Evaluation of Collagen Dermal Filler With Lidocaine for the Correction of Nasolabial Folds

March 15, 2019 updated by: National Taiwan University Hospital

Evaluation of Collagen Dermal Filler With Lidocaine for the Correction of Nasolabial Folds: a Prospective, Randomized, Active-controlled, Double Blinded, Multicenter Clinical Trial

Evaluation the efficacy and safety of collagen dermal filler with lidocaine using in the middle to deep dermis for the correction of nasolabial folds.

Study Overview

Status

Status

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

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

This is a prospective, randomized, active-controlled, double blinded (blinded evaluator and subject), multicenter clinical trial, which will be performed in Tri-Service General Hospital, Linkou ChangGung Memorial Hospital and National Taiwan University Hospital. These hospitals will recruit subjects in a competitive way. 240 subjects will be recruited in total, and each hospital will recruit 60~120 subjects. The expected execution period is 2018/10~2021/06. Subjects will be randomly assigned to receive the investigational device "Sumax FULLSGEN with Lidocaine" or controlled device "Sumax FACIALGAIN collagen Implant with Lidocaine" in 1:1 ratio. These devices will be processed to keep subjects and evaluators blinded.

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 (Anticipated)

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.
240

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

  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University Hospital

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

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Bilateral defects in the nasolabial folds with grades 3 or 4 on the Wrinkle Severity Rating Scale (WSRS).
  2. Male or female aged 20 ~ 65-year-old.
  3. Willingness to receive wrinkle augment treatment.
  4. Willingness to avoid other facial beauty therapy during this clinical trial.
  5. Healthy facial skin condition, and not have any disorder that can interfere the assessment of skin aging, e.g. facial nerve disorders.
  6. All the enrolled subjects should sign and date the informed consent form before this trial starts.

Exclusion Criteria:

  1. Known history of anaphylactoid reaction and other auto-immune diseases.
  2. Known history of allergies to collagen, or those who are allergic to the control or investigational device after the verification of intradermal allergy test.
  3. Known history of allergies to lidocaine.
  4. Known coagulation disorders.
  5. Females who have positive pregnancy test at screening, plan a pregnancy, breastfeeding, and those who are unable to take contraception method.
  6. Subjects with local infection, severity skin disease, inflammation or related symptoms on the nasolabial folds. Or with keloid (hypertrophic scar).
  7. Subjects with severe cardiac, renal, hepatic, or respiratory diseases.
  8. Subjects with clinically diagnosed mental illness.
  9. According to American National Institute of Health standards, those who meet the criteria of Alcohol Use Disorder.
  10. Subjects take immunosuppressive drugs, chemotherapy, or systemic steroids (i.e. oral or injection) within 12 weeks before screening.
  11. Subjects take anticoagulant treatment or NSAIDs within 1 week before screening.
  12. Subjects have permanent implants in the nasolabial folds area.
  13. Subjects have nasolabial folds augment treatment such as autologous fat, hyaluronic acid or collagen filler implant within 52 weeks before screening.
  14. Subjects have nasolabial fold correctional procedure or treatment such as botulinum toxin injection, chemical peeling, laser at dermis or plastic surgery.
  15. Subjects unable to comply the scheduled follow-up.
  16. Subjects participate other clinical trials within 12 weeks before screening (trials only with questionnaire or specimen collection are exemption).
  17. Subjects who are not eligible for this trial based on the judgment of investigators.

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: Sunmax FULLSGEN with Lidocaine
A subject would only receive single injection treatment(day 1) using Sunmax FULLSGEN , and there would be 6 follow-up visits at 4th, 12th, 24th, 36th and 52nd week after injection treatment.
Device: Sunmax FULLSGEN with Lidocaine
Subject who voluntarily sign the informed consent form (day -14~1) will be randomly assigned to investigational or control group and have intradermal allergy test. After the injection treatment by randomly choosing the device, every subject would have 6 follow-up visits.
Other Names:
  • Sumax FACIALGAIN collagen Implant with Lidocaine
Active Comparator: Sumax FACIALGAIN collagen Implant with Lidocaine
A subject would only receive single injection treatment(day 1) using Sumax FACIALGAIN collagen Implant with Lidocaine, and there would be 6 follow-up visits at 4th, 12th, 24th, 36th and 52nd week after injection treatment.
Device: Sunmax FULLSGEN with Lidocaine
Subject who voluntarily sign the informed consent form (day -14~1) will be randomly assigned to investigational or control group and have intradermal allergy test. After the injection treatment by randomly choosing the device, every subject would have 6 follow-up visits.
Other Names:
  • Sumax FACIALGAIN collagen Implant with Lidocaine

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 score evaluation
Time Frame: 24th week. Using the 5-grade Wrinkle Severity Rating Scale (WSRS) to evaluate wrinkle, and score 5 is the worst one.
24th week response rate will be calculated according to WSRS score assessed by the evaluators Subtract the subject's WSRS baseline score from the Xth week after injection as improved score.
24th week. Using the 5-grade Wrinkle Severity Rating Scale (WSRS) to evaluate wrinkle, and score 5 is the worst one.

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 evaluation within 4 time point as assessed by the evaluators
Time Frame: 4th, 12th, 36th and 52nd week week. Using the 5-grade Wrinkle Severity Rating Scale (WSRS) to evaluate wrinkle, and score 5 is the worst one.
WSRS response rate at 4th, 12th, 36th and 52nd week as assessed by the evaluators
4th, 12th, 36th and 52nd week week. Using the 5-grade Wrinkle Severity Rating Scale (WSRS) to evaluate wrinkle, and score 5 is the worst one.
GAIS score at specific week as assessed by the subject
Time Frame: 4th, 12th, 24th, 36th and 52nd week. Global Aesthetic Improvement Scale (GAIS) is scored 5 level of improvement. Score 5 is the worst value.
GAIS score at 4th, 12th, 24th, 36th and 52nd week as assessed by the subject
4th, 12th, 24th, 36th and 52nd week. Global Aesthetic Improvement Scale (GAIS) is scored 5 level of improvement. Score 5 is the worst value.
GAIS score at specific week as assessed by the evaluators
Time Frame: 4th, 12th, 24th, 36th and 52nd week. Global Aesthetic Improvement Scale (GAIS) is scored 5 level of improvement. Score 5 is the worst value.
GAIS score at 4th, 12th, 24th, 36th and 52nd week as assessed by the evaluators
4th, 12th, 24th, 36th and 52nd week. Global Aesthetic Improvement Scale (GAIS) is scored 5 level of improvement. Score 5 is the worst value.
VAS score evaluation
Time Frame: 30 minutes. Double-sided print or photocopy the next 2 diagrams ensuring that the lines are exactly 10 cm in length and superimposed.
VAS score within 30 mins after injection as assessed by the subject
30 minutes. Double-sided print or photocopy the next 2 diagrams ensuring that the lines are exactly 10 cm in length and superimposed.
TPS score evaluation
Time Frame: 30 minutes. The score is evaluated by thermometer pain scale, and the scale is 0-10. 0 stands for on pain, and 10 stands for worst possible pain.
TPS score within 30 mins after injection as assessed by the investigator
30 minutes. The score is evaluated by thermometer pain scale, and the scale is 0-10. 0 stands for on pain, and 10 stands for worst possible pain.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety Endpoint (Evaluation of laboratory inspection values.)
Time Frame: One year. Number of participants with abnormal laboratory values and/or adverse events that are related to treatment.
Evaluation of laboratory inspection values.
One year. Number of participants with abnormal laboratory values and/or adverse events that are related to treatment.
Safety Endpoint (Evaluation of the percentage of AE and AR)
Time Frame: One year. Number of participants with AE divided by number of participants with AR is the percentage of AE and AR.
Evaluation of the percentage of AE and AR
One year. Number of participants with AE divided by number of participants with AR is the percentage of AE and AR.

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.
National Taiwan University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chang Gung Memorial Hospital
Tri-Service General Hospital

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.
March 1, 2019

Primary Completion (Anticipated)

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.
February 28, 2020

Study Completion (Anticipated)

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.
August 31, 2020

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).
January 31, 2019

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.
February 15, 2019

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.
February 18, 2019

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.
March 18, 2019

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.
March 15, 2019

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.
January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • 201809007DSA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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