Study to Evaluate Restylane Vital Light Using an Injector Device

August 24, 2022 updated by: Galderma R&D

An Open, Randomized, Single-centre, Intra-individual Controlled, Explorative, Safety and Efficacy Study Comparing Restylane Vital White With no Treatment in the Face, Back of the Hands and décolletage, Using an Injector Device

The purpose of the study is to evaluate the safety and efficacy of Restylane Vital White administered with an injector device on aged skin in the face, hands and décolletage.

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

The objectives are to explore the safety and efficacy profile of Restylane Vital White administered with an injector device when one side of the face, one of the hands and one side of the décolletage is treated and the other side of the face, the other hand and the other side of the décolletage is left untreated. The face, the hands and the décolletage will be evaluated separately for both the efficacy and the safety parameters.

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.
30

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

  • Germany
      • Hamburg, Germany, 20146
        • University of Hamburg

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

40 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Signed informed consent obtained
  • Female subjects 40-65 years of age, inclusive.
  • Visible signs of skin aging in the face, hands and décolletage (e.g. reduced skin elasticity, reduced turgor, actinic elastosis, smaller and larger wrinkles) according to the Investigators opinion.
  • Subjects must be cooperative and willing to comply with the instructions and procedures.

Exclusion Criteria:

  • Extensively photo damaged and aged skin according to the Investigators opinion.
  • Active skin disease, inflammation or related conditions, such as infection, perioral dermatitis, seborrheic eczema and rosacea in the face, hands or décolletage.
  • History of or active collagenosis (e.g. systemic lupus, erythematosis, Rheumatic arthritis, skin or systemic sclerosis)
  • Previous hypersensitivity to hyaluronic acid.
  • Concomitant therapy with thrombolytics or anticoagulants, or have taken inhibitors of platelet aggregation, within 2 weeks before the baseline visit.
  • History of cancerous or pre-cancerous lesions in the face, hands and décolletage.
  • Previous tissue augmenting therapy with non-permanent filler or treatment with botulinum toxin, aesthetic surgical therapy, laser treatment, mesotherapy, or any form of peeling in the face, hands or décolletage within 12 months prior to the baseline visit.
  • Use of injectable revitalization preparations (e.g. Hyal System®, Restylane Vital) within 12 months prior to the baseline visit.
  • Use of retinoic acid within 6 months prior to the baseline visit.
  • Previous or concomitant treatment with chemotherapy, immunosuppressive agents or corticoids.
  • History of treatment with permanent filling materials.
  • Pregnancy or breast feeding woman or woman of childbearing potential not practicing adequate contraception.
  • Participation in any other clinical study within 30 days prior to the baseline visit or plan to participate in another clinical study during this study period.
  • Unrealistic expectation with regard to the esthetic results of the treatment.
  • Planned or ongoing weight reduction program during the study.
  • Known history of drug or alcohol abuse within 6 months prior to the baseline visit.
  • Known hypersensitivity to one or more components of EMLA cream®.
  • Any medical condition that in the opinion of the Investigator makes the subject unsuitable for inclusion (e.g. severe chronic disease, malignancy, bleeding disorder, skin diseases etc).
  • Other condition preventing the subject to entering the study in the Investigator's opinion e.g. subjects anticipated to be unreliable, unable to return for the follow-up visits, not likely to avoid other prohibited treatments or procedures or incapable of understanding the information or instructions.
  • Nicotine use during the study or stopped within 12 months before the baseline visit.
  • Study staff or close relative of study staff (e.g. parents, children, siblings and spouse).

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: SINGLE_GROUP
  • Masking: NONE

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.
OTHER: Untreated
Other: No treatment
One side of face, one hand and one side of the décolletage is left untreated as a control.
ACTIVE_COMPARATOR: Restylane Vital Light
Restylane Vital Light administered at 3 treatment sessions 4 weeks apart
Device: Restylane Vital Light
Treatment of up to 4 ml for one side of the face, one hand and one side of the décolletage dispensed by 10ul doses 0.5-1 cm apart. 3 treatment sessions 4 weeks apart.
Other Names:
  • Restylane skinbooster

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
Elasticity
Time Frame: 0,4,8,12,20,28,36 weeks
To evaluate the change in elasticity from baseline for the treated and untreated side respectively.
0,4,8,12,20,28,36 weeks
GEIS subject
Time Frame: 4,8,12,20,28,36 weeks
To evaluate esthetic change from baseline as judged by the subjects using GEIS for the treated and untreated side respectively
4,8,12,20,28,36 weeks
GEIS blinded evaluator
Time Frame: 12,20,28,36 weeks
To evaluate esthetic change from baseline as judged by the blinded evaluator using GEIS for the treated and untreated side respectively,
12,20,28,36 weeks
Skin structure
Time Frame: 0,4,8,12,20,28,36 weeks
To evaluate the change in skin structure from baseline for the treated and untreated side respectively.
0,4,8,12,20,28,36 weeks
Subject satisfaction
Time Frame: 0,12,20,28,36 weeks
To evaluate subject satisfaction
0,12,20,28,36 weeks
Best skin quality by blinded live evaluation
Time Frame: 12,20,28,36 weeks
To evaluate best skin quality of treated and untreated side judged by a blinded live evaluation
12,20,28,36 weeks

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
Adverse Events
Time Frame: 0-36 weeks
To evaluate the safety of Restylane Vital White during the whole study by collecting Adverse Events
0-36 weeks
Subject diary
Time Frame: 2 weeks after each treatment
To evaluate the acute safety profile, i.e. treatment procedure reactions by direct questioning to subjects in a diary used daily for 2 weeks after each injection.
2 weeks after each treatment

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.
  • Principal Investigator: Martina Kerscher, Professor, University of Hamburg, Prof. Dr. Martina Kerscher, Department Chemie, Martin-Luther-King Platz 6, 20146 Hamburg

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

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 1, 2009

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.
July 1, 2010

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 1, 2010

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 30, 2011

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.
August 8, 2011

First Posted (ESTIMATE)

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.
August 9, 2011

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.
August 25, 2022

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.
August 24, 2022

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.
November 1, 2012

More Information

Terms related to this study

Keywords

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.
  • 31GR0803

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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