Restylane® Skinboosters™ Vital in the décolletage Region

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.

Study Overview

• Status: Completed
• Conditions: Decolletage Rejuvenation
• Intervention / Treatment: Device: Restylane® Skinboosters™ Vital (SBV)

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3R 3A1
      • Erevna Innovations Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. A score > 2 on the GDS, as assessed by the treating physician at Baseline.
2. Females aged > 25 and < 70
3. 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.
4. Signed and dated informed consent to participate in the study and unrestricted use of décolletage images for marketing purpose.
5. If female of childbearing potential: a negative urine pregnancy test before all treatments is required.

Exclusion Criteria:

1. 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)];
2. Patients meeting any official Restylane contra-indications;
3. Inability to comply with follow-up and abstain from other treatments in the region of interest during the study period;
4. Heavy smokers, classified as smoking more than 12 cigarettes per day;
5. History of severe or multiple allergies manifested by anaphylaxis;
6. 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;
7. Subjects presenting with known allergy to hyaluronic acid (HA) filler or amide local anesthetics.
8. Subjects presenting with porphyria.
9. Subjects with active disease, such as inflammation, infection or tumors, in or near the intended treatment site.
10. Subjects with bleeding disorders or in subjects who are taking thrombolytics or anticoagulants.
11. Subjects using immunosuppressants.
12. 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.
13. 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].
14. Cancer or precancer in the treatment area, e.g. actinic keratosis;
15. 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;
16. Patients using immunosuppressants;
17. Patients with a tendency to form hypertrophic scars or any other healing disorders;
18. Patients with known hypersensitivity to lidocaine or agents structurally related to amide type local anesthetics (e.g., certain anti-arrhythmics);
19. Patients with epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bilateral treatment	Device: Restylane® Skinboosters™ Vital (SBV); Hyaluronic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Visit 4, Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Visit 5 and 6 (Weeks 16 and 20)

Collaborators and Investigators

• Sponsor: Erevna Innovations Inc.
• Investigators: Principal Investigator: Andreas Nikolis, FRCSC, Erevna Innovations Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2020
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: July 22, 2020
• First Submitted That Met QC Criteria: July 24, 2020
• First Posted (Actual): July 28, 2020

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 7, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2020-Gal-SBV

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