Status and phase
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Treatments
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Ability to adequately understand the verbal explanations and the written participant 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.
Participant interested in improving skin quality.
Immune-competent adult 30 years of age and older.
Has intent to undergo treatment to improve appearance of the facial skin.
Willingness to comply with pre-visit instructions, including shaving of facial area (for male participants), to allow for consistent biometric and photographic evaluations.
If the participant is a female of childbearing potential, she agrees to use an acceptable form of effective birth control for the duration of the study and is willing to take a urine pregnancy test (UPT) at Baseline and prior to receiving any study treatment.
Acceptable forms of effective birth control include:
Negative UPT for women of childbearing potential at the Baseline visit.
Stable lifestyle and skincare regimen for at least 4 weeks
Exclusion criteria
Known or suspected allergy or hypersensitivity to any components of Revanesse® Renew™+
Known allergy or intolerance to topical anesthetics or lidocaine.
History of hypersensitivity reactions such as anaphylaxis, angioedema, or other severe allergic responses.
History of hypertrophic scarring, keloid formation, or post-inflammatory hyperpigmentation following cosmetic treatments.
Tattoos, piercings, or skin bleaching agents in the treatment area that may interfere with assessments, as judged by the Investigator.
Previous cosmetic or dermatologic procedures in the treatment area within the following time frames:
Previous treatment with cross-linked hyaluronic acid dermal fillers in the treatment area within the last 12 months.
Energy-based devices (laser, IPL, RF, ultrasound) in the last 6 months.
Microneedling, dermabrasion, mesotherapy, or chemical peels in the last 6 months.
Use of topical corticosteroids, retinoids, or depigmenting agents in the treatment area within the past 4 weeks.
Current use of immunosuppressive therapy, systemic corticosteroids, or chemotherapy within the last 3 months.
History of systemic autoimmune, collagen vascular, or bleeding disorders (e.g., lupus, scleroderma, thrombocytopenia).
Current pregnancy, positive urine pregnancy test at screening, breastfeeding, or intent to become pregnant during the study.
Participation in another clinical study within the past 30 days or concurrent participation in another interventional trial.
Any condition, including psychological, cognitive, or behavioral concerns, that would interfere with the ability to give informed consent, follow the protocol, or comply with follow-up requirements.
Initiation of a weight loss program or GLP-1 agonist therapy within 30 days before baseline or planned during study period.
Current participation by study personnel, immediate family members, or employees of the Sponsor.
History of cancer or previous radiation near or on the area to be treated.
Heavy smokers, classified as smoking more than 12 cigarettes per day.
Presence of any disease or lesions near or on the area to be treated, e.g.
Skin coloring/bleaching/tattoo in the treatment area, which, in the Treating Investigator's opinion, would interfere with the study injections and/or study assessment.
An underlying known disease, a surgical or medical condition that would expose the participant to undue risk, e.g. history of bleeding disorders, active hepatitis, active autoimmune disease such as connective tissue diseases, systemic lupus erythematosus, polymyositis, dermatomyositis, multiple sclerosis or scleroderma.
Use of concomitant medication that have the potential to prolong bleeding times such as anticoagulants or inhibitors of platelet aggregation (e.g., warfarin, clopidogrel, aspirin, baby aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), Omega 3 or Vitamin E), within 14 days prior to injection. Omega 3 and Vitamin E are acceptable only as part of a standard Topical Multivitamin formulation. Cyclooxygenase-2 (COX 2) inhibitors are allowed.
Treatment with chemotherapy, immunosuppressive agents, systemic corticosteroids within 3 months before treatment (inhaled or ophthalmic corticosteroids are allowed).
Use of hormonal therapy (ex. HRT or contraceptives) unless the participant has been on a stable dose for at least 3 months prior to screening and does not plan to make any changes to the HRT regimen during the study period.
Pregnancy (confirmed by positive urine pregnancy test (UPT)/ serum pregnancy test), breast feeding or intends to become pregnant over the duration of the study.
Primary purpose
Allocation
Interventional model
Masking
14 participants in 2 patient groups
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Central trial contact
Laura Raco, MSc
Data sourced from clinicaltrials.gov
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