Status:
COMPLETED
Restylane® Skinboosters™ Vital in the décolletage Region
Lead Sponsor:
Erevna Innovations Inc.
Conditions:
Decolletage Rejuvenation
Eligibility:
FEMALE
25-70 years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
March 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04488939
Start Date
March 6 2020
End Date
December 31 2020
Last Update
February 10 2021
Active Locations (1)
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1
Erevna Innovations Inc
Montreal, Quebec, Canada, H3R 3A1