Nasal DiseaseBPLUS-02NCT06305520
Medical Device Pivotal Study to Injection With SkinPlus-HYAL Implant Lidocaine vs RESTYLANE Lidocaine in of Nasolabial Folds
A study testing Investigational medical device (SkinPlus-HYAL Implant Lidocaine) and Active Comparator: Active Comparator Medical Device (RESTYLANE Lidocaine) in people with Nasal Disease and Nasal Surgery, run by Bioplus at 1 site in South Korea.
Trial summary
Purpose : This investigation intends to demonstrate that the investigational device, SkinPlus-HYAL Implant Lidocaine, is non-inferior to the comparator device, RESTYLANE Lidocaine, in terms of temporary wrinkle reduction effect, safety, and injection site pain when applied on nasolabial folds in adults. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nasal Disease, Nasal Surgery
- What is being tested?
- Investigational medical device (SkinPlus-HYAL Implant Lidocaine) and Active Comparator: Active Comparator Medical Device (RESTYLANE Lidocaine)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Mar 2023to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women 19 years of age or older
- Seeking temporary improvement of bilateral nasolabial folds, with a Wrinkle Severity Rating Scale (WSRS) score of 3 or 4 (does not have to be the same on both sides)
- Agrees to discontinue all dermatologic procedures or treatments (fillers, botulinum toxin, laser treatments, chemical peels, surgery for cosmetic purposes, etc.) other than investigational device application, including facial wrinkle improvement
- Able to understand and follow instructions and able to participate in all periods of the investigation
- Made a voluntary decision to participate in this investigation and gave written informed consent
Who cannot join
- Took antithrombotic agents (except low-dose aspirin (100 mg, maximum 300 mg/day)) from 2 weeks before to 2 weeks after application of the investigational device; took vitamin E formulations or NSAID formulations from 1 week before to 1 week after application
- History of bleeding disorder in the past or at the time of screening
- CaHA (Calcium Hydroxyapatite) or PLLA (Poly L-Lactide) filler treatment at the site of application of the investigational medical device within 1 year before the screening date
- Has used or intends to use topical agents (steroids, retinoids: medicines only, excluding cosmetics) on the facial area within 4 weeks before the screening date or during the clinical trial period (however steroid ointments for therapeutic purposes may be used for a short period of time within 14 consecutive days).
- Used immunosuppressants, chemotherapeutic agents, or systemic corticosteroids within 12 weeks before the screening date.
- Received any anti-wrinkle or acne scar treatment within 24 weeks before the screening date.
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- Received dermabrasion, skin resurfacing, or cosmetic surgery (including botulinum toxin injections) to the facial area within 24 weeks before the screening date
- Permanent skin augmentation implants such as hardened gel (Softform) or silicone in the facial area
- Skin diseases or wound infections in the facial area that would affect this investigation
- History of autoimmune disease
- Hypersensitivity to sodium hyaluronate
- History of streptococcal disease
- History of anaphylaxis or severe multiple allergies
- History of hypertrophic scars, hyperpigmentation or keloids
- Hypersensitivity to lidocaine or other amide local anesthetics
- Coagulation disorders
- Clinically significant disorders of the cardiovascular, digestive, respiratory, endocrine, or central nervous systems or a psychiatric illness that significantly affects this investigation
- Participated in another clinical investigation within 30 days before the screening date and received/applied an investigational drug/investigational medical device
- Female subjects of childbearing potential who do not agree to use a medically acceptable method of contraception* until 48 weeks after application of the investigational medical device in this investigation. (*Medically accepted methods of contraception include: condoms, oral contraception continued for at least 3 months, use of injectable or insertable contraceptives, intrauterine contraceptive devices, etc.)
- Pregnant or lactating women
- Used steroid medication for therapeutic purposes (immune diseases, musculoskeletal diseases, etc.) within 4 weeks prior to enrollment in the investigation, or plans to use steroid medication during the investigation period
- Used or intends to use functional cosmetics for wrinkle improvement within 4 weeks before participation in the investigation or during the investigation period
- In addition to the above, those who have clinical significant findings that are considered inappropriate for this investigation by the principal investigator or personnel in charge, based on medical judgment.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Jongnogu, 03080
About this study
Official title: Medical Device Pivotal Study to Evaluate the Efficacy and Safety of Injection With SkinPlus-HYAL Implant Lidocaine as Compared to RESTYLANE Lidocaine in Temporary Correction of Nasolabial Folds
Purpose : This investigation intends to demonstrate that the investigational device, SkinPlus-HYAL Implant Lidocaine, is non-inferior to the comparator device, RESTYLANE Lidocaine, in terms of temporary wrinkle reduction effect, safety, and injection site pain when applied on nasolabial folds in adults.
Design : 24-week efficacy and safety evaluation and additional 48-week long-term safety and efficacy evaluation with a multi-center, randomized, subject- \& evaluator-blind, matched pairs, active controlled, none-inferiority, confirmatory design
Read more
Treatment Group: Application of the investigational medical device (SkinPlus-HYAL Implant Lidocaine) Control Group: Application of the comparator device (RESTYLANE Lidocaine)
Population: Number of subject 100
- In this investigation, the same subject receives both test and control treatments, one on each side of the nasolabial folds (matched pairs design).
- Conditions
- Nasal Disease, Nasal Surgery
- Being tested
- Investigational medical device (SkinPlus-HYAL Implant Lidocaine), Active Comparator: Active Comparator Medical Device (RESTYLANE Lidocaine)
- Keywords
- Nasolabial fold, Filler, Medical Device
- Medical subject headings
- Nose Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational medical device (SkinPlus-HYAL Implant Lidocaine)Device
- In this investigation, the same subject receives both test and control treatments, one on each side of the nasolabial folds (matched pairs design).
Active Comparator: Active Comparator Medical Device (RESTYLANE Lidocaine)Device
- In this investigation, the same subject receives both test and control treatments, one on each side of the nasolabial folds (matched pairs design).
| Study group | Role | What they receive |
|---|---|---|
| Investigational Medical Device | Experimental | Application of the investigational medical device (SkinPlus-HYAL Implant Lidocaine) Receives: Device: Investigational medical device (SkinPlus-HYAL Implant Lidocaine) |
| Active Comparator Medical Device | Active comparator | Application of the control device (RESTYLANE Lidocaine) Receives: Device: Active Comparator: Active Comparator Medical Device (RESTYLANE Lidocaine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the mean values of the Wrinkle Severity Rating Scale (WSRS) between the treatment and control groups as evaluated by an independent evaluator at 24 weeks after the application of the investigational medical device
Descriptive statistics (number of observed subjects, mean, standard deviation, median, minimum, and maximum) for WSRS scores assessed by independent evaluators at 24 weeks after clinical trial device application by treatment group are presented. If the upper limit of the 97.5% one-sided confidence interval by t-distribution is less than 0.29 for the difference between treatment groups (test-control), it is judged that the non-inferiority of the test group has been demonstrated compared to the control group.
WSRS is a measure of wrinkles from a minimum of 0 to a maximum of 5, and the higher the score, the deeper the wrinkles.
Measured: 24 weeks
Secondary outcomes (3)
Difference in the mean values of the WSRS between the treatment and control groups as evaluated by the investigator at 8, 16, 24, and 48 weeks after device application
Descriptive statistics of WSRS scores (number of observed subjects, mean, standard deviation, median, minimum, and maximum) evaluated by test subjects at 8, 16, 24, and 48 weeks after medical device application for each treatment group are presented and analyzed by Wilcoxon's rank sum test if there is a difference between the administration groups.
WSRS is a measure of wrinkles from a minimum of 0 to a maximum of 5, and the higher the score, the deeper the wrinkles.
Measured: 8, 16, 24, 48 weeks
Difference in the mean Global Aesthetic Improvement Scale (GAIS) values between the treatment and control groups as evaluated by the investigator at weeks 8, 16, 24, and 48 of the first post-device application phase compared to before application
Descriptive statistics of GAIS scores (number of observed subjects, mean, standard deviation, median, minimum, and maximum values) evaluated by test subjects at 8, 16, 24, and 48 weeks after medical device application are presented for each treatment group and analyzed by Wilcoxon's rank sum test if there is a difference between the administration groups.
GAIS is satisfaction with device usage from a minimum of 0 to a maximum of 5 points, and the higher the score, the higher the satisfaction.
Measured: 8, 16, 24, 48 weeks
Difference in the mean values of the WSRS between the treatment and control groups as evaluated by an independent evaluator at 48 weeks after device application.
Descriptive statistics of WSRS scores (number of observed subjects, mean, standard deviation, median, minimum, and maximum) evaluated by test subjects at 8, 16, 24, and 48 weeks after medical device application for each treatment group are presented and analyzed by Wilcoxon's rank sum test if there is a difference between the administration groups.
WSRS is a measure of wrinkles from a minimum of 0 to a maximum of 5, and the higher the score, the deeper the wrinkles.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start10 Mar 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal DiseaseStudies 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
- Model description
- Medical Device
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioplus
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital, Asan Medical Center, Soonchunhyang University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305520
- Sponsor's protocol ID
- BPLUS-NASAL-02
- Other IDs
- CRIS NO. : KCT0008113
- Acronym
- BPLUS-02
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2024
- Last updated
- 15 Mar 2024
- 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 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Device Pivotal Study to Evaluate the Efficacy and Safety of Injection With SkinPlus-HYAL Implant Lidocaine as Compared to RESTYLANE Lidocaine in Temporary Correction of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT06305520
- Acronym / sponsor ID
- BPLUS-02 / BPLUS-NASAL-02
- Conditions
- Nasal Disease, Nasal Surgery
- Keywords
- Nasolabial fold, Filler, Medical Device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- BioplusIndustry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital, Asan Medical Center, Soonchunhyang University Hospital
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 12 Mar 2024 (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.
Purpose : This investigation intends to demonstrate that the investigational device, SkinPlus-HYAL Implant Lidocaine, is non-inferior to the comparator device, RESTYLANE Lidocaine, in terms of temporary wrinkle reduction effect, safety, and injection site pain when applied on nasolabial folds in adults.
Design : 24-week efficacy and safety evaluation and additional 48-week long-term safety and efficacy evaluation with a multi-center, randomized, subject- \& evaluator-blind, matched pairs, active controlled, none-inferiority, confirmatory design
Treatment Group: Application of the investigational medical device (SkinPlus-HYAL Implant Lidocaine) Control Group: Application of the comparator device (RESTYLANE Lidocaine)
Population: Number of subject 100
- In this investigation, the same subject receives both test and control treatments, one on each side of the nasolabial folds (matched pairs design).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Medical Device
| Arm | Type | Receives |
|---|---|---|
| Investigational Medical Device | Experimental | Device: Investigational medical device (SkinPlus-HYAL Implant Lidocaine)Application of the investigational medical device (SkinPlus-HYAL Implant Lidocaine) |
| Active Comparator Medical Device | Active comparator | Device: Active Comparator: Active Comparator Medical Device (RESTYLANE Lidocaine)Application of the control device (RESTYLANE Lidocaine) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women 19 years of age or older
- Seeking temporary improvement of bilateral nasolabial folds, with a Wrinkle Severity Rating Scale (WSRS) score of 3 or 4 (does not have to be the same on both sides)
- Agrees to discontinue all dermatologic procedures or treatments (fillers, botulinum toxin, laser treatments, chemical peels, surgery for cosmetic purposes, etc.) other than investigational device application, including facial wrinkle improvement
- Able to understand and follow instructions and able to participate in all periods of the investigation
- Made a voluntary decision to participate in this investigation and gave written informed consent
Key exclusion criteria (23 listed)
- Took antithrombotic agents (except low-dose aspirin (100 mg, maximum 300 mg/day)) from 2 weeks before to 2 weeks after application of the investigational device; took vitamin E formulations or NSAID formulations from 1 week before to 1 week after application
- History of bleeding disorder in the past or at the time of screening
- CaHA (Calcium Hydroxyapatite) or PLLA (Poly L-Lactide) filler treatment at the site of application of the investigational medical device within 1 year before the screening date
- Has used or intends to use topical agents (steroids, retinoids: medicines only, excluding cosmetics) on the facial area within 4 weeks before the screening date or during the clinical trial period (however steroid ointments for therapeutic purposes may be used for a short period of time within 14 consecutive days).
- Used immunosuppressants, chemotherapeutic agents, or systemic corticosteroids within 12 weeks before the screening date.
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 |
|---|---|---|
| Investigational medical device (SkinPlus-HYAL Implant Lidocaine)* In this investigation, the same subject receives both test and control treatments, one on each side of the nasolabial folds (matched pairs design). | Device | Investigational Medical Device |
| Active Comparator: Active Comparator Medical Device (RESTYLANE Lidocaine)* In this investigation, the same subject receives both test and control treatments, one on each side of the nasolabial folds (matched pairs design). | Device | Active Comparator Medical Device |
Primary outcome
Difference in the mean values of the Wrinkle Severity Rating Scale (WSRS) between the treatment and control groups as evaluated by an independent evaluator at 24 weeks after the application of the investigational medical device
Time frame: 24 weeks
Descriptive statistics (number of observed subjects, mean, standard deviation, median, minimum, and maximum) for WSRS scores assessed by independent evaluators at 24 weeks after clinical trial device application by treatment group are presented. If the upper limit of the 97.5% one-sided confidence interval by t-distribution is less than 0.29 for the difference between treatment groups (test-control), it is judged that the non-inferiority of the test group has been demonstrated compared to the control group. WSRS is a measure of wrinkles from a minimum of 0 to a maximum of 5, and the higher the score, the deeper the wrinkles.
3 secondary outcomes
Difference in the mean values of the WSRS between the treatment and control groups as evaluated by the investigator at 8, 16, 24, and 48 weeks after device application
Time frame: 8, 16, 24, 48 weeks
Difference in the mean Global Aesthetic Improvement Scale (GAIS) values between the treatment and control groups as evaluated by the investigator at weeks 8, 16, 24, and 48 of the first post-device application phase compared to before application
Time frame: 8, 16, 24, 48 weeks
Difference in the mean values of the WSRS between the treatment and control groups as evaluated by an independent evaluator at 48 weeks after device application.
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational medical device (SkinPlus-HYAL Implant Lidocaine) and Active Comparator: Active Comparator Medical Device (RESTYLANE Lidocaine) in people with Nasal Disease and Nasal Surgery, run by Bioplus 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?
The sponsor lists 5 inclusion and 23 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 15 Mar 2024. 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?
Results are not available in the source record.
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?
Difference in the mean values of the Wrinkle Severity Rating Scale (WSRS) between the treatment and control groups as evaluated by an independent evaluator at 24 weeks after the application of the investigational medical device (time frame: 24 weeks). 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 15 Mar 2024.