Formaderm (Hyaluronic Acid) for Facial Soft Tissue Augmen... | NCT05822778

NCT05822778

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Formaderm Dermal Filler Injection	Device	Dermal filler injection to facial areas	Formaderm(FD) group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Difference of WSRS score	Based on the photographs, blinded physician rated the score of WSRS (Wrinkle Severity Rating Scales) for both group respectively. The WSRS is a 5-grade instrument for facial wrinkle, Grade 1(absent, no visible nasolabial fold; continuous skin line ) to Grade 5(extreme, extremely deep and long nasolabial fold, detrimental to facial appearance; 2-4mm visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone) And the difference of WSRS score was calculated as week 2, 4, 12 and 24 subtracted from baseline.

Eligibility Module

Eligibility Criteria

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 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.
Those who have joined other clinical trials such ass medical device related and other similar trials within the past six months.
Those with a medical history of cosmetic filling agent allergy, any type of hyaluronic acid implants, or drugs (such as antibiotics, antihistamine, non-steroidal anti-inflammatory analgesics), or those with a medical history of local anesthetic allergy.
Patients undergoing anticoagulant treatment, those who have a medical history of coagulation defects, or those taking Chinese medicine for promoting blood circulation.
Those whose medication and medical conditions are deemed unfit for inclusion in the research based on the judgment of the researcher.
Those who are unable to comply with re-visit schedule or are unwell to sign the informed consent.