Medical Device Pivotal Study to Injection With SkinPlus-HYAL Implant Lidocaine vs RESTYLANE Lidocaine in of Nasolabial Folds

Nasal Surgery Clinical Trial

— BPLUS-02  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06305520
• Other study ID #: BPLUS-NASAL-02
• Secondary ID: CRIS NO. : KCT00
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 10, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: March 2024
• Source: Bioplus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: October 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

• 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.

Related Conditions & MeSH terms

• Nasal Disease
• Nasal Surgery
• Nose Diseases

Intervention

Device:
• 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).
• 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).

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Jongnogu

Sponsors (4)

Lead Sponsor	Collaborator
Bioplus	Asan Medical Center, Seoul National University Hospital, Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 weeks
Secondary	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.	8, 16, 24, 48 weeks
Secondary	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.	8, 16, 24, 48 weeks
Secondary	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.	48 weeks