To Evaluate the Efficacy and Safety of 'BRDE33-100' for the Temporary Correction of Moderate to S… (NCT07069920) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
To Evaluate the Efficacy and Safety of 'BRDE33-100' for the Temporary Correction of Moderate to Severe Nasolabial Folds
South Korea128 participantsStarted 2024-11-14
Plain-language summary
This study aims to demonstrate the non-inferiority of BRDE33-100 to Soonsoofill in temporarily improving moderate to severe nasolabial folds.
Who can participate
Age range19 Years – 75 Years
SexALL
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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 exclusion criteria will not be eligible for participation in this clinical trial.
* Received antithrombotic agents (except for low-dose aspirin \[100 mg, up to 3…
What they're measuring
1
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