Nasolabial FoldsNCT07069920
To Evaluate the Efficacy and Safety of 'BRDE33-100' for the Temporary Correction of Moderate to Severe Nasolabial Folds
A study testing BRDE33-100 and Soonsoofill in people with Nasolabial Folds, run by BRPharm Co., Ltd. at 1 site in South Korea.
Trial summary
This study aims to demonstrate the non-inferiority of BRDE33-100 to Soonsoofill in temporarily improving moderate to severe nasolabial folds. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Nasolabial Folds
- What is being tested?
- BRDE33-100 and Soonsoofill
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Nov 2024to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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 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 ② Tricyclic antidepressants (e.g., imipramine, doxepin) within 11 days prior to screening ③ H2-receptor antagonists (e.g., ranitidine) within 1 day prior to screening
- Has scars, skin disorders, wounds, infections, inflammation, or other skin lesions in the nasolabial fold area that may affect the outcome of this clinical trial.
- Has a history of anaphylaxis or severe systemic allergic reactions.
- Has a history of hypertrophic scarring, keloid formation, or hyperpigmentation.
- Has a known hypersensitivity to Hyaluronic acid (HA).
- Has experienced adverse reactions to EMLA Cream or other lidocaine-based anesthetic products.
- Has or has had autoimmune diseases including AIDS, or is immunocompromised.
- Has clinically significant disorders of the cardiovascular, gastrointestinal, respiratory, endocrine, or central nervous systems, or has psychiatric conditions that may affect participation in this clinical trial.
- Tested positive on the skin hypersensitivity test indicating hypersensitivity to the investigational device or control device at the time of screening.
- Participated in other clinical trial(s) within 30 days prior to screening
- Pregnant or breast-feeding women (women of childbearing potential must undergo a pregnancy test)
- Subjects who, due to physical, neurological, or psychological conditions, are unable to comply with all aspects of the screening, evaluation, treatment, and follow-up schedule.
- Subjects who are otherwise unable to communicate or follow instructions properly.
- Determined by the principal investigator to be unable to participate in the study for other reasons
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Name: Wonju severance Christian hospital
Wŏnju, Gangwon-do, 26426
About this study
Official title: 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
This study aims to demonstrate the non-inferiority of BRDE33-100 to Soonsoofill in temporarily improving moderate to severe nasolabial folds.
Read the 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
- Being tested
- BRDE33-100, Soonsoofill
- Keywords
- Nasolabial folds, Hyaluronic acid filler, Dermal Filler, Hyaluronic Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRDE33-100Device
BRDE33-100 will be injected once at Visit 2 (Baseline).
SoonsoofillDevice
Soonsoofill will be injected once at Visit 2 (Baseline).
| Study group | Role | What they receive |
|---|---|---|
| The experimental group | Experimental | BRDE33-100 Receives: Device: BRDE33-100 |
| The control group | Active comparator | Soonsoofill Receives: Device: Soonsoofill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start14 Nov 2024
- Primary completion25 Jun 2025
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial FoldsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- BRPharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jiye Kim, M.D., PhD, Principal investigator, Wonju Severance Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069920
- Sponsor's protocol ID
- Revitrane HA24-01
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07069920
- Acronym / sponsor ID
- Revitrane HA24-01
- Conditions
- Nasolabial Folds
- Keywords
- Nasolabial folds, Hyaluronic acid filler, Dermal Filler, Hyaluronic Acid
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 128 participants (actual)
- Lead sponsor
- BRPharm Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- 25 Jun 2025 (actual)
- Study completion
- May 2026 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The experimental group | Experimental | Device: BRDE33-100BRDE33-100 |
| The control group | Active comparator | Device: SoonsoofillSoonsoofill |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BRDE33-100BRDE33-100 will be injected once at Visit 2 (Baseline). | Device | The experimental group |
| SoonsoofillSoonsoofill will be injected once at Visit 2 (Baseline). | Device | The control group |
Primary outcome
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
Time frame: 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.
7 secondary outcomes
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
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
Time frame: 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
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
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
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
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
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiye Kim, M.D., PhD principal investigator
Wonju Severance Christian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BRDE33-100 and Soonsoofill in people with Nasolabial Folds, run by BRPharm Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.