Nasolabial Folds
Conditions
Keywords
Nasolabial folds, Hyaluronic acid filler, Dermal Filler, Hyaluronic Acid
Brief summary
This study aims to demonstrate the non-inferiority of BRDE33-100 to Soonsoofill in temporarily improving moderate to severe nasolabial folds.
Detailed description
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.
Interventions
DEVICEBRDE33-100
BRDE33-100 will be injected once at Visit 2 (Baseline).
DEVICESoonsoofill
Soonsoofill will be injected once at Visit 2 (Baseline).
Sponsors
BRPharm Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
All of the following inclusion criteria must be met for a subject to be enrolled in this clinical trial. * Male or female subjects aged between 19 and 75 years, inclusive, as of the date of written informed consent. * Voluntarily decided to participate in the study and signed the informed consent form in writing * Subjects who desire improvement in nasolabial folds and have a Wrinkle Severity Rating Scale (WSRS) score of 3 or 4. * Subjects whose bilateral nasolabial folds appear visually symmetrical, although WSRS scores do not need to be identical on both sides. * Subjects who agree to use appropriate contraception from the date of signing the informed consent form until 3 months after the end of the clinical trial. \*Examples of acceptable contraception include: copper intrauterine device (IUD), hormone-releasing IUD, condoms, vasectomy, tubal ligation, spermicides, vaginal contraceptive film, subdermal implants, injectable contraceptives, female condoms, and oral contraceptives. * Subjects who agree not to undergo any procedures or treatments that may affect the nasolabial folds during the study period. * Subjects who are able to understand and comply with the study instructions and are available for the entire duration of the study.
Exclusion criteria
Subjects who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline, Week 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline, Weeks 8, Weeks 16, Weeks 36, Weeks 48 | 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. |
| Global Aesthetic Improvement Scale (GAIS) score assessed by the investigator at Weeks 8, 16, 36, and 48 after the final treatment | Weeks 8, Weeks 16, Weeks 36, Weeks 48 | 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. |
| Global Aesthetic Improvement Scale (GAIS) score assessed by the subject at Weeks 8, 16, 36, and 48 after the final treatment | Weeks 8, Weeks 16, Weeks 36, Weeks 48 | 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. |
| 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 | Baseline, Weeks 8, Weeks 16, Weeks 36, Weeks 48 | 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. |
| 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 | Baseline, Weeks 8, Weeks 16, Weeks 36, Weeks 48 | 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. |
| 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 | Baseline | 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. |
| 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 | Baseline, Weeks 8, Weeks 16, Weeks 36, Weeks 48 | 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. |
Countries
South Korea
Outcome results
None listed