Decolletage RejuvenationPhase 4NCT04488939
Restylane® Skinboosters™ Vital in the décolletage Region
A Phase 4 study testing Restylane® Skinboosters™ Vital (SBV) in people with Decolletage Rejuvenation, run by Erevna Innovations Inc. at 1 site in Canada.
Trial summary
Restylane® Skinboosters™ Vital (SBV) is a smooth formulation without particles, which helps it distribute evenly and smoothly under the skin to aid in rejuvenation. This feature makes RSV particularly well suited for more superficial injections, such as at the level of the dermis. Read more about this study
- Who is it for?
- Ages 25 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Decolletage Rejuvenation
- What is being tested?
- Restylane® Skinboosters™ Vital (SBV)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- 6 Mar 2020to 31 Dec 2020
- Phase
- Phase 4
- 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 25 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A score > 2 on the GDS, as assessed by the treating physician at Baseline.
- Females aged > 25 and < 70
- Ability to adequately understand the verbal explanations and the written subject information provided in local language and ability and willingness to give consent to participate in the study.
- Signed and dated informed consent to participate in the study and unrestricted use of décolletage images for marketing purpose.
- If female of childbearing potential: a negative urine pregnancy test before all treatments is required.
Who cannot join
- Current Pregnancy or lactation [sexually active women of childbearing age must agree to use medically acceptable methods of contraception for the duration of this study (e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)];
- Patients meeting any official Restylane contra-indications;
- Inability to comply with follow-up and abstain from other treatments in the region of interest during the study period;
- Heavy smokers, classified as smoking more than 12 cigarettes per day;
- History of severe or multiple allergies manifested by anaphylaxis;
- Previous tissue revitalization therapy in the treatment area within 6 months before treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling, or dermabrasion;
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- Subjects presenting with known allergy to hyaluronic acid (HA) filler or amide local anesthetics.
- Subjects presenting with porphyria.
- Subjects with active disease, such as inflammation, infection or tumors, in or near the intended treatment site.
- Subjects with bleeding disorders or in subjects who are taking thrombolytics or anticoagulants.
- Subjects using immunosuppressants.
- History of other décolletage treatment/procedure in the previous 6 months below the level of the neck that, in the treating investigator's opinion, would interfere with the study injections and/or study assessments or exposes the subject to undue risk by study participation.
- Tattoos, piercings or visible markings that in the treating investigator's opinion, may interfere with results or assessments [excessive sun damage, tan lines, dark spots, moles, scars (hypertrophic, keloid), tan lines].
- Cancer or precancer in the treatment area, e.g. actinic keratosis;
- History of bleeding disorders or treatment with thrombolytics, anticoagulants, or inhibitors of platelet aggregation (e.g. Aspirin or other non-steroid anti-inflammatory drugs [NSAIDs]), within 2 weeks before treatment;
- Patients using immunosuppressants;
- Patients with a tendency to form hypertrophic scars or any other healing disorders;
- Patients with known hypersensitivity to lidocaine or agents structurally related to amide type local anesthetics (e.g., certain anti-arrhythmics);
- Patients with epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Open-label Evaluation of Restylane® Skinboosters™ Vital in the décolletage Region
Restylane® Skinboosters™ Vital (SBV) is a smooth formulation without particles, which helps it distribute evenly and smoothly under the skin to aid in rejuvenation. This feature makes RSV particularly well suited for more superficial injections, such as at the level of the dermis.
SBV smooths fine lines and wrinkles and is intended to improve skin smoothness and appearance, as well as the elasticity and hydration of the skin in the face and dorsal hands. However, many clinicians have used SBV in other regions of the body. Given these attributes, SBV are particularly well suited for photo aged skin. A region that is susceptible to photo-ageing and may therefore benefit from the use of SBV is the décolletage. Photodamaged skin of the chest is characterized by atrophy, skin laxity, fine lines and wrinkles, dehydration and tactile roughness. Therefore, SBV may help to improve these signs of aging in the décolletage region.
Study Aim: To investigate the effectiveness and tolerability of SBV for rejuvenation of the décolletage region.
- Conditions
- Decolletage Rejuvenation
- Being tested
- Restylane® Skinboosters™ Vital (SBV)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane® Skinboosters™ Vital (SBV)Device
Hyaluronic acid
| Study group | Role | What they receive |
|---|---|---|
| Bilateral treatment | Experimental | Not described Receives: Device: Restylane® Skinboosters™ Vital (SBV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Galderma Décolletage Scale
Proportion of subjects achieving at least a one-point improvement on the Galderma Décolletage Scale (GDS), one month following the treatment regime (i.e., Visit 4; Week 12; one month after completing three treatments, each spaced one month apart). Scores: 0 (none) to 4 (severe)
Measured: Visit 4, Week 12
Secondary outcomes (1)
Galderma Décolletage Scale
Proportion of subjects achieving at least a one-point improvement on the Galderma Décolletage Scale , at Visits 5 and 6 (i.e., 2- and 3-months post treatment regime). Scores: 0 (non) to 4 (severe)
Measured: Visit 5 and 6 (Weeks 16 and 20)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start6 Mar 2020
- Primary completion30 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decolletage RejuvenationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erevna Innovations Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Nikolis, FRCSC, Principal investigator, Erevna Innovations Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488939
- Sponsor's protocol ID
- 2020-Gal-SBV
- Status last verified
- Jul 2020
- First submitted
- 22 Jul 2020
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label Evaluation of Restylane® Skinboosters™ Vital in the décolletage Region
- ClinicalTrials.gov ID
- NCT04488939
- Acronym / sponsor ID
- 2020-Gal-SBV
- Conditions
- Decolletage Rejuvenation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Erevna Innovations Inc.University, hospital or other
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 28 Jul 2020 (actual)
- 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.
Restylane® Skinboosters™ Vital (SBV) is a smooth formulation without particles, which helps it distribute evenly and smoothly under the skin to aid in rejuvenation. This feature makes RSV particularly well suited for more superficial injections, such as at the level of the dermis.
SBV smooths fine lines and wrinkles and is intended to improve skin smoothness and appearance, as well as the elasticity and hydration of the skin in the face and dorsal hands. However, many clinicians have used SBV in other regions of the body. Given these attributes, SBV are particularly well suited for photo aged skin. A region that is susceptible to photo-ageing and may therefore benefit from the use of SBV is the décolletage. Photodamaged skin of the chest is characterized by atrophy, skin laxity, fine lines and wrinkles, dehydration and tactile roughness. Therefore, SBV may help to improve these signs of aging in the décolletage region.
Study Aim: To investigate the effectiveness and tolerability of SBV for rejuvenation of the décolletage region.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bilateral treatment | Experimental | Device: Restylane® Skinboosters™ Vital (SBV) |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A score > 2 on the GDS, as assessed by the treating physician at Baseline.
- Females aged > 25 and < 70
- Ability to adequately understand the verbal explanations and the written subject information provided in local language and ability and willingness to give consent to participate in the study.
- Signed and dated informed consent to participate in the study and unrestricted use of décolletage images for marketing purpose.
- If female of childbearing potential: a negative urine pregnancy test before all treatments is required.
Key exclusion criteria (19 listed)
- Current Pregnancy or lactation [sexually active women of childbearing age must agree to use medically acceptable methods of contraception for the duration of this study (e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)];
- Patients meeting any official Restylane contra-indications;
- Inability to comply with follow-up and abstain from other treatments in the region of interest during the study period;
- Heavy smokers, classified as smoking more than 12 cigarettes per day;
- History of severe or multiple allergies manifested by anaphylaxis;
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® Skinboosters™ Vital (SBV)Hyaluronic acid | Device | Bilateral treatment |
Primary outcome
Galderma Décolletage Scale
Time frame: Visit 4, Week 12
Proportion of subjects achieving at least a one-point improvement on the Galderma Décolletage Scale (GDS), one month following the treatment regime (i.e., Visit 4; Week 12; one month after completing three treatments, each spaced one month apart). Scores: 0 (none) to 4 (severe)
1 secondary outcome
Galderma Décolletage Scale
Time frame: Visit 5 and 6 (Weeks 16 and 20)
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 10 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Decolletage Rejuvenation
Not yet recruitingEarly Phase 1
PIEZO-101 First-in-Human Safety and Proof-of-Concept Study
Skin Aging, Wrinkles in Decolletage
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.
Andreas Nikolis, FRCSC principal investigator
Erevna Innovations Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Restylane® Skinboosters™ Vital (SBV) in people with Decolletage Rejuvenation, run by Erevna Innovations Inc. at 1 site in Canada.
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 5 inclusion and 19 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 10 Feb 2021. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Galderma Décolletage Scale (time frame: Visit 4, Week 12). 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 10 Feb 2021.