Revanesse® Renew™+ (Prollenium Medical Technologies Inc.) is a non-crosslinked HA skin booster that combines low- and high-molecular-weight HA at a concentration of 14 mg/mL in a sterile aqueous gel for intradermal injection7. This dual-weight formulation provides both rapid hydration and sustained moisture retention, improving dermal suppleness and promoting subtle textural refinement through physiologic hydration rather than volumization. The present study is designed to compare biweekly and monthly treatment schedules of Revanesse® Renew™+, assessing clinical efficacy, objective biophysical markers, and participant-reported outcomes to inform evidence-based treatment protocols in aesthetic medicine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
14
Revanesse® Renew™+, a sterile, colorless, odorless, transparent, aqueous gel of synthetic origin supplied in pre-filled disposable syringes. Revanesse® Renew™+ is manufactured by Prollenium Medical Technologies Inc. It consists of both low- and high-molecular-weight hyaluronic acid (HA) at a concentration of 14 mg/mL. The product is supplied in pre-filled disposable syringes, each containing 1.2 mL of ready-to-use gel intended for single use. The product does not require reconstitution or dilution prior to injection and is administered directly into the superficial to mid-dermal plane according to the manufacturer's instructions.
Erevna Innovations Inc.
Montreal, Quebec, Canada
RECRUITINGGlobal Aesthetic Improvement Scale (GAIS) Score Assessed by Blinded Evaluat
Proportion of participants rated as "improved" (improved, much improved, or very much improved) on the GAIS by a blinded evaluator at the end of the study
Time frame: Baseline to Week 12 (Group 1) and Week 16 (Group 2)]
Safety and Tolerability of Treatment - Patient reported
Incidence and frequency of adverse events
Time frame: Baseline to Week 12 (Group 1) and Week 16 (Group 2)]
Safety and Tolerability of Treatment - Physician recoded
Incidence and frequency of adverse events
Time frame: Baseline to Week 12 (Group 1) and Week 16 (Group 2)]
Participant Satisfaction With Treatment
Proportion of participants who report being at least "satisfied" (satisfied, very much satisfied, or extremely satisfied) on a seven-point participant satisfaction scale Proportion of participants who report being at least "satisfied" (satisfied, very much satisfied, or extremely satisfied) on a seven-point participant satisfaction scale Proportion of participants rated as "improved" (improved, much improved, or very much improved) on the GAIS by a blinded evaluator at the end of the study
Time frame: Week 2 to Week 12 (Group 1) and Week 4 to Week 16 (Group 2)
Percentage Change in Skin Hydration
The percentage change in skin hydration from baseline to Visit 4,5,6 will be assessed to compare the effects of biweekly versus monthly administration of Revanesse® Renew™+ treatment. Assessment will be made using the Corneometer CM 825 (Courage+Khazaka electronic GmbH).
Time frame: Baseline to Week 12 (Group 1) and Week 16 (Group 2)
Change in Transepidermal Water Loss (TEWL) From Baseline
Percentage change in TEWL from Baseline to Visit 4,5,6, measured using the Tewameter TM 21.
Time frame: Baseline to Week 12 (Group 1) and Week 16 (Group 2)
Change in Skin Surface Biophysical Parameters From Baseline
Percentage change in surface evaluation of living skin cells (SELS: roughness, scaliness, smoothness, desquamation, and pore size) from baseline to Visit 4,5,6, measured via the VisioScan
Time frame: Baseline to Week 12 (Group 1) and Week 16 (Group 2)
Change in Skin Elasticity From Baseline
Percentage change in skin elasticity from baseline to Visit 4,5,6, measured using the Cutometer Dual MPA 580
Time frame: Baseline to Week 12 (Group 1) and Week 16 (Group 2)
Change in VISIA® CR Facial Imaging Metrics
Percentage change from Baseline in VISIA® CR-derived facial metrics as assessed by non invasive analysis of facial images
Time frame: Baseline to Week 12 (Group 1) and Week 16 (Group 2)
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