Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05935501
Other study ID # MBI-2016-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 27, 2018
Est. completion date April 6, 2023

Study information

Verified date June 2023
Source Maxigen Biotech Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 320
Est. completion date April 6, 2023
Est. primary completion date October 20, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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. - Patients taking antiplatelet medicine that could affect platelet function, such as Aspirin or non-steroidal anti-inflammatory analgesics. - Those with a allergy history of cosmetic filling agent, any type of hyaluronic acid implants or local anesthetic. - Those who have undergone facial cosmetic treatments or surgery before the trial: - Chemical or physical treatments that affect local configuration before the trial, such as laser procedures, skin resurfacing, chemical peel or Face Wrinkle Correction Surgery within 6 month. - Facial surgery or dermal filler at nasolabial fold area within 12 month. - Those who have cosmetic surgery with silicone in their body or material that cannot be absorbed by the body (permanent filling agent). - Those who are not willing to avoid undergoing other cosmetic treatment and surgery, such as facial filling, botulinum toxin Injection, laser procedures, chemical peel or facelift surgery. - Those who have participate in another clinical investigation within 12 month. - Those who are deemed unfit for inclusion.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Formaderm Young
Dermal filler injection to facial areas.
Restylane
Dermal filler injection to facial areas.

Locations

Country Name City State
China Beijing Anzhen Hospital, Capital Medical University Beijing Chaoyang
China Beijing Tongren Hospital, Capital Medical University Beijing Tongren

Sponsors (1)

Lead Sponsor Collaborator
Maxigen Biotech Inc.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary WSRS improvement ratio at 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. Baseline and 6 month post-injection
Secondary WSRS score 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). Baseline and 1 month, 3month, 6month post-injection
Secondary WSRS improvement ratio The difference of WSRS(Wrinkle Severity Rating Scales) between baseline and 1 month and 3 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. Baseline, 1 month and 3month post-injection
Secondary GAIS score assessed by physician Compared with the baseline photographs, blinded physician rated the class of GAIS(Global Aesthetic Improvement Scale) from 5(exceptional improvement, excellent corrective result) to 1(worsened patient, the appearance has worsened compared with the original condition) for both group at 1 month, 3 month and 6 month post-injection respectively. Baseline, 1 month, 3month and 6month post-injection
Secondary GAIS score assessed by subjects Compared with baseline, subjects themselves rated the class of GAIS(Global Aesthetic Improvement Scale) from 5(exceptional improvement, excellent corrective result) to 1(worsened patient, the appearance has worsened compared with the original condition) for both group at 1 month, 3 month and 6 month post-injection respectively. Baseline, 1 month, 3month and 6month post-injection
Secondary Incidence of Treatment-related Adverse Events The adverse events are defined as any unfavorable sign occurrence in a subject after treatment. The investigator assesses the severity and the relationship of each event to the use of the study device. Month 0 to month 12
See also
  Status Clinical Trial Phase
Recruiting NCT04586361 - Prospective Analysis of Introperative RegenLab PRP and Hyaluronic Acid in Patients With Knee ACL Tear Phase 4
Not yet recruiting NCT05579522 - Clinical Evaluation of Interdental Papilla Reconstruction Using Injectable Autogenous Fat Versus Hyaluronic Acid Filler. N/A
Recruiting NCT05682833 - Adjunctive Use Of A Novel Hyaluronic Acid/Chlorhexidine Gel In The Non Surgical Treatment Of Periodontitis N/A
Completed NCT06451406 - Hyaluronic Acid Injection in the Glans Penis Versus Selective Serotonin Reuptake Inhibitors for Lifelong Premature N/A
Not yet recruiting NCT05055557 - The Role and Mechanism of O-GlcNAc Glycosylation Modified HAS2 in the Hyaluronic Acid Synthesis in ARDS
Completed NCT05201040 - Evaluate the Safety and Effectiveness of Mannitol-combined Hyaluronan Supplement in the Treatment of Knee OA N/A
Terminated NCT05082480 - Evaluate the Effectiveness of Crosslinked HA on the Adhesion Preventing After Trigger Finger Release Surgery N/A
Not yet recruiting NCT05855070 - Intralesional Hyaluronic Acid and Verapamil Injection in Peyronie's Disease N/A
Not yet recruiting NCT06379997 - Oral Supplementation Compared With Hyaluronic Acid Infiltration in Rotator Cuff Tendinopathies N/A
Completed NCT04812457 - Hyaluronic Acid in Postoperative Cures in the Phenol/Alcohol Technique Early Phase 1
Recruiting NCT05990049 - Hyaluronic Acid and Free Gingival Graft Healing Phase 3
Recruiting NCT06077981 - Comparison of 0.4% Hyaluronic Acid Solution Versus Hydroxyethylamide Solution in Submucosal Endoscopic Resections N/A
Completed NCT05881330 - ArtiAid® for Knee Osteoarthritis: A Post-market Study N/A
Completed NCT05294562 - China Post-Market Clinical Follow-up of FACILLE®
Completed NCT05935449 - The Clinical Trial of Difference Between Formaderm Lidocaine and Formaderm Dermal Filler Injection N/A
Recruiting NCT05039463 - Efficacy at One Year of Combined Injections of Plasma Rich in Platelets and Hyaluronic Acid in Knee Osteoarthritis
Completed NCT04569045 - Evaluate the Safety and Effectiveness of Sodium Hyaluronate When Used for the Correction of Nasolabial Folds N/A
Completed NCT05881317 - ArtiAid® Plus for Knee Osteoarthritis: A Post-market Study N/A
Not yet recruiting NCT05962619 - Arthrocentesis Alone Versus Arthrocentesis With Hyaluronic Acid Injection N/A
Completed NCT04622085 - The Evaluation of the Safety and Effectiveness of ANIMERS Chiara LA and JUVÉDERM VOLUMA® for Aging Mid-Face N/A