AestheticsNCT01412190
Study to Evaluate Restylane Vital Light Using an Injector Device
A study testing Restylane Vital Light and No treatment in people with Aesthetics, run by Galderma R&D at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aesthetics
- What is being tested?
- Restylane Vital Light and No treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2009to Jul 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Aesthetics
- Being tested
- Restylane Vital Light, No treatment
- Keywords
- Skin rejuvenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane Vital LightDevice
Also called Restylane skinbooster
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.
No treatmentOther
One side of face, one hand and one side of the décolletage is left untreated as a control.
| Study group | Role | What they receive |
|---|---|---|
| Untreated | Other | Not described Receives: Other: No treatment |
| Restylane Vital Light | Active comparator | Restylane Vital Light administered at 3 treatment sessions 4 weeks apart Receives: Device: Restylane Vital Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elasticity
To evaluate the change in elasticity from baseline for the treated and untreated side respectively.
Measured: 0,4,8,12,20,28,36 weeks
GEIS subject
To evaluate esthetic change from baseline as judged by the subjects using GEIS for the treated and untreated side respectively
Measured: 4,8,12,20,28,36 weeks
GEIS blinded evaluator
To evaluate esthetic change from baseline as judged by the blinded evaluator using GEIS for the treated and untreated side respectively,
Measured: 12,20,28,36 weeks
Skin structure
To evaluate the change in skin structure from baseline for the treated and untreated side respectively.
Measured: 0,4,8,12,20,28,36 weeks
Subject satisfaction
To evaluate subject satisfaction
Measured: 0,12,20,28,36 weeks
Best skin quality by blinded live evaluation
To evaluate best skin quality of treated and untreated side judged by a blinded live evaluation
Measured: 12,20,28,36 weeks
Secondary outcomes (2)
Adverse Events
To evaluate the safety of Restylane Vital White during the whole study by collecting Adverse Events
Measured: 0-36 weeks
Subject diary
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.
Measured: 2 weeks after each treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2011 (estimated)
- Study startApr 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AestheticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martina Kerscher, Professor, Principal investigator, University of Hamburg, Prof. Dr. Martina Kerscher, Department Chemie, Martin-Luther-King Platz 6, 20146 Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01412190
- Sponsor's protocol ID
- 31GR0803
- Status last verified
- Nov 2012
- First submitted
- 30 Jun 2011
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01412190
- Acronym / sponsor ID
- 31GR0803
- Conditions
- Aesthetics
- Keywords
- Skin rejuvenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 9 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Untreated | Other | Other: No treatment |
| Restylane Vital Light | Active comparator | Device: Restylane Vital LightRestylane Vital Light administered at 3 treatment sessions 4 weeks apart |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restylane Vital LightAlso: Restylane skinboosterTreatment 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. | Device | Restylane Vital Light |
| No treatmentOne side of face, one hand and one side of the décolletage is left untreated as a control. | Other | Untreated |
Primary outcome
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.
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
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,
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.
Subject satisfaction
Time frame: 0,12,20,28,36 weeks
To evaluate subject satisfaction
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
2 secondary outcomes
Adverse Events
Time frame: 0-36 weeks
Subject diary
Time frame: 2 weeks after each treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martina Kerscher, Professor principal investigator
University of Hamburg, Prof. Dr. Martina Kerscher, Department Chemie, Martin-Luther-King Platz 6, 20146 Hamburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restylane Vital Light and No treatment in people with Aesthetics, run by Galderma R&D at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elasticity (time frame: 0,4,8,12,20,28,36 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.