Purpose of this study is the demonstration of safety and efficacy of the dermal fillers DXP01 Face for restoration of moderate to severe nasolabial folds
This is a prospective, multi-center, observational, two-arm, evaluator- and subject-blinded, active-controlled, paired clinical trial for demonstration of safety and efficacy of the dermal fillers DXP01 Face for restoration of moderate to severe nasolabial folds. Besides safety aspects, evaluated immediately after the treatment, 2 weeks, 8, 16, 24, 36 and 12 months after the treatment, the performance of the dermal fillers are evaluated in the 2, 8, 16, 24, 36 weeks and 12 months follow-up by using GAIS and WSRS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
PCL Dermal Filler
HA Dermal filler
Societatea Civila Medicala Dr. Rosu
Romania, Timisoara, Romania
The difference in the WSRS (Wrinkle Severity Rating Scale) between the treatment groups at 24 weeks after device application, as evaluated by an independent assessor.
The primary objective of the study is to demonstrate the non-inferiority of DXP01 compared to Juvéderm® ULTRA 3 by assessing the mean WSRS (Wrinkle Severity Rating Scale) score at 24 weeks, as evaluated by an independent assessor, in adults with moderate to severe nasolabial folds after administration of DXP01 and Juvéderm® ULTRA 3.\[The difference of WSRS(Wrinkle Severity Rating Scales) between baseline and week 24. A positive value indicated "effective" improvement; while a value of 0 or a negative value was regarded as "ineffective" treatment. And the WSRS improvement ratio was defined as the effective improvement ratio of either group.\]
Time frame: Baseline and week 24
• Efficacy of DXP01 as assessed by difference in the mean Wrinkle Severity Rating Scale (WSRS) score
• The mean value differences in the WSRS scores between group / The investigators calculated the mean value differences in the WSRS scores\[Wrinkle severity assessment acc. to the Wrinkle Severity Rating Scale (WSRS); 1: wrinkles absent, 2: slight wrinkles, 3: moderate wrinkles, 4: severe wrinkles, 5: very severe wrinkles\]
Time frame: • At 2, 8, 16, 36 and 48 weeks after device application
• Efficacy of DXP01 as assessed by difference in the mean Global Aesthetic Improvement Scale
• The mean value differences in the GAIS scores between group / The investigators calculated the mean value differences in the GAIS scores\[GAIS: 3: very much improved, 2: much improved, 1: improved, 0 unchanged, -1: worse\] between the test
Time frame: • At 2, 8, 16, 36 and 48 weeks after device application
• Product safety 2 weeks~48 weeks
• Short- and long-term adverse effects
Time frame: • 2 weeks of treatment and during 48 weeks after treatment.
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• The mean value differences in the Pain Score Using Visual Analog Pain Scale(VAS) between
• The VAS scale uses a 100 mm line labelled at '0' with 'no pain' and '100' with 'worst pain'.
Time frame: • After 15, 30, 45, 60 minutes(Immediate post-injection)