Trials / Completed
CompletedNCT05822778
Formaderm (Hyaluronic Acid) for Facial Soft Tissue Augmentation
Safety and Efficacy Study of Formaderm (Hyaluronic Acid) for Facial Soft Tissue Augmentation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 98 (actual)
- Sponsor
- Maxigen Biotech Inc. · Industry
- Sex
- All
- Age
- 30 Years – 65 Years
- Healthy volunteers
- Accepted
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.
Detailed description
The purpose of this study is to evaluate the safety and efficacy of Formaderm (hyaluronic acid) dermal filler injection for soft tissue augmentation. A single-centre, non-inferior, randomized, double-blind trial with a control group was conducted in this study. Every subject received the trial product and control product injections at the same time. It was planned to recruit 95 subjects with the 10% dropout rate. This clinical trial is accordance with the "Good Clinical Practice (GCP) issued by the Department of Health and ISO14155-1：2003 Clinical investigation of medical devices for human subjects - Part 1: General Requirements and carried out according to the trial proposal approved by the Tri-Service General Hospital Human Subjects Review Committee.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Formaderm Dermal Filler Injection | Dermal filler injection to facial areas |
| DEVICE | "Q-MED" RESTYLANE | Dermal filler injection to facial areas |
Timeline
- Start date
- 2014-02-13
- Primary completion
- 2015-03-15
- Completion
- 2015-06-30
- First posted
- 2023-04-21
- Last updated
- 2023-04-21
Source: ClinicalTrials.gov record NCT05822778. Inclusion in this directory is not an endorsement.