Comparing Pain, Safety and Effectiveness of Restylane Skinboosters Vital Lido and Vital Without Lido in Dorsal Hand

September 19, 2025 updated by: Galderma R&D

A Randomized, Split-Hand, Subject-Blinded Study Comparing Pain, Safety and Effectiveness of Restylane Skinboosters Vital Lidocaine and Restylane Vital Without Lidocaine for Improved Appearance of the Dorsal Hand in Chinese Subjects

This is a randomized, multi-center, split-hand, subject-blinded study comparing pain, safety and effectiveness of Restylane Skinboosters Vital Lidocaine and Restylane Vital without lidocaine for improving appearance of the dorsal hands in Chinese subjects.

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.

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.
90

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Galderma Research Site 01
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Galderma Research Site 02
      • Hangzhou, Zhejiang, China
        • Galderma Research Site 03

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

No

Description

Inclusion Criteria:

  1. Signed and dated informed consent to participate in the study
  2. Chinese origin
  3. Age at least 18 years
  4. The subject is willing and able to comply with the requirements of the study and agrees to adhere to the visit schedule and to be compliant to the study instructions
  5. Subjects eligible for treatment to improve appearance of the dorsal hand by increasing tissue volume
  6. Same grade of tissue degeneration and need for treatment in both hands

Exclusion Criteria:

  1. Any previous non-permanent or permanent implant/filler in the hands, including autologous fat
  2. Any mesotherapy or resurfacing procedure (laser, chemical peels or other ablative or non-ablative treatment) in the hands within 6 months prior to baseline
  3. Any previous hand surgery including sclerotherapy
  4. Any fibrosis or scarring or deformities on the hands
  5. Advanced photoaged/ photodamaged skin (e.g. advanced skin elastosis, multiple lentigo solaris lesions) or skin condition with very crinkled or fragile skin on the dorsal hands
  6. Subjects with active skin disease, inflammation or related conditions in the hand
  7. Subjects with a history of precancerous (e.g. actinic keratosis) or cancerous lesions in the hands
  8. Subjects with a history of Raynaud´s disease or phenomenon, or history of other disease that may affect peripheral circulation
  9. History of neurological disease that may affect peripheral neurological function
  10. Subjects with a history of autoimmune disease or joint disease or connective tissue disease (e.g. rheumatoid arthritis, lupus, scleroderma etc)
  11. Subjects with known hypersensitivity to any ingredient of the study product or anesthesia used in the study or with a history of any significant Adverse Events caused by dermal fillers
  12. Use of topical retinoids on the dorsal hands within 6 weeks prior to baseline or use of systemic retinoids within 6 months prior to baseline
  13. History of chronic lymph edema or breast cancer /mastectomy with potential to cause edema
  14. Concomitant thrombolytic or anticoagulant therapy and therapy with inhibitors of platelet aggregation, (e.g. non-steriod anti-inflammatory drugs, acetylsalicylic acid, Omega 3 and Vitamin E) within 2 weeks prior to treatment, or a history of bleeding disorders. Cyclooxygenase-2 (COX-2) inhibitors are allowed
  15. Treatment with chemotherapy, immunosuppressive agents, immunomodulatory therapy (e.g. monoclonal antibodies), systemic or topical (dorsal hands) corticosteroids (inhaled corticoids are allowed) within three months before study treatment
  16. History of untreated epilepsy or other significant medical conditions
  17. Women who are pregnant or breast feeding, or Woman of childbearing potential who are not practicing adequate contraception or planning to become pregnant during the study period.
  18. Subjects participating in another interventional clinical study within 30 days of baseline
  19. Subjects with unattainable expectation with regard to the aesthetic results of the treatment
  20. Subjects who are involved in conducting the study (e.g. colleagues within the same department) or close relatives to any of the study staffs (e.g. parents, children, siblings or spouse ) as well as subjects who are employed by the Sponsor company, or close relatives of employees at the Sponsor company
  21. Subjects with any other condition which in the opinion of the Investigator, might compromise the subject's ability to tolerate the injection procedure or comply with requirements of the study

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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: Restylane Skinboosters Vital Lidocaine
Participant's one hand treated by Restylane Skinboosters Vital Lidocaine
Device: Restylane Skinboosters Vital Lidocaine
Each subject will receive treatment on Day 1 with Restylane Skinboosters Vital Lidocaine in one hand and Restylane Vital in the opposite hand, as randomly assigned.
Active Comparator: Restylane Vital
Participant's another hand treated by Restylane Vital
Device: Restylane Vital
Each subject will receive treatment on Day 1 with Restylane Vital in one hand and the experimental device in the opposite hand, as randomly assigned

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
The Within-subject Difference in VAS Score (Restylane Skinboosters Vital Lidocaine- Restylane Vital) at End of Injection (T0).
Time Frame: End of Injection (T0)
The VAS is a subjective scale to measure pain intensity. Total range is 0-100, 0 represents no pain and 100 represents the worst pain you can imagine, meaning a lower value is considered a better outcome in terms of a less painful treatment. The subject shall be instructed to put a vertical mark, approximating the pain experienced after the procedure, on a 100 mm horizontal line labelled "no pain" at the left end and "the worst pain you can imagine" at the right end. The distance in mm from the left end (no pain) to the subject's VAS mark shall be measured with a standard ruler. Each hand will be evaluated independently.
End of Injection (T0)

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.
Galderma R&D

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Galderma R&D, Galderma R&D

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.
April 24, 2024

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.
June 28, 2024

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.
July 16, 2024

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).
April 15, 2024

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.
April 15, 2024

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.
April 18, 2024

Study Record Updates

Last Update Posted (Estimated)

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.
October 10, 2025

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.
September 19, 2025

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.
March 1, 2024

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.
  • 43CH2305

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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