CompletedNot Applicable

Formaderm (Hyaluronic Acid) for Facial Soft Tissue Augmentation

98 participantsStarted 2014-02-13

Plain-language summary

The goal of this clinical trial is to evaluate the safety and efficacy of Formaderm (hyaluronic acid) dermal filler injection for soft tissue augmentation. The main questions it aims to answer are: * The differences of Wrinkle Severity Rating Scale (WSRS) after the injection. * The differences of Global Aesthetic Improvement Scale (GAIS) after the injection. * The subjective satisfaction of treatment. * Safety Indicators of which incidences on the day of the injection or after the injection. Participants will be self-controlled and randomized for same period * received both trial product and control product at the same time. * re-visited on week 2, 4, 12, 24, 36, and 52 after injection. Researchers will compare if the test product is non-inferiority to Q-Med Restylane.

Who can participate

Age range

30 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 30-65 years old of both sexes. * Subjects who are willing to undergo WSRS therapy. * The WSRS baseline measurement should be 3-4 points and the left and right side should be in symmetry. * The facial skin is healthy, without any disease that possibly interferes with skin aging status assessment. * The subject is willing to avoid undergoing other cosmetic treatment and surgery, including Botox injection. 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 severe skin disease, inflammation, or related symptoms such as infections, psoriasis, herpes, and the like. * Those who have undergone cosmetic treatment or surgery prior to the trial: * Those who have undergone laser treatment or dermabrasion within the past 12 months. * Those who have undergone chemical peels treatment within the last three months. * Those who have undergone facial wrinkle augmentation surgery such as Botox injections within the past 12 months. * Those with silicone in their body or material that cannot be absorbed by the body (permanent filling agent). * Those who have undergone facial surgery or filing agent implants in the nasolabial fold area within the past 24 months. * Those who have a scar or localized infection in the nasolabial fold area. * Those with connecti…

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 week 24 post-injection

Timeframe: Baseline and week 24

Trial details

NCT IDNCT05822778

SponsorMaxigen Biotech Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-03-15

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