Pivotal Study to Evaluate the Efficacy and Safety of Injection With LASBEAU Strong in Correction of Nasolabial Folds

NCT06310863 | Completed

• 1 other identifier: EXOCOBIO-NASAL-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Nonsurgical injectable treatments have become popular for aesthetic purposes. In recent years, cross-linked hyaluronic acid (HA) fillers containing lidocaine have been used to correct the nasolabial folds. Aim: The aim of this study was to demonstrate the efficacy and safety of a new HA filler (LASBEAU Strong) (24 mg/mL) compared with a conventional HA filler (Restylane Lyft) for the restoration of nasolabial folds. Patients/methods: A total of 72 subjects were enrolled and randomized to receive injections of the new HA filler (test group) or the conventional HA filler (control group) on the left or right side of the face. The mean value difference in the Wrinkle Severity Rating Scale (WSRS) scores at week 24 evaluated primary efficacy. The WSRS and the Global Aesthetic Improvement Scale (GAIS) at weeks 8, 16, 24, and 48 evaluated secondary efficacy. Adverse events, laboratory tests, and a check of vital signs at every visit assessed safety.

Conditions

Dermal Fillers

Keywords

LASBEAU Strong; hyaluronic acid; lidocaine; nasolabial fold

Outcome Measures

Primary Outcomes (1)

• Differences in the mean value of the Wrinkle Severity Rating Scale (WSRS) between the test group and the control group

  Differences in the mean value of the Wrinkle Severity Rating Scale (WSRS) between the test group and the control group evaluated by independent investigators

  at 24 weeks after the application of the clinical trial medical device

Secondary Outcomes (3)

• The mean value differences in the WSRS scores between the test group and the control group

  at weeks 8, 16, 24, and 48 after the filler injections

• Differences in GAIS mean values between test and control groups

  at weeks 8, 16, 24, and 48 after the filler injections

• Percentage of subjects with WSRS score improvement of at least 1 point

  at 24 and 48 weeks after medical device application

Study Arms (2)

test group

EXPERIMENTAL

The test device, LASBEAU Strong, was developed for the purpose of temporary improvement of facial nose and lip wrinkles, which is the same indication as the control device, and has a hyaluronic acid structure similar to that of Restylane® Lyft Lidocaine, and was developed using the same crosslinker, 1,4-butanediol diglycidyl ether. The test device, LASBEAU Strong, has a higher content of hyaluronic acid than the control device, Restylane® Lyft Lidocaine, but the clinical efficacy cannot be evaluated as superior because of the high content of hyaluronic acid. This is because, in addition to the content of hyaluronic acid, differences in the manufacturing process can affect the physicochemical properties and decomposition period.

Device: LASBEAU Strong or Restylane Lyft injection as hyaluronic acid fillers

control group

ACTIVE COMPARATOR

Restylane® Lyft Lidocaine, a previously licensed product with the same ingredients as the test group, was selected as the control group. Restylane® Lyft Lidocaine is a representative filler formulation that has been recognized for the temporary improvement of facial nose and lip wrinkles, and it was selected as a control group because it is similar to the clinical trial medical device in the test group, and the application site and application method are the same. The control device, Restylane® Lyft Lidocaine, is a product imported and sold by Galderma Korea, which is a bacterial fermentation product and is known as non-animal hyaluronic acid. The purpose of use is to temporarily improve the wrinkles of the nose and lips of the face.

Device: LASBEAU Strong or Restylane Lyft injection as hyaluronic acid fillers

Interventions

LASBEAU Strong or Restylane Lyft injection as hyaluronic acid fillers DEVICE

Subjects will be randomized to receive LASBEAU Strong or Restylane Lyft injections into each of the nasolabial folds on both sides. LASBEAU Strong or Restylane Lyft Injection Box

control group; test group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 1. Men and women over 19 years of age 2. Subjects who wish to temporarily improve their nasolabial folds, those who have a Wrinkle Severity Rating Scale (WSRS) of 3 or 4 points (both do not have to have the same score) 3. Subjects who agree to discontinue all dermatological treatments or treatments (filler, botulinum toxin, laser treatment, chemical exfoliation, cosmetic surgery, etc.) other than the application of clinical trial medical devices during this clinical trial period 4. Can understand and follow instructions, and participate in the pre-clinical period.
• \. Subjects who voluntarily decide to participate in this clinical trial and agree in writing to the informed consent form.

You may not qualify if:

• \. Subjects who administered anti-thrombotic agents (excluding low-dose aspirin (100 mg, up to 300 mg/day) from 2 weeks to 2 weeks after clinical trial application), Vitamin E formulation, and NSAID formulation from 1 week to 1 week after application 2. Subjects with a history of bleeding at the past or present time 3. Subjects who received CaHA (Calcium Hydroxyapatite) or Poly L-Lactide (PLA) filler treatment at the site where the clinical trial device is applied within one year from the screening date 4. Subjects who used local application agents (steroids, retinoids: medicines only) on their face within 4 weeks from the screening date or who are scheduled to use them during the clinical trial (but steroid ointment can be used for a short period of 14 consecutive days for treatment purposes) 5. Subjects who used immunosuppressants, chemotherapy drugs, or systemic corticosteroids within 12 weeks from the screening date 6. Subjectswho received treatment for wrinkle improvement or acne scars within 24 weeks from the screening date 7. Subjects who underwent skin peeling, skin regeneration, or plastic surgery (including botulinum toxin injection) on their face within 24 weeks from the screening date 8. Subjects with the permanent skin-expanding prosthesis such as a cured gel or silicone into the face 9. Subjects with a skin disease or wound infection in the face that affects this clinical trial 10. Those with an autoimmune disease or a history of it or a weakened immune system 11. Those with a history of symptoms of anaphylaxis or severe complex allergies 12. Those with a history of hypertrophic scarring or keloidosis 13. Patients with hypersensitivity to lidocaine or other amide-based local anesthetics 14. A person who has or currently has a severe clinical impairment in the cardiovascular system, digestive system, respiratory system, endocrine system and central nervous system, or has a mental illness that significantly affects this clinical trial 15. Those who participated in other clinical trials within 30 days from the date of screening and received/applied clinical trial medicines/clinical medical devices 16. Among female subjects who are likely to become pregnant, those who do not agree to use contraception\* in a medically permitted manner up to 48 weeks after the application of the clinical trial medical device
• Medically permitted contraception methods: condoms, oral contraception lasting at least three months, using contraceptives for injection or insertion, and installing intrauterine contraceptive devices, etc.
• \. Pregnant or lactating woman 18. Anyone who has any clinical significance findings deemed inappropriate for this test by the person in charge or in charge of the test as medically determined above

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan mediccal center

Seoul, Songpa-gu, 05505, South Korea

Location

Related Publications (1)

• Cho JY, Kim SH, Cho H, Park Y, Yang HJ, An JS, Won CH, Lee JH. Noninferiority Study Comparing the Efficacy and Safety of a New Hyaluronic Acid (HA) Filler Containing Lidocaine With an Existing HA Filler for the Treatment of Nasolabial Fold Wrinkles: A Randomized, Double-Blind, Split-Face Trial. J Cosmet Dermatol. 2025 Jul;24(7):e70309. doi: 10.1111/jocd.70309.

  PMID: 40620129 DERIVED

Study Officials

• Chong Hyun Won, Doctor

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: Randomized, Matched pairs, Active controlled

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 15, 2024
• Study Start: October 7, 2019
• Primary Completion: November 24, 2020
• Study Completion: November 24, 2020
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)