Clinical Trial of Cross-linked Hyaluronic Acid Dermal Filler

NCT05935501 | Completed

• 1 other identifier: MBI-2016-01
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to evaluate the safety and efficacy of Formaderm Young Dermal Filler Injection, which is a hyaluronic acid dermal filler injected into the mid to deep dermis for the correction of moderate-to-severe nasolabial fold facial wrinkles. The main questions it aims to answer are:

• The differences of Wrinkle Severity Rating Scale (WSRS) after the injection.
• The treatment improvement assessed by Global Aesthetic Improvement Scale (GAIS).
• Safety Indicators of which incidences on the day of the injection or after the injection. Participants will be blinded and randomized into either experiment group or control group, and re-visited on 1, 3, 6, 9 and 12 month after injection. Researchers will compare if the test product is non-inferiority to Restylane.

Conditions

Hyaluronic Acid; Dermal Fillers

Outcome Measures

Primary Outcomes (1)

• WSRS improvement ratio at 6 month post-injection

  The difference of WSRS(Wrinkle Severity Rating Scales) between baseline and 6 month post-injection. A positive value indicated"effective" improvement; while a value of 0 or a negative value was regarded as "ineffective" treatment. And the WSRS improvement ratio was defined as the effective improvement ratio of either group.

  Baseline and 6 month post-injection

Secondary Outcomes (5)

• WSRS score

  Baseline and 1 month, 3month, 6month post-injection

• WSRS improvement ratio

  Baseline, 1 month and 3month post-injection

• GAIS score assessed by physician

  Baseline, 1 month, 3month and 6month post-injection

• GAIS score assessed by subjects

  Baseline, 1 month, 3month and 6month post-injection

• Incidence of Treatment-related Adverse Events

  Month 0 to month 12

Study Arms (2)

Formaderm Young

EXPERIMENTAL

Formaderm Young was randomly administered to subjects. The injection volume was limited to 2c.c.

Device: Formaderm Young

Restylane

ACTIVE COMPARATOR

Restylane was randomly administered to subjects. The injection volume was limited to 2c.c.

Device: Restylane

Interventions

Formaderm Young DEVICE

Dermal filler injection to facial areas.

Formaderm Young

Restylane DEVICE

Dermal filler injection to facial areas.

Restylane

Eligibility Criteria

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

You may qualify if:

• Subjects are aged 18-65 years old of both sexes.
• Subjects who are willing to undergo both sides nasolabial fold therapy.
• The baseline measurement on the wrinkle severity rating scale (WSRS) should be 3-4 points, and the left and right sides should exhibit symmetry.
• Willing to comply with re-visit schedule and sign the informed consent.

You may not qualify if:

• Women subjects who are pregnant, breastfeeding, planning to become pregnant, and not willing to take contraception during the trial period.
• Those who are emotionally unstable or suffering from a mental disease.
• Those who have unhealthy facial skin or severe skin disease, inflammation, or related symptoms such as infections, psoriasis, herpes, and similar conditions.
• Those with any disease that would interfere the assessment of skin aging.
• Those who have a scar in the nasolabial fold area.
• Those with connective tissue diseases.
• Those with diabetes or systemic disease that cannot be controlled.
• Those suffering from immunity related disorder.
• Those with a scar-prone constitution.
• Patients undergoing anticoagulant treatment, those who have a medical history of coagulation defects.
• Patients taking antiplatelet medicine that could affect platelet function, such as Aspirin or non-steroidal anti-inflammatory analgesics.
• Those with a allergy history of cosmetic filling agent, any type of hyaluronic acid implants or local anesthetic.
• Those who have undergone facial cosmetic treatments or surgery before the trial:
• Chemical or physical treatments that affect local configuration before the trial, such as laser procedures, skin resurfacing, chemical peel or Face Wrinkle Correction Surgery within 6 month.
• Facial surgery or dermal filler at nasolabial fold area within 12 month.

Sponsors & Collaborators

• Maxigen Biotech Inc.: lead

Study Sites (2)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Chaoyang, 100029, China

Location

Beijing Tongren Hospital, Capital Medical University

Beijing, Tongren, 100005, China

Location

Study Design

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

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 7, 2023
• Study Start: August 27, 2018
• Primary Completion: October 20, 2021
• Study Completion: April 6, 2023
• Last Updated: July 7, 2023

Record last verified: 2023-06

Locations

CN (2)