Clinical Trial of Cross-linked Hyaluronic Acid Dermal Filler

June 29, 2023 updated by: Maxigen Biotech Inc.

Safety and Efficacy of Formaderm Young Dermal Filler Injection for the Correction of Moderate-to-severe Facial Wrinkles.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
320

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chaoyang
      • Beijing, Chaoyang, China, 100029
        • Beijing Anzhen Hospital, Capital Medical University
    • Tongren
      • Beijing, Tongren, China, 100005
        • Beijing Tongren Hospital, Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Formaderm Young
Formaderm Young was randomly administered to subjects. The injection volume was limited to 2c.c.
Device: Formaderm Young
Dermal filler injection to facial areas.
Active Comparator: Restylane
Restylane was randomly administered to subjects. The injection volume was limited to 2c.c.
Device: Restylane
Dermal filler injection to facial areas.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and 6 month post-injection

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
WSRS score
Time Frame: Baseline and 1 month, 3month, 6month post-injection
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
WSRS improvement ratio
Time Frame: Baseline, 1 month and 3month post-injection
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
GAIS score assessed by physician
Time Frame: Baseline, 1 month, 3month and 6month post-injection
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
GAIS score assessed by subjects
Time Frame: Baseline, 1 month, 3month and 6month post-injection
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
Incidence of Treatment-related Adverse Events
Time Frame: Month 0 to month 12
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maxigen Biotech Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 27, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 20, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 6, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MBI-2016-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hyaluronic Acid

Clinical Trials on Formaderm Young

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings