Safety and Efficacy Study of Formaderm (Hyaluronic Acid) for Facial Soft Tissue Augmentation
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Maxigen Biotech Inc.
- Enrollment
- 98
- Primary Endpoint
- WSRS improvement ratio at week 24 post-injection
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
WSRS improvement ratio at week 24 post-injection
Time Frame: Baseline and week 24
The difference of WSRS(Wrinkle Severity Rating Scales) between baseline and week 24. 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.
Secondary Outcomes
- Difference of WSRS score(Baseline to week 24 post-injection)
- GAIS score(Baseline to week 24 post-injection)
- Difference of Satisfaction of treatment(Baseline to week 24 post-injection)
- Incidence of Treatment-related Adverse Events(week 0 to week 52)