEs with onset at or after date of first administration of Radiesse. An AE was considered to be "related" if a causal relationship between Radiesse or the treatment procedure and the AE is at least reasonably possible.
Time frame: Baseline to week 48 after last injection, up to 52 weeks