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
Males and females aged 19 to 70 years.
Subjects with nasolabial folds (NLF) on both sides scored at 3 or 4 on the WSRS (Wrinkle Severity Rating Scale) as evaluated by the investigator at screening (both sides do not need to have the same score but must fall within the 3-4 range).
Subjects with visually symmetrical nasolabial folds (NLF) on both sides.
Subjects who can comply with the clinical trial procedures and will not undergo any facial cosmetic procedures/surgeries contraindicated for combination therapy during the clinical trial.
Subjects with localized wounds or active infections (such as cysts, acne, rashes, hives, etc.) in the nasolabial fold area.
Subjects with acute, chronic, or recurrent skin conditions (whether infectious or non-infectious).
Subjects with scars or abnormal skin findings (such as moles, erythema, or telangiectasia) in the nasolabial fold area that may affect treatment outcomes.
Subjects with a history of keloid formation, hyperpigmentation, or hypertrophic scars.
Parallel
DXP01
DevicePCL Dermal Filler
Juvederm ULTRA 3
DeviceHA Dermal filler
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.\[The difference of WSRS(Wrinkle Severity Rating Scales) between baseline and week 24. A positive value indicated "effective" improvement; while a value of 0 or a negative value was regarded as "ineffective" treatment. And the WSRS improvement ratio was defined as the effective improvement ratio of either group.\]
• 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\[Wrinkle severity assessment acc. to the Wrinkle Severity Rating Scale (WSRS); 1: wrinkles absent, 2: slight wrinkles, 3: moderate wrinkles, 4: severe wrinkles, 5: very severe wrinkles\]
• 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
• Product safety 2 weeks~48 weeks
• Short- and long-term adverse effects
• 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'.
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