Formaderm (Hyaluronic Acid) for Facial Soft Tissue Augmentation

NCT05822778 | Completed

• 1 other identifier: 2-102-05-113
• Study Type: interventional
• Target: 98
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dermal Filler

Keywords

hyaluronic acid filler; nasolabial folds

Outcome Measures

Primary Outcomes (1)

• WSRS improvement ratio at week 24 post-injection

  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.

  Baseline and week 24

Secondary Outcomes (4)

• 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

Study Arms (2)

Formaderm(FD) group

EXPERIMENTAL

Formaderm was randomly administered either side of subjects' facial areas once. The injection volume was limited to 2c.c.

Device: Formaderm Dermal Filler Injection

control group

ACTIVE COMPARATOR

As a self-controlled study, "Q-MED" RESTYLANE would be administered on the other side after injected Formaderm. The injection volume was limited to 2c.c.

Device: "Q-MED" RESTYLANE

Interventions

Formaderm Dermal Filler Injection DEVICE

Dermal filler injection to facial areas

Formaderm(FD) group

"Q-MED" RESTYLANE DEVICE

Dermal filler injection to facial areas

control group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 connective tissue diseases.
• Those with diabetes or systemic disease that cannot be controlled.
• Those suffering from human immunodeficiency syndrome.
• Those suffering from immunity related disorder or have had immune system degradation in the past.
• Those with a scar-prone constitution, prone to scar formation or hypertrophic scars.

Sponsors & Collaborators

• Maxigen Biotech Inc.: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 21, 2023
• Study Start: February 13, 2014
• Primary Completion: March 15, 2015
• Study Completion: June 30, 2015
• Last Updated: April 21, 2023

Record last verified: 2023-04