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Medical Device Pivotal Study to Injection With SkinPlus-HYAL Implant Lidocaine vs RESTYLANE Lidocaine in of Nasolabial Folds | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATIONNA

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

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

NCT06305520•Bioplus

View on ClinicalTrials.gov

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).

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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
+13 more criteria

Locations (1)

Seoul National University Hospital

Seoul, Jongnogu, South Korea

Key Dates

Start Date

March 10, 2023

Primary Completion Date

September 30, 2024

Completion Date

October 31, 2024

Last Updated

March 15, 2024

Enrollment

100

ESTIMATED participants

Conditions

Nasal DiseaseNasal Surgery

Interventions

Investigational medical device (SkinPlus-HYAL Implant Lidocaine)

DEVICE

Active Comparator: Active Comparator Medical Device (RESTYLANE Lidocaine)

DEVICE

Performance of EEG During Emergence Agitation in Nasal Surgery.

NCT05654311

Nasal Surgery

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ACTIVE_NOT_RECRUITINGNA

Emergence Agitation

NCT07253428

Emergence AgitationNasal Surgery

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COMPLETEDNA

Effectiveness of Preoperative Antiseptic Preparation in Transnasal Skull Base Surgery

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 15, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Performance of EEG During Emergence Agitation in Nasal Surgery.

Emergence Agitation

Effectiveness of Preoperative Antiseptic Preparation in Transnasal Skull Base Surgery

Effect of Oropharyngeal Pack Soaked in Ketamine or Magnesium Sulphate on Post Operative Sore Throat After Nasal Surgery

Design of an Augmented Reality System by Integration of CT Scan or MRI Data With Endoscopic Images for Video-assisted Endonasal Endoscopic Surgery

Squamous Cell Carcinoma Antigen Analysis at the University Hospital Ostrava