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

NCT06305520 | Enrolling By Invitation

• 2 other identifiers: BPLUS-NASAL-02CRIS NO. : KCT0008113
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Nasal Disease; Nasal Surgery

Keywords

Nasolabial fold; Filler; Medical Device

Outcome Measures

Primary Outcomes (1)

• 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 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

  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

  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.

  48 weeks

Study Arms (2)

Investigational Medical Device

EXPERIMENTAL

Application of the investigational medical device (SkinPlus-HYAL Implant Lidocaine)

Device: Investigational medical device (SkinPlus-HYAL Implant Lidocaine)

Active Comparator Medical Device

ACTIVE COMPARATOR

Application of the control device (RESTYLANE Lidocaine)

Device: Active Comparator: Active Comparator Medical Device (RESTYLANE Lidocaine)

Interventions

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).

Investigational Medical Device

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).

Active Comparator Medical Device

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bioplus: lead
• Seoul National University Hospital: collaborator
• Asan Medical Center: collaborator
• Soonchunhyang University Hospital: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, Jongnogu, 03080, South Korea

Location

MeSH Terms

Conditions

Nose Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Design

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

Model Details: Medical Device

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 12, 2024
• Study Start: March 10, 2023
• Primary Completion: September 30, 2024
• Study Completion: October 31, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)