CompletedNot Applicable

Clinical Trial of Cross-linked Hyaluronic Acid Dermal Filler

China320 participantsStarted 2018-08-27

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 trea…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

WSRS improvement ratio at 6 month post-injection

Timeframe: Baseline and 6 month post-injection

Trial details

NCT IDNCT05935501

SponsorMaxigen Biotech Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-10-20

View on ClinicalTrials.gov More Hyaluronic Acid trials