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

NCT07069920 | Active Not Recruiting

• 1 other identifier: Revitrane HA24-01
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to demonstrate the non-inferiority of BRDE33-100 to Soonsoofill in temporarily improving moderate to severe nasolabial folds.

Conditions

Nasolabial Folds

Keywords

Nasolabial folds; Hyaluronic acid filler; Dermal Filler; Hyaluronic Acid

Outcome Measures

Primary Outcomes (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

  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.

  Baseline, Week 24

Secondary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

The experimental group

EXPERIMENTAL

BRDE33-100

Device: BRDE33-100

The control group

ACTIVE COMPARATOR

Soonsoofill

Device: Soonsoofill

Interventions

BRDE33-100 DEVICE

BRDE33-100 will be injected once at Visit 2 (Baseline).

The experimental group

Soonsoofill DEVICE

Soonsoofill will be injected once at Visit 2 (Baseline).

The control group

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Received antithrombotic agents (except for low-dose aspirin \[100 mg, up to 300 mg/day\]) or nonsteroidal anti-inflammatory drugs (NSAIDs) within 2 weeks prior to screening
• Used topical agents on the device application area within 4 weeks prior to screening or plans to use them during the study period, including corticosteroids, retinoids, alpha hydroxy acids, skin-whitening agents, or anti-wrinkle functional cosmetics. (- Topical corticosteroids for therapeutic purposes may be used for a short duration of up to 14 consecutive days.)
• Received invasive laser treatment, deep peeling procedures, or filler injections on the device application area within 24 weeks prior to screening.
• Received any wrinkle improvement procedures on the device application area within 24 weeks prior to screening, including:
• Botulinum toxin injections
• Soft-tissue augmentation
• Facial lifting surgery
• Dermabrasion
• Dermal photo-rejuvenation
• Received any wrinkle improvement procedures on the device application area within 1 year prior to screening, including facial augmentation using calcium hydroxylapatite or wrinkle treatment using approved fillers.
• Received an injection of calcium hydroxylapatite in the nasolabial fold area within 1 year prior to screening.
• Has permanent dermal implants such as Softform or silicone in the nasolabial fold area.
• Underwent facial lifting involving thread-based tissue fixation (e.g., thread lifting) that affected the nasolabial fold area within 1 year prior to screening
• Has taken medications that may affect skin hypersensitivity testing, including:
• ① First- or second-generation antihistamines (e.g., chlorpheniramine, hydroxyzine, cetirizine, fexofenadine, loratadine) within 7 days prior to screening

Sponsors & Collaborators

• BRPharm Co., Ltd.: lead

Study Sites (1)

Name: Wonju severance Christian hospital

Wŏnju, Gangwon-do, 26426, South Korea

Location

Study Officials

• Jiye Kim, M.D., PhD

  Wonju Severance Christian Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 17, 2025
• Study Start: November 14, 2024
• Primary Completion: June 25, 2025
• Study Completion: May 1, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)