NCT07069920

To Evaluate the Efficacy and Safety of 'BRDE33-100' for the Temporary Correction of Moderate to Severe Nasolabial Folds

Single-center, Randomized, Subject/Evaluator-blinded, Split-face, Active-controlled, Non-inferiority, Pivotal Clinical Trial to Compare the Safety and Efficacy Between BRDE33-100 and the Soonsoofill in Temporary Correction of Moderate to Severe Nasolabial Folds

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: BRPharm Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nasolabial Folds

Interventions

Type	Name	Description
DEVICE	BRDE33-100	BRDE33-100 will be injected once at Visit 2 (Baseline).
DEVICE	Soonsoofill	Soonsoofill will be injected once at Visit 2 (Baseline).

Timeline

• Start date: 2024-11-14
• Primary completion: 2025-06-25
• Completion: 2026-05-01
• First posted: 2025-07-17
• Last updated: 2025-07-17

Locations

1 site across 1 country: South Korea