This study aims to demonstrate the non-inferiority of BRDE33-100 to Soonsoofill in temporarily improving moderate to severe nasolabial folds.
This confirmatory clinical trial aims to demonstrate the non-inferiority of 'BRDE33-100' by comparing and evaluating the efficacy and safety of 'BRDE33-100' with 'Soonsoofill'. This study follows a split-face design in which both the investigational device and the control device are used for treatment in each subject-one on each nasolabial fold. Device allocation will be determined by opening sealed randomization envelopes prior to each treatment. Efficacy and safety assessments will be conducted for 24 weeks after the initial treatment, followed by an additional 24-week long-term follow-up period, for a total participation duration of 52 weeks. Efficacy assessments will include the Wrinkle Severity Rating Scale (WSRS), the Global Aesthetic Improvement Scale (GAIS), and a pain evaluation using the Visual Analogue Scale (VAS). Safety assessments will include adverse event monitoring, clinical laboratory testing, vital signs, and physical examinations. At each efficacy assessment visit, including the baseline, standardized photographs of the treatment area will be taken, and WSRS scoring will be performed by an independent evaluator based on these images.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
128
BRDE33-100 will be injected once at Visit 2 (Baseline).
Soonsoofill will be injected once at Visit 2 (Baseline).
Name: Wonju severance Christian hospital
Wŏnju, Gangwon-do, South Korea
Change in Wrinkle Severity Rating Scale (WSRS) score from baseline to Week 24 after the final treatment with the investigational device, as assessed by an independent evaluator
The Wrinkle Severity Rating Scale (WSRS) is a five-point grading scale ranging from 5 (extreme deep nasolabial folds) to 1 (no visible nasolabial folds). An independent evaluator assesses wrinkle severity based on photographs of the treatment area, while the investigator performs a direct visual evaluation of the same site. For the independent assessment, photographs of the nasolabial folds taken under normal lighting from the front, left, and right angles are used for evaluation.
Time frame: Baseline, Week 24
Change in WSRS score from baseline to Weeks 8, 16, 36, and 48 after the treatment with the investigational device, as assessed by an independent evaluator
The Wrinkle Severity Rating Scale (WSRS) is a five-point grading scale ranging from 5 (extreme deep nasolabial folds) to 1 (no visible nasolabial folds). An independent evaluator assesses wrinkle severity based on photographs of the treatment area, while the investigator performs a direct visual evaluation of the same site. For the independent assessment, photographs of the nasolabial folds taken under normal lighting from the front, left, and right angles are used for evaluation.
Time frame: Baseline, Weeks 8, Weeks 16, Weeks 36, Weeks 48
Change in WSRS score from baseline to Weeks 8, 16, 36, and 48 after the final treatment with the investigational device, as assessed by the investigator
The Wrinkle Severity Rating Scale (WSRS) is a five-point grading scale ranging from 5 (extreme deep nasolabial folds) to 1 (no visible nasolabial folds). An independent evaluator assesses wrinkle severity based on photographs of the treatment area, while the investigator performs a direct visual evaluation of the same site. For the independent assessment, photographs of the nasolabial folds taken under normal lighting from the front, left, and right angles are used for evaluation.
Time frame: Baseline, Weeks 8, Weeks 16, Weeks 36, Weeks 48
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Global Aesthetic Improvement Scale (GAIS) score assessed by the investigator at Weeks 8, 16, 36, and 48 after the final treatment
The Global Aesthetic Improvement Scale (GAIS) is a post-treatment assessment scale ranging from 3 (very much improved) to -1 (worse). It is used to evaluate the degree of aesthetic improvement by directly observing the treated area at each time point in comparison to the pre-treatment condition.
Time frame: Weeks 8, Weeks 16, Weeks 36, Weeks 48
Global Aesthetic Improvement Scale (GAIS) score assessed by the subject at Weeks 8, 16, 36, and 48 after the final treatment
The Global Aesthetic Improvement Scale (GAIS) is a post-treatment assessment scale ranging from 3 (very much improved) to -1 (worse). It is used to evaluate the degree of aesthetic improvement by directly observing the treated area at each time point in comparison to the pre-treatment condition.
Time frame: Weeks 8, Weeks 16, Weeks 36, Weeks 48
Proportion of subjects showing a reduction of ≥1 point in WSRS score from baseline, as assessed by an independent evaluator at Weeks 8, 16, 36, and 48 after the final treatment
The Wrinkle Severity Rating Scale (WSRS) is a five-point grading scale ranging from 5 (extreme deep nasolabial folds) to 1 (no visible nasolabial folds). An independent evaluator assesses wrinkle severity based on photographs of the treatment area, while the investigator performs a direct visual evaluation of the same site. For the independent assessment, photographs of the nasolabial folds taken under normal lighting from the front, left, and right angles are used for evaluation.
Time frame: Baseline, Weeks 8, Weeks 16, Weeks 36, Weeks 48
Proportion of subjects showing a reduction of ≥1 point in WSRS score from baseline, as assessed by the investigator at Weeks 8, 16, 36, and 48 after the final treatment
The Wrinkle Severity Rating Scale (WSRS) is a five-point grading scale ranging from 5 (extreme deep nasolabial folds) to 1 (no visible nasolabial folds). An independent evaluator assesses wrinkle severity based on photographs of the treatment area, while the investigator performs a direct visual evaluation of the same site. For the independent assessment, photographs of the nasolabial folds taken under normal lighting from the front, left, and right angles are used for evaluation.
Time frame: Baseline, Weeks 8, Weeks 16, Weeks 36, Weeks 48
Mean pain score assessed by the subject using a 100 mm visual analogue scale (VAS) at 30 minutes after the initial treatment with the investigational device
The Visual Analog Scale (VAS) is a 100 mm vertical line with the left end labeled as "no pain (0 points)" and the right end labeled as "unbearable pain (10 points)." The subject marks a point on the line to indicate their perceived level of pain, and the distance from the 0-point to the marked line is measured in millimeters. The score is recorded in 1 mm increments, with lower scores indicating less pain.
Time frame: Baseline