Safety and Efficacy of Formaderm Young Dermal Filler Injection for the Correction of Moderate-to-severe Facial Wrinkles.
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Maxigen Biotech Inc.
- Enrollment
- 320
- Locations
- 2
- Primary Endpoint
- WSRS improvement ratio at 6 month post-injection
Overview
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.
Detailed Description
A prospective, parallel, two-center, non-inferior, randomized, double-blind trial was conducted in this study. It was planned to recruit 157 subjects for each group, considering a 10% dropout rate that would lead to 320 subjects overall.
Subjects eligible in the screening will be enrolled. Each patient will receive the same treatment, either Formaderm Young Dermal Filler Injection or Restylane, to correct both sides of the nasolabial fold through randomization.
Clinical efficacy will be assessed by the blinded physician using the WSRS and GAIS, as well as by subjects using GAIS. The safety issue of Formaderm Young or Restylane will be identified and recorded during the course of the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
WSRS improvement ratio at 6 month post-injection
Time Frame: Baseline and 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.
Secondary Outcomes
- GAIS score assessed by physician(Baseline, 1 month, 3month and 6month post-injection)
- Incidence of Treatment-related Adverse Events(Month 0 to month 12)
- WSRS score(Baseline and 1 month, 3month, 6month post-injection)
- GAIS score assessed by subjects(Baseline, 1 month, 3month and 6month post-injection)
- WSRS improvement ratio(Baseline, 1 month and 3month post-injection)